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PO 215 Ed. 07 REF. CER_Oscar3_ C.1.1_Rev.

Clinical Evaluation Report


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1. INTRODUCTION

A manufacturer of a medical device must demonstrate that the intended purpose(s) and claim(s)
made in relation to safety and performance of a Medical Device are achieved, as referred to in the
Medical Device Directives. As a general rule, such demonstration will require clinical data. Clinical
data is data which is relevant to the various aspects of the clinical safety and performance of the
device. This may include data from prospective and retrospective clinical investigations of the
device concerned as well as market experience of the same or equivalent devices and medical
procedures and information from the scientific literature. Clinical evaluation is based on the
assessment of the risks and the benefits, associated with the use of the device, through either a
compilation of relevant scientific literature or the results of a clinical investigation or both of these.

Orthofix Srl has determined that in order to fulfil the above essential requirements of the Medical
Device Directive it is necessary to conduct a Clinical Evaluation to determine whether or not
sufficient clinical data exists to demonstrate the necessary safety and performance criteria for the
Orthofix Oscar Ultrasonic Arthroplasty Revision Instrument device.

This Clinical Evaluation Report is prepared according to the European Guideline MEDDEV
2.7/1 Rev. 4, and it updates and replaces previous reports.

2. DEVICE DESCRIPTION

This paragraph has been prepared on the basis of the information provided in the device IFU
Version PQ OSC B 02/17, Operative Technique Version OS-1501-OPT-E0 B 01/16, and commercial
brochure Version OS-1601-PL-E0 A 12/16. These documents are available in Annex B.

The Orthofix Oscar Ultrasonic Arthroplasty Revision Instrument is an ultrasonic device that is
applied in Orthopaedics to facilitate bone cement removal during arthroplasty revision surgeries
and to perform bone osteotomies when needed. Hereafter, we will simply refer to the device as
Oscar.

The OSCAR system is comprised of a portable generator which has 2 output channels. Both output
channels drive cement removal or osteotome handsets. A large range of cement removal and
osteotome probes are available. Depending on the application, some probes are single-use, and
provided sterile, while other are reusable and provided non-sterile.

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For more details regarding the components of the Oscar device, and relative images, refer to
Annex B.

The operating principles are as follows: the generator supplies a high frequency alternate signal to
the piezoelectric stack transducer in the handset. This makes the probe resonate at an ultrasonic (>
16kHz) frequency. When the probe is placed adjacent to bone cement it causes it to melt. When
the probe is placed adjacent to bone, it cuts it.

The device is an active, non-implantable, surgically invasive device as it penetrates inside the body
through the surface of the body in the context of a surgical operation. The duration of use/contact
with the body is transient (less than 60 minutes). The device gets in contact with the patient’s bone
tissue, and with the patient’s blood.

Summarizing, the main features of the Oscar device are as follows:

Regulatory class: IIb (93/42/EEC Directive as amended, Annex IX, Rule 9, first
paragraph)

Materials:

Handsets: Stainless steel case, titanium, silicone and viton components

Probes: A titanium alloy (Ti6Al4V)

Single use/reusable: Some probes are reusable while others are single-use.

Sterile: Single-use probes are provided sterile.

Radioactivity: The device is not radioactive.

Conditions of use: All Orthofix devices are intended for professional use only. Surgeons
who supervise the use of Orthofix devices must have full awareness
of orthopaedic and, specifically, of arthroplasty revision procedures.

Indications: The Oscar Ultrasonic Arthroplasty Revision Instrument is intended


for cutting and removal of bone and acrylic bone cement in
orthopaedic applications.

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Target population: The target treatment group are those patients undergoing
arthroplasty revisions and patients undergoing orthopaedic surgical
operations calling for an osteotomy to be performed.

Contraindications: Generally, the use of the device is contraindicated when the above
surgical operations are contraindicated. No other specific
contraindication to the use of the device exists. Yet, as no clinical
evaluation is available, Orthofix is unable to confirm the safety of use
of the OSCAR where a patient or an operator of the unit has been
fitted with a cardiac pacemaker. It is, therefore, left to the clinician’s
discretion as to the use of the OSCAR in this situation. However, no
adverse effects have been reported so far.

The device does not incorporate any medicinal substance, animal tissue or derivative or blood
component.

Orthofix is aware of the following CE-marked devices with the same intended use (bone cutting
and/or bone cement removal): Biomet Ultra-Drive 3, Mectron Piezosurgery Medical/Flex/Plus,
Misonix Ultrasonic BoneScalpel.
There are medical alternatives to the use of piezoelectric devices. Bone tissue cutting can be
performed through numerous means; from manual instruments, such as scalpels, hammers and
saws, to motorized tools, to laser and ultrasounds. Cement removal can also be performed using
various instruments, including conventional manual cement removal tools such as drills, burs,
curettes, and flexible osteotomes or motors driven tools, such as drills, burrs, and saws. For more
details, please refer to Section 4.

The Oscar device is CE-marked and is currently on the market in Europe and in Chile, Honk Kong,
Israel, Libya, Lebanon, Oman, Qatar, South Africa, Switzerland, United Kingdom.

It is registered also in Australia, New Zealand, USA, Puerto Rico, Saudi Arabia.

3. INTENDED PURPOSE, INTENDED THERAPEUTIC INDICATIONS AND


CONTRAINDICATIONS

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This paragraph has been prepared on the basis of the information provided in the device IFU
Version PQ OSC B 02/17, Operative Technique Version OS-1501-OPT-E0 B 01/16, and commercial
brochure Version OS-1601-PL-E0 A 12/16. These documents are available in Annex B.

The Orthofix Oscar Ultrasonic Arthroplasty Revision Instrument is intended to be used for cutting
and removal of bone and acrylic bone cement in orthopaedic applications.

The target treatment group are those patients undergoing arthroplasty revisions and patients
undergoing orthopaedic surgical operations calling for an osteotomy to be performed.

Generally, the use of the device is contraindicated when the above surgical operations are
contraindicated. No other specific contraindication to the use of the device exists. Yet, as no clinical
evaluation is available, Orthofix is unable to confirm the safety of use of the OSCAR where a
patient or an operator of the unit has been fitted with a cardiac pacemaker. It is, therefore, left to
the clinician’s discretion as to the use of the OSCAR in this situation. However, no adverse effects
have been reported. This information is made available to the user in the device IFU.

The OSCAR 3 device is intended to be used by surgeons trained in standard orthopaedic surgical
procedures and specifically trained in the use of ultrasonic surgical instruments.

Warning and precautions, as stated in IFU, are described below.

Warnings and Cautions

• Handle the acoustics (handset and probes) with care. Do not attempt to modify the acoustics.
Damage or changes can affect the ability to attain resonance and reduce the effectiveness of the
device. Do not use if damage is suspected.
• Sparks may be produced if the probes touch anything metal while activated. This equipment is
not to be used in the presence of flammable gases or liquids.
• Use only genuine OSCAR accessories to assure compatibility and compliance with the
requirements of 60601-1-2 in terms of emissions and immunity.
• The use of unofficial accessories (Handsets and cables), which are not OSCAR original
components may increase emission or decrease immunity of the OSCAR System.
• This device should only be used by qualified surgeons who are (1) suitably trained in the
arthroplasty revision surgery procedures that are to be carried out and (2) trained in the specific
use of ultrasonic surgical instruments intended for use during arthroplasty revision.
• OSCAR system must not be used adjacent to or stacked with other equipment.
• The probes may become hot during use. Do not allow the probes to contact tissue following
use.
• Do not allow the probes to contact tissue between activations, in case accidental activation
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• Care should be taken when operating in the vicinity of nerves.
• To avoid the risk of electric shock, thisPage 4 of 100 must only be connected to a grounded
equipment
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Warnings - In Use

• Do not operate OSCAR in the presence of flammable gases or liquids and an environment rich
with oxygen.
• Single use probes should not be reprocessed under any circumstances.
• As no clinical evaluation is available, Orthofix SRL is unable to confirm the safety of use of the
OSCAR where a patient or an operator of the unit has been fitted with a cardiac pacemaker. It
is, therefore, left to the clinician’s discretion as to the use of the OSCAR in this situation.
However, no adverse effects have been reported.
• Please take care of the handsets, probes and cables as rough treatment may affect the safety
and performance of the unit.
• The use of handsets or probes not supplied as part of the OSCAR system may damage the
generator and create a safety hazard for the operator and patient.
• Avoid allowing an energised probe to come into contact with any metal surface.
• Avoid touching or holding the probes when the handset is energised.
• The generator may be shutdown (disconnected) by use of the switch on the rear panel.
• Where possible, avoid allowing probes to become stuck in cement as this may cause the
generator thermal trip to operate. However, if this situation occurs refer to section Problems
and Solutions: Removal of probe stuck in cement.
• Do not allow an energised probe to come into firm contact with skin or muscle, as this will
cause a friction burn. Skin should be protected with a dry swab.
• Do not over tighten the probes to the handsets.
• The use of accessories, transducers and cables other than those specified, with the exception
of transducers and cables sold by Orthofix SRL as replacement parts for OSCAR may result in
increased emissions or decreased immunity.
• Servicing and maintenance activities shall be conducted in the absence of a patient.
• OSCAR should not be used adjacent to or stacked with other equipment. If adjacent or
stacked use is necessary OSCAR should be observed to verify normal operation in the
configuration in which it will be used.
• To avoid the risk of electric shock, this equipment must only be connected to a grounded
power supply.
• Mains Isolation is achieved by use of the double pole switch located on the rear panel.
• No modification of this equipment is required.
• Do not use OSCAR simultaneously with laser equipment or high frequency surgical
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Safety Precautions and Equipment Care

OSCAR Handset Cement Remover


Intensive use of Cement Removal Handset can cause warming of handset body. In such
situations, the user is advised either to increase the cooling time allowed, or to use a second
Cement Removal handset. In case of intensive use these are the potential temperature
reachable by handset:
• Cement Removal Handset (normal condition): 55 °C
• Osteotome Handset (normal condition): 47 °C
• Cement Removal Handset (single fault condition): 64 °C

OSCAR Bonecutter Single Use Probe


This probe should only be used with an Orthofix OSCAR Bonecutter system.
The probe has a screw thread fitting that couples to the handset in the same manner as all
OSCAR probes. This coupling should be tightened using an 8mm spanner/wrench.
This probe has been designed to be single use only. It is not designed to be reused in any way
whatsoever.
• Do not use if packaging is open or damaged.
• Probe damage may occur should it come into contact with any metal surface whilst activated.
Should this happen, remove the probe and replace with a new one.
•Do not use an energised probe and the endoscope simultaneously. This may damage the
probe and endoscope.
• Do not allow an energised probe to come into firm contact with skin or muscle, as this will
cause a friction burn. Skin should be protected with a dry swab.
• Do not over tighten the probes to the handsets.
• If a probe becomes damaged during a procedure and needs replacing, it is most important not
to get talcum powder, blood or any form of contamination on the mating surfaces. This will
cause them to become eroded and materially affect the ultrasonic conduction of the
waveguide, making it less efficient.
• If the probe is reused, there is a risk that it may be worn which will result in poor performance
or it may even fatigue which may lead to probe fracture.

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Safety Precautions and Equipment Care

OSCAR Single Use Probe


This probe should only be used with an Orthofix OSCAR system.
The probe has a screw thread fitting that couples to the handset in the same manner as all
OSCAR probes. This coupling should be tightened using an 7mm spanner/wrench.
This probe has been designed to be single use only. It is not designed to be reused in any way
whatsoever.
• Avoid allowing an energised probe to come into contact with any metal surface.
• Do not use an energised probe and the endoscope simultaneously. This may damage the
probe and endoscope.
• Where possible, avoid allowing probes to become stuck in cement as this may cause the
generator thermal trip to operate. However, if this situation occurs, refer to the OSCAR User
Manual section - Problems and Solutions - removal of probe stuck in cement.
• Do not allow an energised probe to come in firm contact with skin or muscle, as this will cause
a friction burn. Skin should be protected with a dry swab.
• Do not over tighten the probes to the handsets.
• If a probe becomes damaged during a procedure and needs to be replaced, it is most
important not to get talcum powder, blood or any form of contamination on the mating
surfaces of the probe and handset. This will cause them to become eroded and materially affect
the ultrasonic conduction of the waveguide, making it less efficient.
• If the probe is reused, there is a risk that it may be worn which will result in poor performance
or it may even fatigue which may lead to probe fracture.
• After use the probe should be disposed of. The handset should be cleaned and sterilised as
instructed in this document.

For instructions on how to handle Scratches on Probes, Damage or Wear on Piercer and Scraper
Cutting Heads, Damage or Wear on Cables please refer to IFU Version PQ OSC B 02/17 (Annex B).

Cleansing and Sterilising procedures (before and after use) are described in detail in IFU Version
PQ OSC B 02/17 (Annex B).

The instructions for irrigation, and its importance, are stated in the device IFU as follows below.

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Irrigation During Cement Removal

Irrigation of the bone canal following a period of cement removal is important for two reasons.
Firstly, it clears the canal of cement debris and secondly it maintains safe operating
temperatures. It is recommended that irrigation, in the form of pulsed lavage or manual
irrigation, is used intermittently following use of the scrapers or groover probes and that the
frequency of irrigation is more frequent when using the piercer probes.

It is recommended that irrigation is used more frequently in the following instances:


1. Cement removal in the upper extremity limbs
2. Knee revisions
3. Cases of femoral cortices which are particularly thin

Do not irrigate during ultrasonic energy application, this will compromise the speed of removal
and efficacy of transmission. The design of the OSCAR probes is specifically aimed at achieving
rapid heating and transference of the softened cement. Cooling during an energy cycle will
delay this action and reduce the energy available.

Notes: If possible chilled saline should be used Refer to video material of OSCAR use

Irrigation During Cementless Revision

It is important to maintain a steady flow of saline around the prosthetic stem during insertion of
the flat osteotomes, particularly when cutting cortical bone. This helps to keep the metal on
metal interface cool and lubricated whilst the active edges of the osteotome are cutting bone.

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4. CLINICAL BACKGROUND, CURRENT KNOWLEDGE, STATE OF THE ART


In this section, we first describe the strategy followed to conduct the state of the art research.
Then, we provide an overview on the ultrasound methods and on the applications of piezoelectric
device Oscar, i.e. bone cutting and bone cement removal during prosthesis revision surgery.

Literature search strategy


In order to retrieve information on current knowledge/the state of the art about the background,
use and expected clinical outcome of the Oscar device, a literature search was performed
searching the PubMed database. The PubMed database was selected because it collects data
stored in the Medline journal citation database of the US National Library of Medicine, concerning
more than 27 million biomedical publications, together with in-process citations, “ahead of print”
citations, and citations for books available on the US National Center for Biotechnological
Information (NCBI). Articles retrieved by using PubMed are all published in international well-
known, peer-reviewed scientific journals dealing with all aspects of trauma and orthopaedic
surgery and most of them having an impact factor. The studies accepted in such journals are
generally performed according to established scientific guidelines, characterized by an appropriate
design and unbiased measurements of outcome, and conducted after ethical committee
approvals. Finally, the peer-review process guarantees high scientific level, improves performance
and provides credibility and independence from biased and influenced evaluations.
The PubMed search was conducted using a software that creates search strings with all possible
combination of terms present in the different columns “Search Fields #”. Three literature searches
were performed in order to retrieve reviews using the key-terms and time limits indicated in the
tables below.

• Bibliographic Search 1
Term 1 Term 2 Time limit
revision arthroplasty bone cutting 01/01/2007-30/6/2017
revision surgery bone removal
orthopaedic acrylic bone cement
orthopedic
orthopaedics
orthopedics

This search produced 841 literature records; of those, 376 references were single records (not
duplicates).

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• Bibliographic Search 2
Term 1 Term 2 Time limit
ultrasound bone cutting 01/01/2007-30/6/2017
piezoelectric bone removal
Oscar 3 acrylic bone cement
Oscar III revision arthroplasty
ultrasonic bone cement removal
arthroplasty revision

This search produced 508 literature records; of those, 203 references were single records (not
duplicates).

• Bibliographic Search 3
Term Time limit
bone cutting 01/01/2007-30/6/2017
bone cement removal

This search produced 148 literature records; no duplicates were retrieved within the search.

The literature records were screened to exclude duplicate references (within the same
bibliographic search or between different searches), articles written in a language other than
English, articles not dealing with the topic of interest, articles that were not reviews.
At the end of the screening process, 11 references were deemed as useful to provide
information regarding the clinical background on the use of piezoelectric devices for bone cutting
or bone cement removal. References that were cited in these reviews and were considered
relevant to the state of the art were also included in the analysis of the clinical background. One
reference (Jasper at al., 2016) was retrieved through an independent PubMed search.
In conclusion, 35 references were included in the state of the art; the list of the references
is provided at the end of this section, and in Annex F. Full-texts are available in Annex B.

The ultrasound method


Ultrasound waves are a form of mechanical energy with a sound vibration above the audible level
(≥20kHz). Ultrasound has been used in clinical practice since the early 50s, initially for diagnostic
imaging then for its therapeutic/biological effects, depending on the wave frequencies used, such
as tissue heating, and for non-thermal mechanisms, such as bone cutting and cement removal
(Miller et al., 2012). Indeed, a short burst (pulse) or continuous waves deliver different amount of
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energy to the tissue, unfocused heating applied to bone or tendon can enhance tissue healing
without damage, concentrate heating has a coagulative effect and can be used for tissue ablation
purpose. Ultrasound waves are produced by two different methods: magnetostatic and
piezoelectric. Magnetostatic method converts electromagnetic energy into mechanical energy and
it is not used in clinical setting. On the contrary, the piezoelectric method has been used routinely
for clinical applications in many fields of surgery in the last thirty years. It is characterized by the
property of certain polarized materials, such as ceramics and crystals, to expand and contract
while an electrical field is applied to those materials. The electrical current passing in these
materials causes their deformation and is converted into mechanical oscillation at ultrasonic
frequency (Thomas et al., 2017). The ultrasonic waves are then transmitted to a metal tip, which
when applied with a slight pressure on the bone results in cutting of tissue. This system acts also
through others features such as (i) ultrasonic cavitation, a microboiling phenomenon occurring in
liquids on a solid-liquid interface when a liquid is subjected to a rapid change in pressure leading
to the formations of vapor cavities (small liquid-free zones called "bubbles" or "voids") and (ii)
tissue healing process, ultrasound vibration facilitates bone healing at a cellular level accelerating
the acute inflammatory phase, and the proliferative and remodeling processes by increased level
of bone morphogenetic proteins in the cut site and controls of the inflammatory response with
fewer induction of pro-inflammatory cytokines (Labanca et al., 2008).

The piezoelectric effect was first described in 1880 by Jacques and Pierre Curie, when they
discovered that applying pressure on certain polarized materials creates electricity. First ultrasonic
devices were originally developed for dentistry for cavity preparation of human teeth. Then, Dr.
Richman introduced the first ultrasonic chisel for bone removing during apicoectomies and in 1960
Mazzarow’s equip used an ultrasonic scalpel-like blade for bone cutting. Since then, they were
quickly adapted, and their use was expanded to other medicine fields.

Piezoelectric devices usually consist of a hand-piece, a foot switch and a power unit. A
peristaltic pump jets an irrigation fluid, normally saline, that removes debris from the cutting area
inducing a cavitation effect that helps to maintain good visibility in the operative field by
dispersing the fluid as an aerosol that keeps the area of the irrigation blood-free. The flow is
adjustable (0-60 ml/min) and it is refrigerated at 4°C for cooling the surgery area (Thomas et al.,
2017). A frequency of 25–29 kHz is used to cut only mineralized tissue such as bones while soft
tissue cutting happens in the range of 50 kHz (Labanca et al, 2008). The power unit may have
three different power levels: low mode for orthodontic surgery, high mode for cleaning, and a
boosted mode for osteotomy and osteoplasty. There is a range of inserts (tips) available, which
can vary in size, shape and material depending on the surgery purpose. There are extensive
indications of piezo surgery in dental implantology and oral and maxillofacial bone surgery,
however in literature other surgical disciplines such as craniofacial surgery, plastic and

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reconstructive surgery, head and neck surgery, neurosurgery, ophthalmology, traumatology,
orthopedics and hand surgery are reported (Yaman and Suer, 2013).

Bone cutting
In surgical operations bone surgery interventions consist of a combination of performing cutting
action (osteotomy) and remodeling (osteoplastic procedures) of the bone surface.
Critical points in osteotomy are: to achieve a high accuracy and precision in bone cutting together
with safety and rapidity of the recovery.
Bone tissue cutting can be performed through numerous means; from manual and
motorized tools, to laser and ultrasounds. Manual and motorized instruments are considered the
traditional tools for bone surgery. Manual techniques, such as scalpels, hammers and saws,
depend to the mechanical force exerted by the surgeon, therefore they may have a good cutting
efficacy, but not easily controllable. In motor-driven instruments the cutting capacity is related to
electric energy and mechanical force; the cutting is, therefore, the result of rotation produced by
the movement of a drill or by the oscillating movement of a saw plus the pressure exerted on the
handle (Marco et al., 2014). Therefore, drilling process may result in frictional heat and thermal
necrosis, damaging the edge of the bone surrounding the drilled hole where the fixation screw will
be located and leading to osteonecrosis. Drilling is extensively used in orthopedics, traumatology
and dentistry. Bone grinding is often used for plane bones, such as the skull base, in neurosurgery
together with endoscopic technologies. Bone milling is used in surgery where an accurate
machining of the bone surface is required, for instance in the total knee arthroplasty. Under
various cutting conditions this tool can reach 49°C to 115°C, and the thermal damage may reach
about 2 mm in depth. Eriksson et al. showed that local bone necrosis would occur when the
temperature exceeds 47°C for 1 minute (Eriksson et al., 1984). Conventional osteotomies need a
constant physical pressure of the hand piece on the bone surface to increase the effectiveness of
the cut, limiting the precision and the sensitivity. Therefore, it is difficult to determine the cutting
depth. For instance, during an osteotomy of more mineralized bones the high pressure exerted
suddenly becomes excessive when the cortical bone is finished, causing an immediate loss of
control of the surgical tool, a condition that can become very dangerous in close proximity of
delicate anatomical structures, such as nerves and vessels. Thus, the surgical sensitivity and the
control of the tool are reduced when there are structures presenting different mineralization
(Yaman and Suer, 2013). Indeed, the injury caused to surrounding living tissues or neurovascular
system can lead to detrimental outcome for the patient and decelerate wound healing. Also, all
these tools reach an excessive temperature inducing thermal necrosis in the tissue surrounding
the cutting zone and in the bone itself impairing bone regeneration.

Several parameters are involved in heat generation during cutting, such as the type of
approach, the structure and density of the bone tissue and the cutting force exerted on the handle
(Marco et al., 2014). Furthermore, traditional motorized instruments, especially the saw, generate

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macrovibrations reducing the surgical safety. Even if the traditional cutting tools have improved
over time, together with the learning curve of the operator, the risks have been reduced
dramatically, but not completely. In particular, in maxillofacial surgery and neurosurgery the
osteotomies are conducted close to delicate anatomic structures that can be damaged
mechanistically and subjected to thermal necrosis. Choosing which method to adopt is of the
greatest importance and it depends on various factors: type of implant, bone type and location,
and the need to protect surrounding tissue from mechanical and heat transfer damages (Labanca
et al, 2008).

Bone cutting using piezoelectric devices

The development of piezoelectric techniques was driven by the urge to get greater precision and
safety in bone surgery than with manual and motorized surgical tools. As described in the first
section, the principle of piezosurgery is ultrasonic transduction, obtained by piezoelectric ceramics
or crystals contraction and expansion. The vibrations are amplified and transferred into the insert
tip which, when applied rapidly with slight pressure and in the presence of irrigation with
physiological solution, results in the cavitation phenomenon, with a mechanical cutting effect,
exclusively on mineralized tissue.

Over the past two decades, a large amount of literature has showed benefit using
piezosurgery method and there is a wide range of methods now in use and applied in several
surgery’s fields, such as dental implantology, oral and maxillofacial surgery, craniofacial surgery,
plastic and reconstructive surgery, head and neck surgery, neurosurgery, ophthalmology,
traumatology, orthopedics, hand surgery and pediatric surgery (Labanca et al., 2008; Yaman and
Suer, 2013). Piezosurgery was introduced as a technique that would further reduce the major risks
in osteotomy (bleeding, osteonecrosis and damage to soft tissue).

As mentioned above, piezoelectric devices usually consist of a hand-piece and foot switch
and a power unit. Then, a peristaltic pump jets a refrigerated irrigation fluid inducing a cavitation
effect that helps to maintain good visibility in the operative field and to cool down the surgery
area (Thomas et al., 2017). A frequency of 25–29 kHz is used for bone cutting. The insert tips
available have linear vibration ranging from 60 to 200 µm and can be classified in: (i) sharp insert
tip, for osteoplasty techniques or for harvesting bone chips; (ii) smooth insert tip, for precise and
controlled work on bone structure and (iii) blunt insert tips, for preparing soft tissue (for example
for preparing root planning in periodontics) (Thomas et al., 2017). The most effective way to use
the hand piece is with high speed and low pressure because increasing the working pressure
causes its vibration to cease.

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Benefits and risks

The technique of piezoelectric surgery is three times more powerful than normal ultrasound,
therefore can cut highly mineralized bone, and offers several advantages over traditional manual
or power-driven methods (Robiony et al., 2004).
The frequency of 25-29 kHz allows highly precise cutting due to its micrometric and linear
vibrations with absolute confidence, particularly in close proximity to vessels, nerves, dura matters
and mucosa. The controlled motion of the device probe results in a neater and precise cut due to
the absence of macrovibrations. Indeed, the piezoelectric drill is the result of linear microvibration
with a range of only 20-60 ƞm in a longitudinal direction (Crosetti et al., 2009). In this way, a more
effective and safe osteotomy is achieved compared to traditional rotating or hand tools, also
thanks to a lesser surgeon’s strength required to make cuts. This modulated frequency of the
vibration produces an efficient cutting action on the bone of different mineralization without
leaving osseous fragments at the edge of the cut, that have been demonstrated to be the main
cause of overheating produced by normal ultrasound (Crosetti et al., 2009).
Another piezosurgery characteristic is its high specificity for mineralized tissues whilst
minimizing trauma to surrounding soft tissue. Indeed, differently from bone tissue, neurovascular
tissue and other soft tissues are cut with frequencies higher than 50kHz (Labanca et al., 2008).
Adapting the ultrasound frequency allows safe cutting of hard tissue and avoid any soft tissue
damage; adjacent soft tissue and nerve remain safe due to the cessation of the surgical action
when the insert tip meets non-mineralized tissues.
Regarding surrounding tissue damage with piezosurgery, Schaeren and co-workers
investigated the potential damage of piezosurgery to a peripheral nerve on direct contact in two
possible scenarios, using a rat model. The first one represents the worst-case scenario, in which
the surgeon does not immediately realize the contact with a nerve and continues to operate for 5
seconds; the second scenario corresponds to an accidental slip of the device on the bone tissue
(they estimated a higher force but for a shorter time, 1 second). They monitored the nerve
function from the first day after the surgery up to 150 days after injury. They concluded that even
in the worst-case scenario the perineurium of the nerve remained intact and the nerve was not
dissected, thus enhancing the potential for functional recovery (Schaeren et al., 2008). These
results are also in agreement with the finding of other studies; one study compared the use of
piezoelectric devices with conventional tools on soft and hard tissue for transposition of the
inferior alveolar nerve in sheep; another study assessed the neurosensory damage of the inferior
lip and chin after bilateral sagittal spit osteotomy in 20 patients. Both studies reported less
damage to soft tissue, particularly neurovascular tissue when using a piezoelectric device than
conventional methods (Labanca et al., 2008).

Cavitation effect, created by the interaction between the jet irrigation with physiological
saline solution and the oscillating insert tips keeps the surgical site clean from debris and blood
maintaining a better visualization in the operation field. Furthermore, it has been suggested that
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the cavitation effect has an anti-bacterial action because it fragments bacteria’s cell membranes
(Yaman and Suer, 2013).
Piezoelectric surgery offers advantage also on cell viability, which is important for
regenerative surgery. Indeed, piezoelectric surgery ranks among the best manual methods for
harvesting vital autologous bone. Successful bone regeneration depends on retaining the viability
of osteoblast lining the cut edge of the bone and of osteocytes within the harvested bone. A study
that examined successful bone graft harvested by different methods showed that the number of
osteocytes and vital bone was higher with piezosurgery process than with motorized instruments.
It was reported in histological samples excised with piezoelectric device compared to samples
obtained with saw and bur during otologic surgery that new bone formation was better, more
rapid, and primarily composed by bone with piezosurgery, while after osteotomies with bur and
saw the new tissue presented less healing with the central areas of the osteotomies filled with
non-mineralized fibrovascular tissue (Yaman and Suer, 2004). This healing phenomenon is related
to the fact that the surface of the cut is intact and regular with vital osteocytes. Moreover, the
increase of temperature on the surfaces of the cut was evaluated. With piezoelectric drill no
necrosis was revealed; on the contrary, nucleated osteocytes and a peak in growth factor was
observed already one hour after the operation.
Moreover, ultrasonic stimuli may improve bone healing by promoting cell proliferation and
migration. Important for this application, the availability of different piezosurgery tips allows to
modify the harvested bone and sharp it to fit accurately to the recipient (Thomas et al., 2017).

On the other hand, few limitations of piezosurgery have been reported. A proper surgeon
training is necessary since the surgical handling required is completely different from that used
with drills and saws and it is important to use the correct pressure to achieve the desired results.
Pressure of the hand should not be increased (as with drills or saws), since, above certain limits, an
increase in pressure prevents the microvibration of the insert: the energy not used for cutting the
mineralized structures is dispersed as heat leading to necrosis of the bone itself and the
surrounding soft tissues. Indeed, in the case of an eventual contact with soft tissue, the procedure
should be immediately interrupted, in order to avoid unnecessary heat on the soft tissue (Crosetti
et al., 2009).
To now, the lack of insert of appropriate length and thickness makes difficult deeper osteotomies
(Thomas et al., 2017).
A slightly longer operating time compared to traditional methods is needed (Thomas et al., 2017).
However, in some surgery’s fields, such as craniotomy, where the surgeon spends time in
preserving soft tissues and the dura mater from damage and in controlling bleeding from
craniotomy’s borders, the overall surgical procedure duration is not significantly longer compared
to traditional techniques (Iacoangeli et al., 2017)

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Medical applications
Many fields of surgery have seen a progressive increase in the use of piezoelectric devices from
dental, oral and maxillofacial to otological surgery, neurosurgery, orthopedic surgery, craniofacial
surgery, plastic and reconstructive surgery, head and neck surgery, ophthalmology, traumatology,
rhinosurgery and hand surgery; all types of surgery have benefited from the ultrasonic technology
(Labanca et al., 2008 and Yaman and Suer, 2013).
Oral and maxillofacial surgery
Piezoelectric effect is largely and routinely used in parodontology and endodontic surgeries,
procedures that require a meticulous preparation of small bones or pieces of tooth. In working
close to the mandibular canal or maxillary sinus, piezosurgery may prevent nerve damage.
Important indications are for sinus lift, bone graft harvesting, osteogenic distraction, ridge
expansion, inferior alveolar nerve decompression, cyst removal, dental extraction unilateral
condylar hyperplasia, root canal fillings, impacted tooth and subgingival plaque removal (La banca
et al., 2008). A review by Thomas et al. reported that piezosurgery reduces the risk of perforating
Schneiderian membrane from 30% to 7% during osteotomy procedures for bone window
confection or during membrane lifting. The results of a study of 17 vertical alveolar distraction in
the posterior region of mandible showed that the surgery was easier and less prone to
complications compared to osteotomy with traditional methods (Thomas et al., 2017).
Piezosurgery has been employed to correct maxillofacial deformities, as reported by Ueki
et al. In their study, where 14 patients were subjected to piezosurgey osteotomy, no damage to
the surrounding tissue was found (Labanca et al., 2008). The group of Dr. Robiony showed that no
signs of necrosis and the vitality of pulpal teeth was maintained in a multiple-piece maxillar
surgery. They also noticed little bleeding and lack of damage to the main vessels (Robiony et al.,
2004 and Robiony et al., 2007). Recently, Etayeb et al. reported a case of a 21 years old female
diagnosed with a hemmandibular hyperplasia that was operated with a piezoelectric device to
split the lower border cortical plate. After the surgery, the alveolar nerve was intact and the
patient did not report any paresthesia within 6 months of follow-up (Etayeb et al., 2017).
Also in orthognathic surgery, the application of piezoelectric devices has gained popularity.
Landes et al. conducted a large study on 90 patients concluding that surgery operating time
remained the same and the amount of blood lost was decreased in the case of Le Fort I
osteotomies compared to conventional methods (Yaman and Suer, 2013).
In rhinoplasty, the osteotomy process needs precision for patient safety. Traditional tools
transmit a great force to the bones and can lacerate the soft nasal tissue and principal vessels.
Robiony et al. demonstrated that the use of piezosurgery instead of the traditional methods can
avoid these problems (Robiony et al., 2007a). Another group, guided by Dr. Salami, conducted a
study on 10 patients evaluating the applicability and the soft tissues safety of piezosurgery in the
resection of nasal malignant tumors through a paralateronasal approach. In all the patients,
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piezosurgery allowed a rapid and easy intraoperative management and a precise and safe cut,
especially in the more difficult anatomical sites, confirming its safety on soft tissues. Also, the
histological examinations carried out on the cut surface revealed the absence of necrosis and the
presence of live osteocytes of normal dimension and morphology (Salami et al., 2008).
Implantology
Piezosurgery provides high precision and operating sensitivity while harvesting block graft (Yaman
and Suer, 2013). Moreover, it decreases the risk of bone fracture, minimizing complications. In
implantology it is used for split-crest bone procedures and to perform bone augmentation by
autologous bone harvesting, as well as to prepare bone to receive dental implants, without the
risk of bone thermal necrosis and a reduced risk to damage the adjacent soft tissues (Thomas et
al., 2017).
Otological surgery
In otological surgery various operations like stapedotomy, antrotomy, mastoidectomy of the intact
canal wall, posterior tympanotomy, decompression of the facial nerve, and excision of a glomus
tumor of the middle ear can be performed using piezoelectric devices allowing rapid and easy
intraoperative management as well as a precise cutting.
Head and neck surgery
The use of piezosurgery in head and neck oncological and reconstructive surgery has been
developed in 2002-2006. Crosetti et al., published a paper regarding their experience in 127
patients using piezosurgery. Boccupharyngectomy by demolitive and conservative
transmandibular approaches were performed in 33 and 44 patients respectively. In all the cases,
the cutting line was clean and precise with a complete preservation of vessels. In the demolitive
transmandibular approach, the piezoelectric method was also used for harvesting the flap for the
reconstruction with fibula free flap. The safety of this devise was confirmed by the surgeons. In 15
patient presenting frontal sinus diseases piezoelectric surgery was used to prepare the bone
operculum access to the frontal sinus, following preparation of the bicoronal flap. Also in this case,
the procedures were conducted with great precision on the shape of the sinus (Crosetti et al.,
2009).
Neurosurgery, Craniofacial and spinal surgery
One of the major problem in neurosurgery is how to perform a rapid and effective skull opening
without damaging the dura mater and causing the development of a fistula of cerebrospinal fluid.
Oscillating saws are extremely efficient in skull penetration but can also be destructive on the
craniotomy’s borders and can be dangerous on the non-osseous structures. These limitations
become evident especially in the case where craniotomy is performed in area with minimal bone
width and abundant soft tissues, like the orbit. Therefore, craniotomy, orbitotomy, and posterior
spinal laminotomy have been successfully completed using piezoelectric devices (Labanca et al.,
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2008). In a case report a 45 years old woman presenting a left supero-lateral orbital lesion was
treated with a piezoelectric scalpel to perform a left lateral orbitotomy. The new tool allowed an
excellent maneuverability during the surgery and a precise osteotomy, facilitating craniotomy’s
borders ossification and avoiding damage to the soft tissues (Iacoangeli et al., 2017).
Neurosurgical procedure in the cranial base and spine has been performed in children using
piezoelectric devices. A report published in 2005 demonstrated and introduced for the first time
the utility of piezoelectric bone surgery in cranial base and spinal surgery in children between the
age of 6 and 84 months operated for craniosynostosis, tethered cord, and an extraconal
intraorbital tumor (Schaller et al., 2005). Shaller et al. reported that the technique spared soft
nerve tissue, avoided coagulative necrosis, improved the visibility of the surgical area and resulted
in a more precise cut compared to traditional oscillating saw. Until then, there was no
documented neurosurgical experience of this technique even in adults. The application of the
piezosurgery devicecan be useful in children because of poor intraoperative visibility, the presence
of delicate anatomic structures and because they have low circulating blood volumes and
piezosurgery prevents blood loss during the surgery become necessary. Chaichana et al. reported
positive results in a group of 13 infants (average age was 11.8 weeks) that underwent to a metopic
synostosis (4 patients) or a sagittal synostosis (9 patients), showing that the piezoelectric device
limited blood loss (Chaichana et al., 2013). Ramieri et al. created a study group selecting all the
patients between 3 months and 1 year of age who underwent a surgical correction of craniofacial
deformities in the university of Rome “La Sapienza” and were operated with piezoelectric
instruments. This group was compared with a group of similar size and range of age and who
underwent the same kind of operations but with traditional tools. In both groups there were
patients who had scaphocephaly, trigonocephaly and left anterior synostotic plagiocephaly. In all
the operations using piezosurgery, the surgeons had a greater sensitivity and precision in cut. The
pediatric blood bags used for patients operated with piezosurgery were half compared to the
control group. Also, there was no injury to the dura mater and a better postoperative bone healing
was observed with piezosurgery device (Ramieri et al., 2015). Another study performed a
comparison between the traditional saw and the piezoelectric device in 13 pediatric patients
underwent craniofacial osteotomies. The saw was used on one side and the piezoelectric device in
the other size of the patients. They found an intraoperative blood loss reduction, a greater
precision in bone cutting, a significant reduction in nerve impairment and a lower incidence of
postoperative haematoma and swelling following piezosurgery (Spinelli et al., 2015).
Orthopedics and Hand surgery
In orthopedic surgery, piezoelectric devices allow a safer, more precise and effective bone cutting
(Labanca et al., 2008). However, it has been reported in a study that the system was less efficient
for deep cuts and it was necessary to pause the system and allow it to cool down. In hand surgery,
nerve injuries are feared complications with the use of standard oscillating saw. A faster recovery
was obtained through piezoelectric applications compared to traditional rotating or hand tools
and the cutting was precise with no microvibrations, which may cause nerve lesions. Another
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study showed the precision and ability to protect soft tissue when major thickness bones
(metacarpal, fibula and rib) are cut.

Removal of bone cement


Poly(methylmethacrylate) (PMMA)-based bone cement, commonly known as acrylic bone cement
is a polymer primarily employed in arthroplasty to fix the joint replacement prosthesis to the
periprosthetic bone tissue. Created by Otto Röhm at the beginning of the 19th century and then
refined by two companies, Kulzer and Degussa in 1943, into its dough-like form, PMMA is a self-
curing polymer. Their developments led to the introduction of cold-cured PMMA, which hardens
at room temperature (Magnan et al., 2013). Although invented by Otto Röhm, PMMA’s success
and its popularity in orthopaedics is attributable to Sir John Charnley, a British surgeon whose
work and research brought, in 1960, to the introduction of acrylic bone cement in arthroplasties.
From its first biomedical application as a material intended to produce dentures, acrylic bone
cement has evolved; its main function is in arthroplasty to stably fix joint replacement to the bone.
Modern acrylic bone cements consist of two phases: a solid one made by a polymer powder
constituting the catalyst, and an added radio-opacifier, usually barium sulfate or zirconium
dioxide, while the liquid phase contains the monomeric form of methylmethacrylate and a
stabilizer. The two phases are mixed in the operating room until they become dough-like and are
then applied to the bone prior to insertion of the component of the joint replacement prosthesis
(Magnan et al., 2013). During polymerization, self-curing PMMA releases energy by means of an
exothermic reaction. The heat production has been studied in-vitro and in-vivo. In in-vitro, heat
release is directly influenced by the cement mantle thickness, the ambient temperature and the
ratio monomer/polymer (the higher the amount of the monomeric liquid form, the higher the
curing temperature), and it varies between 70° and 120 °C; while in vivo temperature raises
between 40°C and 56°C therefore avoiding collagen denaturation and potential osteonecrosis.
Often applied in a solid to liquid 2:1 ratio the mixture hardens in short period of time that varies
from 10 to 20 minutes. The acrylic bone cement serves different functions; its primary one being
fastening orthopedic implants in arthroplasty.

After more than 50 years from its introduction, bone cement is still the only material used
for prosthesis fixation. In vertebroplasty PMMA is used to treat vertebral fractures; it is injected
into the vertebrae usually through the vertebral pedicles or, during the execution of kyphoplasty,
to fill the cavity produced by an inflated balloon pushed inside the vertebrae to lift the fractured
and depressed vertebral body. Bone cements can function as a matrix for the local application of
antibiotics. Supplementing the bone acrylic cement with additives, such as powders of antibiotics
like gentamicin, function as drug delivery system especially in case of infection (infection as an
incidence between 0.5 and 3 % in primary hip and knee prosthesis and a higher incidence in the
case of revision procedure) when prosthetic implant integrity declines overtime up to the point in
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which a replacement procedure is needed or when the insertion of an antibiotic-loaded cement
spacer is required before prosthetic replanting to maintain an effective antibiotic concentration.
Fractures of the proximal third of the femur or in osteoporotic pertrochanteric unstable fractures
of the elderly, can be fixed with bone cement used as augmentation support in the internal
fixation of these fractures. Few but serious adverse effects are associated with PMMA such as
arterial hypotension, oxygen desaturation, arrhythmia, embolization of marrow debris and
neurogenic reflex, and death due to monomer toxicity or anaphylaxis (Magnan et al., 2013).

Clinical settings where bone cement removal is required


Demand for arthroplasties has drastically increased in recent years and is projected to rise even
further to 511,837 primary hip and 1,375,574 primary knee arthroplasties by 2030. Similarly, other
types of arthroplasties including shoulder and elbow have also experienced upwards trends. And
so failure rates rise of 1% per year (Saleh et al., 2016). Total joints replacement enables people to
get rid of pain and regain independence. Over time, however, the hardware used in replacement
arthroplasty can fail for a variety of reasons. When this occurs, a second surgery, namely a revision
arthoplasty, is performed to remove some or all of the parts of the original prosthesis and replace
them with new ones.

Revision Total Hip Replacements


Total hip replacement implants typically consist of the acetabular component (which is fitted into
the patient’s native acetabular pelvic bone with or without cement), the femoral component
(inserted down the femoral canal), and the bearing surfaces (the articulating aspects of the
implant). Although most total hip replacements are very successful, problems can develop over
time. During total hip revision arthroplasty the failing prosthesis is replaced with a new implant. It
has been suggested that cemented steam has a shorter life span compared to cementless implants
and that total hip arthroplasty in age younger than 65 years and male gender were predictors of
revision surgery (Kristoff Corten et al., 2010). The literature, however, is inconclusive on whether
cemented or cementless fixation technique is superior, and choice of fixation type is mainly
determined by surgeon preference and experience (Saleh et al., 2016). In the event of revision
prosthesis, the surgeon’s approach should be selected with care to determine the optimal strategy
in order to anticipate and to prevent complications. Lafosse et al. suggested two major instances
for a revision to be considered: planned and unplanned revision. Planned femoral revision is
considered an option when there is breakage of the stem or neck, or when patients carry chronic
infection and the stem and all the cement must be thoroughly removed and also in the presence
of femoral osteolysis, during cup revision.
On the other hand, unplanned femoral revision can be the choice intraoperatively when, during a
planned cup revision a lower-limb length proves impossible to adjust or in presence of instability
that cannot be managed differently (e.g. with different hardware choices); if there is head-cup

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incompatibility, or when the stem gets damaged (Laffosse et al., 2016). If the result of a fall is a
periprosthetic fracture then, also in this case, revision surgery is required.

In hip prosthesis, femoral stem extraction is challenging. A study of 1398 femoral revisions
showed intraoperative fractures in 12% and cortex perforation in 5% of cases. (Laffosse et al.,
2016). In general the stem of the prosthetic implant is easily removed, particularly if it has a
smooth surface. The main challenge resides in removing the cement and plug during which several
complications may arise including perforations, fractures, and incomplete cement removal
responsible for further bone damages that may compromise the implantation of the new femoral
component (Laffosse et al., 2016). Removal of cemented prosthesis needs a thorough and efficient
disposal of the cement material used. Cement removal can be performed using various
instruments, usually chisels and drills, curettes or motors driven tools characterized by a very high
rotational speed. However, these methods are time consuming and technically difficult, with high
risk of bone perforation and bone loss. Another method for removing old cement consists in the
Segmental Cement Extraction System. With this method, a threaded rod is cemented into the
cement mantle; all the components of the system and the cement are then extracted as a single
unit tapping gently to a slap hammer attached to the rod (Ekelund et al., 1992). Mechanical
cement removal techniques have high incidence of complication due to perforation and fracture
reported as high as 13%.

Ultrasound application can be used for cement removal; the energy generated by the
instrument’s tip heats the cement, thereby causing it to disintegrate. Considerably lower incidence
of bone damage is found when ultrasound is employed. Three separate studies reported the
following cortical perforation rates: 3 out of 90 cases by one study, none out of 20 in the second
and 1 in 48 from revision hip arthroplasties (Goldberg et al, 2008).
After a cemented primary fixation, thorough removal of old cement is essential for femoral
revision but it might lead to further bone loss and consequently inadequate fixation of the
subsequent revision stem. Femoral impaction allografting has been widely used in revision surgery
for the acetabulum, and subsequently for the femur. Impacted morsellized bone graft are
incorporated by the host skeleton therefore creating a new endosteal surface. Impaction grafting
might technically be more challenging and time consuming than cementless fixation techniques,
however it enables a reliable restoration of bone stock especially important if further revision is
planned (Gehrke et al., 2013).

Revision Total Knee Arthroplasty


During primary total knee replacement, the knee joint is replaced with an implant, or prosthesis,
made of metal and plastic components. Revisions for total knee arthroplasty pose unique
challenges as revision surgery is a more complex surgery than a primary total knee arthroplasty,
with increased complication and mortality rates. Total knee arthroplasty is primarily related to

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population aging, obesity epidemic and to technical advancement of the surgical procedure.
Significant demand for primary total knee arthroplasty corresponds to a growing demand for
revisions of total knee arthroplasty which are projected to increase by 601% from 2005 to 2030
(Jasper at al., 2016). The longevity of implants is typically greater than 10 years with 32,700
revisions performed annually in the USA. Literature reports that revision rates for total knee
arthroplasty decrease when the primary surgery is performed in older age population while the
risk for a subsequent revision increases in younger population. However, the latter factor must be
further examined to determine if it is indeed age that is the risk factor or if age is a proxy for
higher activity levels or increased expectations in this younger patient population (Jasper at al.,
2016).
Main causes for total knee arthroplasty revisions are implant loosening and wear,
infections, instability and periprosthetic fracture. Joint implant factors such as fixation, patellar
resurfacing and alignment influence the incidence of revision in total knee arthroplasty. It has
been found that cemented primary total knee arthroplasty had a protective effect on receiving
revision as compared to cementless/hybrid total knee arthroplasties from 9337 patients combined
data from two different studies done in the US. Hybrid fixation, in which the proximal component
was cementless and the distal component was cemented, also demonstrated a higher risk for
revision than cemented total knee arthroplasties in both US and Norwegian studies (Jasper at al.,
2016). Furthermore, demographic factors like age, race and sex and medical conditions such as
arthritis and implant factors were identified as risk factors for revision of TKA when they were
established as the cause for the primary arthroplasty. Indeed, it has been found that African
American patients also had a higher risk for revision than Caucasian patients. Also, medical risk
factors including three types of arthritis - osteoarthritis, rheumatoid arthritis and post-traumatic
arthritis - are demonstrated to increase risk for a revision. A clinical study of 4743 patients found
that osteoarthritis or post-traumatic arthritis had a greater risk of revision than rheumatoid
arthritis. This is however in contrast with studies conducted in a clinical sample of 14352 patients
by Kreder et al. that reported no significant association between the diagnosis of osteoarthritis
and risk for revision (Kreder et al., 2003).
Cemented total knee arthroplasty has greater fixation and survivorship than cementless
total knee arthroplasty. The Swedish Knee Arthroplasty Registry and the New Zealand Joint
Registry reported a higher risk of revision after total knee arthroplasty due to loosening of the
tibial component. A recent study reported the need for revision due to an early failure in more
than 8% of patients with the uncemented tibial component at 18 months after total knee
arthroplasty (Meneghini et al., 2013). Also, a smaller migration of prostheses was shown to be
significantly associated with uncemented tibial components compared to cemented ones.
Contrasting finding are reported in a recent study where Park et al. showed that survival rates
were similar: 100% for cemented tibial, femoral, and cementless femoral components, and 98%
for cementless tibial component (Park et al., 2011). Thus, no consensus exists in the literature
regarding which type of fixation, cemented or uncemented, is superior in total knee arthroplasty.

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Literature and national registries supports the use of cementless fixation in young people since
they will eventually require revision (Saleh et al., 2016).

Revision Total Shoulder Arthroscopy


Loosening of the humeral component in shoulder arthroplasty is rare. However, there are a
number of indications for removal of a humeral stem. Usually, well fixed stem either with cement
or bone on-growth can be difficult to be removed since the extraction process can significantly
damage the humerus and be highly destructive to the proximal humeral bone stock. The most
common reasons for a revision of a total shoulder arthroplasty are a failed primary total
arthroplasty or a failed hemiarthroplasty to a reverse total shoulder arthroplasty (Wright et al.,
2013).
Recent studies reported superior outcomes in the usage of cemented compared to
uncemented total shoulder arthroplasty. A double-blind study conducted by Boileau et al., in
which 39 patients with primary osteoarthritis were randomized to receive either a cemented
glenoid component or a cementless one at the time of total shoulder arthroplasty, reported that
the survival rate of cementless glenoid components is inferior to cemented components (Boileau
et al., 2002). Consistently, another study on 124 patients followed-up at an average of 7.5 years
found a higher failure rates after uncemented glenoid component implant (Saleh et al., 2016).
Furthermore, a recent study looked at reverse shoulder arthroplasty with 2-year follow-up.
Although both uncemented and cemented cohorts had insignificant differences in functional
scores, the authors stated that uncemented fixation may provide several benefits over cemented
fixation with advantages such as simplified operative technique, no cement-related complications,
greater ease of revision, and long-lasting biologic fixation (Wiater et al., 2014).
The most common complication with all revision surgeries is infection. Infection poses a
challenge since the entire infected area has to be cleared: all the hardware must be removed and
all the cement thoroughly disposed of. Other complications include loosening of the implant,
periprosthetic fracture, and nerve injury (radial nerve or brachial plexus) (Wright et al., 2013).
After humeral stem removal, in cemented cases, all loose cement is removed and a vascularized
door would be preferred and can easily be the second stage of the episiotomy. If only partial
cement removal is required, the episiotomy approach is less destructive.

Ultrasonic cement removal


Removal of cemented prosthesis needs a thorough and efficient disposal of the cement material
used. Cement removal can be performed using various instruments including conventional
manual cement removal tools such as drills, burs, curettes, and flexible osteotomes or power-
driven ones. The usage of these tools can be time consuming, technically difficult, with high risk of
bone perforation and fracture, and bone loss. Straight slender chisels are used to split large
fragment of cement longitudinally; during this phase fracture and mostly distal cortical perforation
are a danger. Finally, the plug is removed using drill bits and powered reamers; visual control,

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which is necessary, is facilitated by lighting the site and by a continuous lavage and aspiration.
Hooks and curettes provide the tactile probing to ensure a thorough removal.
Prosthesis revision surgery uses ultrasonic instruments for cement removal in alternative
or in combination with manual tools. Ultrasonic devices offer an alternative method of cement
removal, converting ultrasound into vibrational energy which is in turn transmitted by a probe to
the cement. In this case the smart design of the probe enhances friction causing a temperature
raise and therefore cement melting. The heat is preferentially absorbed by the
polymethylmethacrylate (PMMA} due to its high capacity for energy absorption and a low thermal
conductivity. Also, the thermal conductivity of each material influences heat production. For
instance, PMMA, bone, muscle and nerve have different thermal conductivity and became heated
to different degrees when touched with the ultrasound device. This facilitates selective cement
removal, preserves bone, decreases cortical perforation risk, and eliminates the need for
osteotomy (Lafosse et al., 2016). However, a temperature spike could result in thermal injury and
a slow, gradual progression is required to avoid thermal spikes and probe stalling inside the
cement plug. In general, the operative techniques adopted by each individual surgeon may also
influences heat production; continuous bursts of energy lead to higher temperature than pulsed
bursts. In addition, a higher power setting changing of the ultrasound device parameters increases
the amplitude of the sound waves and produces greater heat as well as the ultrasonic tip with
higher surface area results in increased frictional heat generation (Goldberg et al., 2008).
Damages caused by thermal exposure depend also on the specific cell type. Endothelial cells die at
70°C for few seconds while cellular necrosis occurs in bone tissue after 60 seconds exposure at
47°C, the same heating temperature and time in nerve tissue caused permanent physiological
damages while at 58°C we assist to axonal complete degeneration (Goldberg et al., 2008). In
canine models, less osteonecrosis was seen when cement was removed by ultrasound compared
to high speed burs. Moreover, the comparison group of dogs from which cement was removed by
mechanical devices showed a predominant osteoclastic response and minimal bone formation.
However, during total elbow arthroplasty revision temperature rising linked to ultrasonic melting
and removal of cement were measured at the level of humerus, triceps and radial nerve. A
Significant temperature increase was recorded compared to the one recorded during cement
polymerization’s phase (Goldberg et al., 2008).

As already mentioned, mechanical cement removal techniques have high incidence of


complication due to perforation and fracture reported. Considerably lower incidence is found
when ultrasound is employed. Three separated studies reported the following cortical perforation
rates: 3 out of 90 cases by one study and 1 in 48 in a second study where patients underwent to
hip arthroplasties, and none out of 20 in a third study where patients underwent to revision joint
arthroplasty (Gardiner et al., 1993, Klapper et al., 1992 and Brooks et al., 1995). The same studies
also demonstrated that ultrasonic tools allow more rapid completion of cement and prosthesis
removal than traditional manual tools. Moreover, Klapper et al. produced data using an in vivo
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canine model demonstrating the efficacy of ultrasound to preserve the safety of the endosteal
bone where cement had been removed (Klapper et al., 1992). In shoulder arthroplasty, the
ultrasonic device can be very helpful for removing the distal cement in a tapered humeral canal.
During humeral arthroplasties, however, care should be taken with the extensive use of these
devices. Since they generate heat and require frequent injection for cooling. Radial nerve injuries
have been reported with their use even in the absence of perforations (Wrigth et al., 2013).
Other benefit showed by ultrasound devices is to provide the surgeon with a major tactile
and auditory feedback compared to manual cement extraction with hand and powered tools. This
is due to bone and cement different acoustic reaction to vibration and visual aid due to smoke or
smokeless operation (smoke is produced when the ultrasound device contacts cement) (Goldberg
et al., 2008).

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References
Boileau P, Avidor C, Krishnan SG. Cemented polyethylene versus uncemented metal-backed
glenoid components in total shoulder arthroplasty: a prospective, double-blind, randomized
study. J Shoulder Elbow Surg. 2002; 11: 351–359.

Brooks AT, Nelson CL, Hofmann OE. Minimal femoral cortical thickness necessary to prevent
perforation by ultrasonic tools in joint revision surgery. J Arthroplasty. 1995; 10:359-362

Chaichana KL, Jallo GI, Dorafshar AH, Ahn ES. Novel use of a n ultrasonic bone-cutting device
for endoscopic-assisted craniosynostosis surgery. Chids Nerv Syst. 2013.

Corten K., Bourne R.B., Charron K.D., Au K., Rorabeck C.H. What works best, a cemented or a
cementless primary total hip arthroplasty? Minimum 17- follow up over randomized controlled
trial. Clin Orthop Relat Res. 2011;469:209-17

Crosetti E., Battiston B., Succo G. Piezosurgery in head and neck oncological and reconstructive
surgery:personal experience on 127 cases. Acta Otorhinolaryngol Ital. 2009;29:1-9.

Douglas L. Miller, Nadine B. Smith, Michael R. Bailey, Gregory J. Czarnota, Kullervo Hynynen,
Inder Raj S. Makin. Overview of Therapeutic Ultrasound Applications and Safety
Considerations. J Ultrasound Med. 2012;31:623-634.

Ekelund A.L. Cement removal in revision hip arthroplasty. Experience with bone cement added
to the cavity in 20 cases. Acta Orthop Scand. 1992; 63: 549-551.

Etayeb A.S., Ahmad A.G. Piezosurgery: A safe technique for inferior alveolar nerve mobilization
in surgical correction of hemimandibular hyperplasia-Review of the literature and case report.
In J of Surgery Case Reports. 2016.

Eriksson AR, Albrektsson T, Albrektsson B. Heat caused by drilling cortical bone. Temperature
measured in vivo in patients and animals. ActaOrthop Scand. 1984;55:629-31.

Gardiner R, Hozack WJ, Nelson C, Keating EM. Revision total hip arthroplasty using
ultrasonically driven tools. A clinical evaluation. J Arthroplasty. 1993;8:517-21.

Goldberg SH, Studders EM, Cohen MS. Ultrasonic cement removal in revision arthroplasty.
Orthopedics. 2007;30:632-5

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Gehrke T, Gebauer M, Kendoff D. Femoral stem impaction grafting: extending the role of
cement. Bone Joint J. 2013;95-B(11 Suppl A):92-4.

Iacoangeli M., Neri P., Balercia P., Lupi e., Di Rienzo A., Nocchi N., Alvaro L., Scerrati M.
Piezosurgery for osteotomies in orbital surgery: our experience and review of the literature. In
J of Surgery Case Report. 2013: 188-191.

Jasper L.L., C. A. Jones, J. Mollins, S. L. Pohar and L. A. Beaupre. Risk factors for revision of total
knee arthroplasty: a scoping review. BMC Musculoskeletal Disorders. 2016;17:182.

Klapper RC, Caillouette JT, Callaghan JJ, Hozack WJ. Ultrasonic technology in revision joint
arthroplasty. Clin Orthop Relat Res. 1992;285:147-54.

Kreder HJ, Grosso P, Williams JI, Jaglal S, Axcell T, Wai EK, et al. Provider volume and other
predictors of outcome after total knee arthroplasty: a population study in Ontario. Can J Surg.
2003;46:15–22.

Labanca M, Azzola F, Vinci R, Rodella LF. Piezoelectric surgery: twenty years of use. Br J Oral,
2008.

Laffosse JM. Removal of well-fixed fixed femoral stems. Orthop Traumatol Surg Res.
2016;102(1 Suppl):S177-87.

Magnan B, Bondi M, Maluta T, Samaila E, Schirru L, Dall’Oca C. Acrylic bone cement: current
concept review. Musculoskelet Surg. 2013;97:93–100.

Marco M, Rodríguez-Millán M, Santiuste C, Giner E, Henar Miguélez M. A review on recent


advances in numerical modelling of bone cutting. J Mech Behav Biomed Mater. 2015
Apr;44:179-201.

Meneghini RM, de Beaubien BC. Early failure of cementless porous tantalum monoblock tibial
components. J Arthroplasty. 2013;28:1505–1508

Park JW, Kim YH. Simultaneous cemented and cementless total knee replacement in the same
patients: a prospective comparison of long-term outcomes using an identical design of NexGen
prosthesis. J Bone Joint Surg Br. 2011;93:1479–1486.

Ramieri V, Saponaro G, lenzi J, caporlingua F, Polimeni A, Silvestri A, pizzuti A, Roggini M,


Tarani L, Papoff P, Giancotti A, Castori M, Manganaro L, Piero C. The use of piezosurgery in
cranial surgery in children. The j of craniofacial surgery. 2015.

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Robiony M, Polini F, Costa F, Vercellotti T, Politi M. Piezoelectronic bone cutting in multipiece
maxillary osteotomies. Int J Oral Maxillofac Surg 2004;62:759-61.

Robiony M, Polini F, Costa F, Toro C, Politi M. Ultrasound piezoelectric vibrations to perform


osteotomies in rhinoplasty. Int J Oral Maxillofac Surg 2007a; 65:1035-8.

Robiony M, Polini F, Costa F, Zerman N, Politi M. Ultrasonic bone cutting for surgically assisted
rapid maxillary expansion (SARME) under local anaesthesia. Int J Oral Maxillofac Surg
2007b;36:267-9.

Salami A., Dellepiane M., Crippa B., Mora R., A new method for osteotomies in oncologic nasal
surgery: Piezosurgery. American journal of Otolaryngology-Head and nack medicine and
surgery 2010.

Saleh KJ, El Othmani MM, Tzeng TH, Mihalko WM, Chambers MC, Grupp TM. Acrylic bone
cement in total joint arthroplasty: A review. J Orthop Res. 2016;34:737-44.

Schaeren S, Jaquiery C, Habere M, Tolnay M, Vercellotti T, Martin I. Assesment of nerve


damage using a novel ultrasonic device for bone cutting. J Oral Maxillofac Surg. 2008;66:593-6.

Schaller BJ, Gruber R, Merten HA, Kruschat T, Schliephake H, Buchfelder M, Ludwig HC.
Piezoelectric Bone Surgery: A Revolutionary Technique for Minimally Invasive Surgery in
Cranial Base and Spinal Surgery? Technical Note. Neurosurgery. 2005; 57(4 Suppl):E410.

Spinelli G, Mannelli G, Zhang YX, Lazzeri D, Spacca B, Genitori L, Raffaini M, Agostini T. Complex
craniofacial advancement in pediatric patients: piezoelectric and traditional technique
evaluation. J of Crani-Maxillo-facial surgery. 2015;43:1422-7.

Thomas M, Akula U, Ealla KK, Gajjada N. Piezosurgery: A Boon for Modern Periodontics. J Int
Soc Prev Community Dent. 2017;7:1-7.

Wiater JM, Moravek JE, Jr., Budge MD, et al. Clinical and radiographic results of cementless
reverse total shoulder arthroplasty: a comparative study with 2 to 5 years of follow-up. J
Shoulder Elbow Surg. 2014;23:1208–1214.

Wright T.W. Revision of Humeral Components in Shoulder Arthroplasty. Bulletin of the


Hospital for Joint Diseases 2013;71(Suppl 2):S77-81

Yaman Z. and Suer B.T. Piezoelectric surgery in oral and maxillofacial surgery. Annals of oral &
maxillofacial surgery. 2013;1:5.

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5. AIM OF THE CLINICAL EVALUATION: ESSENTIAL REQUIREMENTS, CLINICAL RISKS AND


PRODUCT CLAIMS (STAGE 0)

The aim of this clinical evaluation is that of assessing:

a) if the 93/42/EEC Medical Device Directive (MDD, as amended) Essential Requirements


(ERs) concerning the performance, safety, risk/benefit profile and acceptability of side
effects of the MJ-FLEX device are met. Specifically, the following ERs were considered:

Requirements on safety and on the benefit/risk profile (MDD ER1)

1. The devices must be designed and manufactured in such a way that,


when used under the conditions and for the purposes intended, they
will not compromise the clinical condition or the safety of patients, or
the safety and health of users or, where applicable, other persons,
provided that any risks which may be associated with their intended
use constitute acceptable risks when weighed against the benefits to the
patient and are compatible with a high level of protection of health and
safety. (…)

Requirement on performance (MDD ER3)

3. The devices must achieve the performances intended by the manufacturer


and be designed, manufactured and packaged in such a way
that they are suitable for one or more of the functions referred to in
Article 1 (2) (a), as specified by the manufacturer.

Requirement on acceptability of side-effects (MDD ER6)

6. Any undesirable side-effect must constitute an acceptable risk when


weighed against the performances intended.

b) if the Oscar device actually provides the intended performance and the intended clinical
benefits.

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The claims were identified by screening the information available online on the Orthofix
website [http://web.orthofix.com/Products/Pages/OSCAR3-Lower.aspx; accessed on
26/07/2017] and by screening the product literature (Operative Technique Version OS-
1501-OPT-E0 B 01/16, and commercial brochures Version OS-1601-PL-E0 A 12/16 and OS-
1502-PL-E0 C 09/16) and the instructions for use (Version PQ OSC B 02/17). These
documents are available in Annex B. The claims can be summarized as follows:

-Efficient performance: designed to reduce manual force.


-The performance is reproducible.
-The equipment is simple to operate.
-Versatile: single use probes for both cement and prosthesis removal.
-Safe: designed to minimize accidental bone damage.

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6. CHOICE OF DATA TYPES

This Clinical Evaluation was performed through a compilation of relevant published scientific
literature and subsequent critical evaluation of this compilation (literature route). Literature
include clinical data on the device concerned and on equivalent devices already on the market.
Analysis of equivalence between the Oscar device and the equivalent devices was therefore
requested.
Details about the assessment of equivalence, and its justification, are provided in Section 8 and in
the Literature Search Report (Annex B). Technical details about these devices are provided as an
attachment (see Annex B).
Data assessed were only those describing the clinical applications of devices equivalent to the
Oscar device and the consequent outcomes in term of performance and safety. Criteria applied to
perform the literature search to identify this kind of data only (i.e., clinical data) are provided in the
Clinical Evaluation Plan (Annex A).

7. METHODOLOGY (STAGE 0 and 1)

This Clinical Evaluation was conducted according to a well-defined and methodological procedure
detailed in the Clinical Evaluation Plan (Annex A).

In summary:

The Clinical Evaluation Plan was prepared before performing any literature search. It describes how
the literature search was planned.

- Evaluation of equivalence: The evaluation of equivalence between the Oscar device and a
candidate equivalent device was performed by comparing the key characteristics of the two
devices, with the aid of a Product Comparison Form. Characteristics subjected to comparison were
a) Clinical; b) Technical; c) Biological. The following clinical characteristics were compared: 1) the
clinical condition/purpose/indication; 2) the site of application to/in the body; 3) the patient
population. Technical characteristics undergoing comparison were 1) the conditions of use; 2) the
device specifications and properties; 3) the device design; 4) the principles of the device operative
technique. As far as the biological characteristics were compared, an analysis of the materials of
the two devices in contact with the same body fluids/tissues was carried out.

- Identification of appropriate data and documents (search strategy): the literature search was
performed searching the PubMed database. The PubMed database was selected because it collects
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data stored in the Medline journal citation database of the US National Library of Medicine,
concerning more than 22 million biomedical publications, together with in-process citations,
“ahead of print” citations, and citations for books available on the US National Center for
Biotechnological Information (NCBI). Articles retrieved by using PubMed are all published in
international well-known, peer-reviewed scientific journals dealing with all aspects of trauma and
orthopedic surgery and most of them having an impact factor. The studies accepted in such
journals are generally performed according to established scientific guidelines, characterized by an
appropriate design and unbiased measurements of outcome, and conducted after ethical
committee approvals. Finally, the peer-review process guarantees high scientific level, improves
performance and provides credibility and independence from biased and influenced evaluations.

The search aimed to:

1) Identify and retrieve papers detailing clinical investigation (i.e. investigations on human
subjects) whose aim was specifically to assess the effectiveness and safety of the Oscar/an
equivalent device.
2) Identify and retrieve papers detailing clinical investigations (i.e. investigations on human
subjects) with different aims than above, but testifying about the use of the Oscar/an equivalent
device.
3) Identify and retrieve papers detailing cadaver investigations aimed to assess the safety of
the Oscar/an equivalent device.

a) Concerning aim no. 1), the PubMed database was searched for a list of 71 search strings.
Details of each search are provided in the Literature Search Report (Annex B).
This search was limited to papers published from 1992 onward, as one of the equivalent devices
was first placed on the market in 1992 (Oscar was first placed on the market in 1996).

- additionally, the websites of the manufacturers of the equivalent devices were visited to
collect information about the existence of publications of interests. If useful information was
present, (for example, as the complete paper or as a list of publications), the publications were
either downloaded from the manufacturer’s website or searched for in the PubMed database.

- additionally, a heuristic search was performed for further publications: as papers were
found according to the selection criteria for evaluation, a further search was performed to assess if
their authors, while working at the same clinical/research facility, published further papers
describing the use of the Oscar device or of the equivalent/substantially equivalent devices. This
search was performed under the rationale that those authors had the devices of interest available
at their centers, and could have used them for further studies.

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b) Concerning aim no 2), and for the intended use “bone cement removal”, all clinical
publications concerning hip arthroplasty revisions published from January 2006 onward (i.e. on the
last 9.5 years) were searched for, retrieved if available, and it was assessed if any of them
documented the use of the Oscar device, or of any of the equivalent devices. The choice of limiting
the search to hip revisions was dictated by the fact that hip arthroplasty revisions surgeries amount
to the greatest part of revisions surgeries performed.

c) Concerning aim no 3) a search containing specific keywords, including the keyword


“Cadaver” was performed. More details are provided in Annex B.

Inclusion/exclusion criteria

Literature which met the following criteria was excluded from review:
- pertaining to fields other than Orthopedics, Hand&Foot Surgery, Neurosurgery
- reviews, notes, editorials with no clinical data
- retrospective analyses of literature data
- retrospective analyses of national registers
- written in languages other than English
- concerning in vitro or animal studies
- concerning non-equivalent devices

Only data which were not excluded and met the following criteria were selected for review:

- The data must relate to the specific characteristics and features of the device
- The data must relate to the same clinical condition or purpose of the device, yet in deviation to
this rule, and concerning the “bone cutting” intended use only, paper detailing the use of devices
equivalent to Oscar for bone cutting in area different than Orthopedics, and specifically
Neurosurgery, ENT, Hand&Foot Surgery were considered as well. Proper justification is provided in
Annex A – Clinical Evaluation Plan. Cadaver studies were considered too as detailed in c).

- The data should be related to use at the same site in the body of the device. Again, in deviation to
this rule, and concerning the “bone cutting” intended use only, paper detailing the use of devices
equivalent to Oscar for bone cutting in area different than Orthopedics, and specifically
Neurosurgery, ENT, Hand&Foot Surgery were considered as well. Proper justification is provided in
Annex A – Clinical Evaluation Plan. Cadaver studies were considered too as detailed in c).
- The data must relate to the same patient population for which the device is intended, with the
exception of deviations mentioned above.
- The data must relate to similar devices. Devices considered to be equivalent will have similar
materials, specifications, properties, surface characteristics, design, deployment methods.

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- The author of any publications should have background and expertise in orthopedics, or in their
respective relevant fields for studies assessed for evaluation in accordance to deviations mentioned
above.
- While, by procedure, data should not go back more than 5 years, older data were included
(starting from 1992 or 2006 according to the search performed) as previously detailed.

- Assessments of documents with defined scores


The Clinical Evaluation Plan gives evidence that the literature search was accurately planned in
order to be systematic, to include all favourable and unfavourable data and to possibly reduce the
risk of bias. This plan also gives evidence that all retrieved articles were subjected to a precise
assessment and that only appropriate documents were included in the Clinical Evaluation Report.

8. SYSTEMATIC SEARCH OUTCOMES AND ASSESSMENT OF DOCUMENTS (STAGE 2)

Systematic search outcomes and assessment of documents are detailed in the Literature Search
Report (Annex B).

In summary:

Evaluation of equivalence: the following devices have been found to be equivalent to the Oscar
device:

- Biomet Ultra-Drive 3
- Mectron Piezosurgery Medical/Flex/Plus (for the “bone cutting” intended use only)
- Misonix Ultrasonic BoneScalpel (for the “bone cutting” intended use only)

- Identification of appropriate data and documents (search strategy):

Proper search strings were built. Search strings comprised different keywords. More specifically,
these were either

- the name of the device (“Oscar” on one of the equivalent devices) alone, even considering
their most probable writing variants, or
- the device name/manufacturer AND the surgical application (for example: “Oscar” and
“arthroplasty revision”), or
- the device name/manufacturer AND the intended use (for example: “Oscar” and “cement
removal”), or
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- the kind of surgery AND the physical operating principle (for example, “revision
arthroplasty” AND “ultrasounds”), or
- the intended use AND the physical operating principle (for example, “cement removal”
AND “ultrasounds”)

The complete list of the single keywords used is as follows:

1. OSCAR
2. OSCAR II
3. OSCAR 3
4. BONECUTTER
5. ORTHOSONICS
6. REVISION ARTHROPLASTY
7. PROSTHESIS REVISION
8. CEMENT REMOVAL
9. BONE CEMENT REMOVAL
10. OSTEOTOME
11. BONE CUTTING
12. PIEZOSURGERY
13. ULTRASOUNDS
14. ULTRASONIC DEVICE
15. ULTRASOUND DEVICE
16. PIEZOELECTRIC
17. CADAVER
18. HIP REVISION

and retrieved the articles listed in the first tab of the Oscar_Literature_Search_Report.xlsx file
attached.

- Assessments of documents with defined scores:

Each document/data identified was recorded and screened rapidly to determine if the article is of
any relevance: inclusion criteria/exclusion criteria were used for screening purposes. Each
document/data accepted was screened in more detail according to Index of the Origin, Index of
the Similarity and Index of the Quality reported in the P.O. 215. Any documents not meeting the
criteria was logged as inappropriate and excluded. Each document/data accepted was then
analyzed and relevant useable data was included in the clinical evaluation.

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Flow chart for the selection of the scientific articles

Identification of potentially relevant literature Identification of potentially relevant literature


according to the inclusion criteria and keywords deriving from previous independent searches N=2
(database search) N=2534

First selection of the articles according to


exclusion criteria N=284 Articles EXCLUDED
N=2252

Evaluation of the literature according to


Io, Is and Iq indices

Articles in the green zone Articles in the yellow zone Articles in the red zone
N=12 N=18 N=0
+ 2 cadaver studies

Articles with Articles without


Io ≥ 6 and Is ≥ 3 Io ≥ 6 and Is ≥ 3
N=18 N=0

Articles INCLUDED N=30 Articles EXCLUDED N=0


+ 2 cadaver studies
+ OSCAR 3 NICE Report

Analysis of the articles with relevant useable data


included in the clinical evaluation

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At the end of this process 33 documents were included in the literature analysis. The complete list
of articles is reported in Annex F “List of publications”.

The systematic search, the assessment of documents and the critical evaluation were performed
by a person suitably qualified in the research field, and reviewed and approved by an expert
knowledgeable in the “state of the art”. Evidence for these statements is attached in Annex C.
Declaration of interests is attached in Annex D.

9. SUMMARY AND ANALYSIS OF PRE-CLINICAL DATA

Several testing and verification have been conducted on OSCAR 3 equipment for the verification of
safety and effectiveness.

SAFETY as per IEC-60601-1


The object of IEC-60601 is to specify basic safety and essential performance requirements and tests
for alarm systems in Medical Electrical Equipment and Medical Electrical Systems and to provide
guidance for their application. This is accomplished by defining alarm categories (priorities) by
degree of urgency, consistent alarm signal and consistent control states and their marking for all
alarm systems.

Oscar 3 has two functionalities: cement remover and osteotomy; according to manufacturer
consideration and power input measures, the cement remover has been considered the worst case
during the tests.

The equipment is tested in intermitted operation mode (Ton=10 seconds, Toff=20 seconds) as per
the following clauses of the standard:
Clause 4.6 - ME Equipment or ME system parts that contact the patient –
Clause 4.8 - Component of ME equipment -
Clause 5.9.1 - Applied Parts –
Clause 6.4 - Method(s) of sterilization –
Clause 7 - ME equipment Identification, marking and documents –
Clause 7.2.12 - Fuses
Clause 9.6.3 - Hand transmitted vibration -
Clause 11.6.7 - Sterilization of ME EQUIPMENT and ME system -
Clause 11.7 - Biocompatibility -
Clause 12.2 - Usability -
Clause 14 – Programmable electrical Medical System (PEMS) -
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Clause 17 - Electromagnetic compatibility –

Additionally, Orthofix S.r.l guarantees the development and postproduction monitoring and
maintenance of software respecting all the requirements listed in the standard IEC 62304:2006.
In detail about the clause 6 (not previously included in IEC 60601-1 evaluation) Orthofix S.r.l has in
place in its Quality Management System specific procedures to properly manage the maintenance
of software post release.
The process is internally managed through an official request (internal procedure PG 600:
Registration of request; Preliminary evaluation; Identification of owner; Feasibility study;
Implementation of modification) that requires an evaluation and feasibility study of request.
In case of decision of implementation of modification, the development of SW modification is
managed with reference to internal procedures (PG 199 and PO 199) for which is required a
formalization of development plan in which all the activities, deliverables, verification and
validation necessary will be formalized.

USABILITY as per IEC-62366


This International Standard specifies a PROCESS for a MANUFACTURER to analyse, specify, develop
and evaluate the USABILITY of a MEDICAL DEVICE as it relates to SAFETY. This USABILITY
ENGINEERING (HUMAN FACTORS ENGINEERING) PROCESS permits the MANUFACTURER to assess
and mitigate RISKS associated with CORRECT USE and USE ERRORS, i.e., NORMAL USE.
Orthofix developed a new document, “Usability Engineering Process for Oscar 2 & Oscar 3” to
describe Usability Specification and Usability Validation. Usability Specification and Usability
Validation have been developed according to IEC/EN 60601-1-6 and IEC/EN 62366.

ULTRASONIC MEASUREMENTS – IEC 61847


This International Standard specifies:
– the essential non-thermal output characteristics of ultrasonic surgical units;
– methods of measurement of these output characteristics;
– those characteristics which should be declared by the manufacturers of such equipment.

Measurements have been done on handsets and applicators of Orthofix Oscar 3, in particular:

Laser Doppler Vibrometry in Air


The scope was to characterize the four handset/applicator combinations of the ultrasound
equipment, operating at the nominal frequency 28 kHz, by means of a Laser Doppler Vibrometer
concerning the following quantities:

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- Tip vibration frequency, ƒr;
- Primary tip vibration excursion, sp,
The measurements have been realized in air, without any load acting on the applicator tip, and
according to the points 6.4.1 and 6.1.2 respectively of the international standard IEC 61847:1998.

Acoustic Measurements in Water


Measurement, using a calibrated hydrophone, of the output characteristic “Derived output”
acoustic power” for an ultrasonic medical equipment Orthofix “Oscar”, based on the requirements
given by clause 6.5.1 of the reference standard IEC 61847:1998.

Electromagnetical Compatibility – IEC 60601-1-2


The need for establishing specific ELECTROMAGNETIC COMPATIBILITY standards for MEDICAL
ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS (referred to as EQUIPMENT and
SYSTEMS, is well recognized.
In particular, the existence of ELECTROMAGNETIC EMISSION standards is essential for the
protection of:
− safety services;
− other EQUIPMENT and SYSTEMS;
− non-medical electrical equipment (e.g. computers);
− telecommunicacons (e.g. radio/TV, telephone, radio-navigation).

As regarding Orthofix OSCAR 3, all testing according to Clause 6.1 (Emissions) and 6.2 (Immunity)
have been conducted:
6.1 Emissions
6.1.1.2 Limits of mains terminal disturbance voltage
Limits for radiated disturbance
6.1.3.1 Harmonic current emissions
6.1.3.2 Voltage fluctuations and flickers
6.2 Immunity
6.2.2 Electrostatic discharges (ESD)
6.2.3 Radiated RF electromagnetic fields
6.2.4 Electrical fast transients and bursts
6.2.5 Surges
6.2.6 Conducted disturbances, induced by RF fields
6.2.7 Voltage dips, interruptions, and variations
6.2.8 Magnetic field

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Sterilization and Packaging
Shipping and gamma sterilization verification testing has been performed to verify that the Oscar
Probes, cleaned according to the applicable procedure and sterilized by means of gamma radiation
25kGy as per the validated process for Orthofix devices, can achieve sterility with a SAL 10-6; and
that the packaging chosen for the Oscar Probes, processed according to Orthofix standard
procedures, is capable of maintaining sterility of the product after shipping. It was also verified if
the components inside the pouches could move or be damaged after shipping activities.
EN 868, ISO 11607, ISO 11737-2 and ASTM F1980 have been used as reference standard for the
evaluation of the results

Biocompatibility
Since the raw materials and processes used to manufacture Oscar probes are equivalent to those
that are commonly used for titanium implants that have a long history of safe use in clinical
applications, and since the Oscar probes are meant instead only for a limited body contact, we may
conclude that no tests are necessary to demonstrate that they are unlikely to cause adverse
reaction after use.
Nevertheless, all the test suggested in Table A.1 of ISO 10993-1 for this category of devices were
taken into account and performed.

Initially, the structural properties have been determined via single cycle bend testing (Ref. 22300-
T02-03-RP, Section IV.a, DMF A.3.7). Once static load deflection data for the plates have been
gathered, M-N curves for the plates have been created based on fatigue test results. The curves
have been used to compare fatigue strength at different fatigue life levels (Ref. 22300-T03-01-RP,
Section IV.a, DMF A.3.7).

The plate with the smallest cross-sectional area was selected to be the worst case plate because it
presents the largest stress that the implants would undergo in a clinical setting. As described
previously, plate thickness, smallest moment of inertia (which considers cross-sectional geometry),
and plate length are the primary variables for comparing stress between the various plates.

RESULTS AND DOCUMENTATION


All the verifications described above results in PASS (for specific Medical Electrical Equipment
requirements) or in acceptable levels of sterility/biocompatibility.

Test summary and all test activities performed are detailed in Section IV of DMF A.4.1.

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10. SUMMARY AND ANALYSIS OF CLINICAL DATA (STAGE 3)

Summary of clinical data

Data retrieved concerned safety and performance of the Oscar device, or of an equivalent device,
for both the applications of bone cement removal (references 1-13), and of bone cutting
(references 14-33).

Data were mostly derived from clinical studies (1-4, 8-33); however, as justified in Annex A,
2 cadaver studies were also included for safety considerations (6,7), as studies on heat transfer are
considered highly relevant being Oscar a piezo-electric, ultrasonic device involving transfer of heat
to the human body. Such studies can in fact only be performed on cadaver specimens for ethical
reasons, as patients would be exposed to unacceptable risks.
A report from the National Institute for Health and Care Excellence (NICE) was also
included in this evaluation as it provides specialist commentator observations on studies that
specifically assessed the performance and safety of the Oscar device (1-3). As it emerges from this
report and from Orthofix considerations, data only on the Oscar device (references 1-5) are
limited.
Thus, to assess data of sufficient quality and quantity, the literature evaluation included
studies on equivalent devices (references 6-33) that were used in orthopaedic applications
(references 1-13) as well in the fields of neurosurgery (14-21), Foot&Hand surgery (22),
craniofacial surgery (23,24), ENT surgery (25-33).
As also stated in Annex A, when osteotomies are performed in these fields (i.e. neuro-,
Foot&Hand, craniofacial, and ENT surgery), they involve operating in anatomic areas that are
intrinsically more at risk than those involved in orthopedics, as nerve structures are closer. If
devices equivalent to Oscar, having also an intended use for osteotomy in these additional fields,
were to be found safe and effective for these applications, safety and effectiveness of the Oscar
device for bone cutting in orthopedic surgeries would be proved all the more.

There is heterogeneity in the quality and type of study design of the clinical studies
included in this evaluation. The literature assessed comprised 5 case reports (1,3,9,22,31), 2 case
series (3,30), 11 retrospective studies (2,4,8,11,12,14,15,17,19-21), and 11 prospective studies
(10,18,23-29,32,33). One study (13) included clinical data collected both retrospectively and
prospectively.
Statistical analyses were conducted only in studies that included a relatively large number
of patients (2,11,14,19,25-29); in all studies probability values at less than 0.05 were regarded as
significant. Depending on the outcomes assessed, statistical analyses were undertaken, as

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appropriate, using the Wilcoxon signed rank test (2,11), Kaplan-Meier survival analysis (11), t-test
for continuous normal data (14,25-29), and the chi-square test or Fisher exact test for categorical
data (14, 19).

Overall, clinical studies assessed included a total of 2319 patients; of those, 1001 were
treated with either the Oscar device or with and equivalent device. The clinical studies included
both pediatric and adult patients, with extremes between 4 and 87 years, and both female and
male patients.

Even if prospective studies including a large cohort of patients treated with the Oscar
device are missing, overall data were of sufficient quality and quantity for allowing meaningful
assessment of the devices’ performance and safety.

Concerning the performance of the Oscar device or of equivalent devices, the papers
analyzed - when considered in the whole - outline a scenario that confirms that the device is safe
and performing for its intended use(s). Considering data retrieved in the whole, it can be stated
that no peculiar hazards emerge connected with the use of the device, with the main
complications being those already described in the clinical background in paragraph 4. The main
risk associated with the use of the device is thermal damage; this risk can be minimized by
adequate irrigation and surgical knowledge. These aspects are adequately addressed in the IFU of
the Oscar device.
In general, data retrieved show that the benefit deriving from the use of the piezoelectric
devices strongly outweighs the risks that they may carry.
A detailed analysis of the safety of the device under examination is provided in the next sections.

The table below summarizes the types of study included in this evaluation; for each study,
the number and characteristics of patients treated, and the post-operative follow-up period are
reported.
The articles full-texts are available in Annex B.

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Reference Medical Indication N. patients treated N. patients in Target population Design of the Follow-up
device with the device the study study

(1) Smith and Oscar Removal of a massive intrapelvic 1 1 83-year old woman. Case report N/A
Eyres, 1999 cement mass
(2) Fletcher et Oscar Cement removal in revision total hip 13 cases 16 (17 cases) 3 men, 13 women. Age: 62 to 87 years. Retrospective N/A
al., 2000 arthroplasties (Wagner prosthesis) case series
(3) Golberg et Oscar Cement removal from the humerus 1 1 Woman, 69-year-old. Note that the study also Case report 9 months
al., 2005 during revision arthoplasty included 6 human cadaveric specimens.
(4) Peach et Oscar Total elbow arthroplasty (TEA) 10 33 (34 cases) 23 women, 10 men. Mean age was 65 years Retrospective 52 months
al., 2013 revision (49 to 89). study (24 to
139).

(5) NICE, Oscar See references 1-3 See references 1-3 See See references 1-3. See See
2014 references 1-3 references 1-3 references
1-3
(6) Brooks et Biomet Ultra- Bone cement removal and bone Cadaver study on a See column N/A Cadaver study N/A
al., 1995 drive cutting certain number of on the left.
15 cm lengths of
human cadaver
femora.
(7) Brooks et Biomet Ultra- Bone cement removal. Cadaver study on See column N/A Cadaver study N/A
al., 1993 drive six 10 cm-long on the left.
sections of human
cadaver femora.
(8) Klapper et Biomet Ultra- Bone cement removal in revision hip 20 20 16 women and 4 men with hip prosthesis. Retrospective N/A
al., 1992 drive arthroplasty study
(9) de Steiger Biomet Ultra- Cement removal in hip arthroplasty 1 1 One male patient with hip prosthesis requiring Case report 2 months
et al., 1996 drive revision revision. Age:33.
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Reference Medical Indication N. patients treated N. patients in Target population Design of the Follow-up
device with the device the study study

(10) Haddad Biomet Ultra- Cement removal in revision hip 50 50 The patients were 27 women and 23 men with Prospective 5.8 years
et al., 2000 drive arthroplasty for infection a mean age of 60 years (24 to 81). study (2-8.7)
(11) Sneftrup Biomet Ultra- Bone cement removal in elbow 5 23 15 women and 8 men, with a median age of 62 Retrospective 55
et al., 2006 drive arthroplasty revision years (42 to 80) at the time of revision. study months
(15-97)
(12) Van Biomet Ultra- Cement removal during revision 23 23 Average age at revision was 69 years range, Retrospective 40.9
Thiel et al., drive shoulder arthroplasty. 52-81 years. study months
2011 (24-98)
(13) van Biomet Ultra- Cement removal in revision hip 136 136 63 female and 73 male, 64.4 ± 10.8 years. Retrospective 8.3 years
Diemen, 2013 drive arthroplasty +Prospective (2-15
data years)
assessment
(14) Bydon et Misonix Bone cutting in patients requiring 88 337 Of the 337 patients, 187 were male, and the Retrospective N/A
al., 2013 Ultrasonic posterior decompression of the mean age was 60.4 ± 16.2 years. In the study
BoneScalpel cervical or thoracic spine BoneScalpel treatment group, 49 patients
(55.7%) were male.
(15) Hu et al., Misonix Bone cutting in spine surgery 128 128 73 female, 55 male. The mean age of the Retrospective N/A
2013 Ultrasonic patients was 58 years (range 12–85 years). study
BoneScalpel
(16) Nickele Misonix Osteotomy for laminoplasty for either 5 5 N/A Case series N/A
et al., 2013 Ultrasonic tumor resection or DREZ lesion.
BoneScalpel
(17) Parker et Misonix Osteoplastic laminoplasty in the 40 40 29 adult and 11 pediatric patients. Sex: 20 male Retrospective Mean, 193
al., 2013 Ultrasonic resection of intradural spinal and 20 female. Mean age, 38.0 years; range, study days;
BoneScalpel pathology 4.0-79.7 years. median,
142 days.
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Reference Medical Indication N. patients treated N. patients in Target population Design of the Follow-up
device with the device the study study

(18) Al- Misonix Bone cutting in spinal surgey 62 937 Of the 62 patients treated with Bone scalpel: Prospective N/A
Mahfoudh et Ultrasonic 22 cases of primary lumbar laminectomy; 8 of study
al., 2014 BoneScalpel primary lumbar foraminotomies; 9 of revision
lumbar laminectomy; 4 cases of revision
lumbar foraminotomy/discectomy; 5 cases of
Facetectomies in association with
Transforaminal Lumbar Interbody Fusions
(TLIF); 7 cases of laminoplasty; 2 cases of
cervical corpectomy; 1 trench thoracic
vertebrectomy for excision of a calcified
thoracic disc; 2 cases of laminectomy for
access to intradural tumours (1 thoracic and 1
cervical); 2 cases of posterior cervical
foraminotomy.
(19) Bydon et Misonix Spinal Decompression in 10 30 Paediatric patients. In the BoneScalpel group, Retrospective 20.70±6.8
al., 2014 Ultrasonic Achondroplastic Patients mean age was 14.10±5.63 years. comparative 5 months
BoneScalpel study
(20) Misonix Ultrasonic total uncinectomy for 38 38 Mean age was 65 years (range, 43-80 years). Retrospective 28± 7
Pakzaban, Ultrasonic anterior decompression of cervical There were 17 men and 21 women. study weeks
2010 BoneScalpel nerve roots (14-37)
(21) Al- Misonix Management of Giant Calcified 29 29 Patients had herniated thoracic disk with pain Retrospective 19.8
Mahfoudh et Ultrasonic Thoracic Disks and paresthesia, weakness, thoracic back pain. study months
al., 2016 BoneScalpel 18 patients with giant calcified thoracic disks. (7months
Sex: 13 female, 16 male. The median age at to 2 years)
diagnosis was 51.2 years (range 37 to 70).
(22) Hoigne Mectron Correctional osteotomy of the 5th 1 1 23 years old, male. Case report 1 year
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Reference Medical Indication N. patients treated N. patients in Target population Design of the Follow-up
device with the device the study study

et al., 2006 Piezosurgery metacarpal bone.


(23) Kramer, Mectron Craniofacial surgery for frontoorbital 15 15 Mean age 11.3 years (6 – 34 years). 9 male, 6 Prospective 12 months
2006 Piezosurgery advancement female patients. study
(24) Gleizal et Mectron Craniofacial surgery 30 60 Median age was 6.2 months for patientstreated Non- N/A
al., 2007 Piezosurgery with the piezoelectric device and 6.4 months for randomized,
the mechanical group (with extremes between prospective
5 and 7 months for each group). clinical trial
(25) Salami et Mectron Otologic surgery 133 133 50 patients affected by otosclerosis, 50 cases Prospective 6 months
al., 2009 Piezosurgery of chronic otitis media, 20 cases of study
posttraumatic facial nerve palsy, 10 cases of
type A glomus tympanicum tumor and 3 cases
with a B-cell non-Hodgkin lymphoma. Age and
sex unknown
(26) Salami et Mectron Removal of symptomatic ear osteoma 10 10 Mean age 43.4, range 21-58 years. 7 males, 3 Prospective 6 months
al., 2010 Piezosurgery females. study
(27) Salami et Mectron Revision mastoidectomy with or 30 30 Age between 36 and 72 years (mean 58.2 Prospective 12 months
al., 2010 Piezosurgery without cholesteatoma. years). There were 18 females and 13 males. study
(28) Salami et Mectron Intact canal wall mastoidectomy 30 60 16 males and 14 females (mean age 44.1 Non- 12 months
al., 2010 Piezosurgery years) were treated with the piezoelectric randomized
device. prospective
study
(29) Crippa et Mectron Intact canal wall mastoidectomy 70 140 Age Range: 18-70. Mean Age 45.4 ± 2.6 for Non- 10 days
al., 2011 Piezosurgery the group treated with piezoelectric device. randomized
prospective
study
(30) Mectron Internal auditory canal drilling in 8 8 Mean age: 59.1 years (31-77 years). Patients Retrospective 3 months
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Reference Medical Indication N. patients treated N. patients in Target population Design of the Follow-up
device with the device the study study

Grauvogel et Piezosurgery acoustic neuroma surgery had acoustic neuroma. case series
al., 2011
(31) Heredero Mectron Spheno-orbital meningioma resection 1 1 52-years old woman. Case report 12 months
Jung et al., Piezosurgery
2011
(32) Mancini Mectron Endoscopic sinus surgery. 4 4 2 male and 2 female patients; mean age was Prospective 9 months
et al., 2012 Piezosurgery 55 years (48-63 years). case series

(33) Mectron Removal of retrovertebral body 9 9 5 female and 4 male; mean age in the patient Prospective Mean: 10
Grauvogel et Piezosurgery osteophytes in anterior cervical group was 58 years. case series months
al., 2014 discectomy

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Below, we provide a summary of the clinical data extracted from articles derived from the
literature search and from the analysis of the NICE report on Oscar 3.

About Orthofix Oscar 3


1 Smith, PN; Eyres, KS. Safe removal of massive intrapelvic cement using ultrasonic
instruments. J Arthroplasty. 1999;14(2):235-8.
The paper describes the case of single patient, female, 83-year old, who had had total hip
arthroplasty 12 years before. Because of malposition of the prosthesis resulting in limb
shortening, and penetration of the bone cement through the acetabolum during the primary
THA, she underwent a second surgery three months later. The patient complained, already
post-operatively, about pain in the buttock and thigh. In the following 2 years her pain
increased to the point she was no more able to perform routine housework and presented
seeking for relief.
As radiographic analysis showed a big cement mass protruding into the pelvis, together with
acetabular cup migration, lucency at the cement-bone interface, subsidence of the femoral
component and significant endosteal bone lysis, a treatment plan was designed calling for a
revision surgery.
The presence of a large cement mass protruding into the pelvis, close to major structures,
potentially called for achieving a second retroperitoneal access to mobilize these structures
away. Given the patient’s old age, to spare her such an invasive approach, the authors opted
to attempt removing the cement mass through the primary hip wound, avoiding use of force
or sharp instrument and resorting to ultrasonic bone cement removal using Oscar.
During surgery, the more peripheral cement was removed using conventional instruments
but the remaining part was sectioned using Oscar, and specifically the back-scraping tool.
This allowed to avoid any force directed inward to the pelvis. Cement sections were then
removed without undue traction being needed. Revision surgery then followed according to
standard operating technique.
As a result of the whole surgery the patient healed uneventfully.

Positive clinical results/positive outcomes


- the reconstruction was uncomplicated and the patient healed uneventfully
- a second surgical access was made unnecessary thanks to the use of the Oscar device
- bone cement removal was performed without the need of applying undue forces, i.e.
atraumatically
- because of the small probe size, access to cement was simple even in small spaces

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Complications/negative outcomes
- none
Other comments:
- no follow up is provided
2 Fletcher, M; Jennings, GJ; Warren, PJ. Ultrasonically driven instruments in the transfemoral
approach--an aid to preservation of bone stock and reduction of implant length. Arch Orthop
Trauma Surg. 2000;120(10):559-61.
The study aims to investigate the benefits, if any, in using ultrasonic bone cement removal
systems, and specifically the Orthosonics Oscar device, to treat cases of extensive
endosteolysis and peri-prosthetic fractures through the implantation of the Wagner SL stem
by a transfemoral approach. The transfemoral approach calls for exposing the full length of
the prosthesis and its cement mantle, permitting their rapid removal. Yet, this leads to
possible waste of good bone stock. Using Oscar, the authors modified this technique
stopping the osteotomy to the distal limit of the osteolysis, instead of prolonging it to the
limit of the prosthetic bed (i.e. the distal cement mantle). Similarly, for periprosthetic
fractures, the osteotomy was limited to the proximal fragment. Cement removal followed
using the Oscar device. Data concerning 16 patients (suffering from proximal endosteolysis
(10), Periprosthetic fracture type II (3); non-union of type III peri-prosthetic fractures (1),
femoral component stem failure (2)) were collected retrospectively and pre-operative
radiographs reviewed according to a “what if” approach, i.e. assessing what the length of the
osteotomy would have been if a conventional approach had been followed. This length was
compared to the actual one that had actually been performed following the modified
approach. The same approach was followed to measure the length of the hypothetic
prostheses placed under the conventional approach and those actually placed. Oscar was
actually used in 13 out of 17 cases (one patient was bilateral). Revisions were completed
successfully.

Positive clinical results/positive outcomes


- in all cases where Oscar was used, a significantly shorter osteotomy (mean difference
= 7 cm, range 2-13) could be performed.
- in all cases where Oscar was used, there was no need to extend the initial osteotomy
as the use of Oscar permitted easy removal of the distal cement.
- in 60% of cases where Oscar was used, a significantly shorter prosthesis could be
placed
- time needed to remove bone cement did not exceed 15 minutes; in several cases
cement removal was accomplished in less than five minutes

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Complications/negative outcomes
- no cortical breach or femoral shaft perforation could be observed, thanks also to the
alarm alerting the surgeon when the tip comes in contact with cortical bone.
Other comments:
no follow up is provided
3 Goldberg, SH; Cohen, MS; Young, M; Bradnock, B. Thermal tissue damage caused by
ultrasonic cement removal from the humerus. J Bone Joint Surg Am. 2005;87(3):583-91.
This paper describes a) a case of a patient suffering from complications consequent to an
elbow prosthesis revision where Oscar was used and b) the following investigation on
cadaver specimens to understand if complications could be attributed to overheating caused
by Oscar itself and what is the effect of irrigation on tissue heating while using Oscar.
A woman, 69-year old suffered from a fracture-dislocation of the right elbow and was
initially managed with open reduction, radial head replacement, and application of a hinged
external fixator. Because of persistent pain and limited range of motion, she underwent a
semi-constrained total elbow arthroplasty with cement approximately one year after the
injury. postoperative course was complicated by an early infection. Two years after the total
elbow arthroplasty, because of persistent drainage and progressive osteolysis, the patient
underwent implant and cement removal from both the humeral and ulnar canals. Cement
removal was performed using Oscar; during ulnar cement removal, the lateral cortex was
perforated. The patient developed postoperatively a complete proximal radial nerve palsy.
Two weeks after surgery, the patient presented with a spiral fracture of the humerus. This
fracture was presumed to be pathologic because of the lack of antecedent injury or trauma.
Further treatment using a plate followed. During fracture reduction and plate positioning,
widespread muscle necrosis was observed. Intraoperative biopsy specimens were obtained
from the humerus, the triceps, and the superficial portion of the radial nerve. Pathologic
sections revealed complete necrosis of muscle, cortical bone, and nerve tissue.
Approximately seven months postoperatively, she underwent a staged total elbow re-
implantation with use of femoral strut allografts and a semi-constrained prosthesis. No
follow-up data are available.
To investigate the reasons of complications observed, a study was performed on six human
cadaveric specimens: after placing temperature probes within the humeral cortex, the
triceps muscle, into the radial nerve, cement was inserted into the humeral medullary canal
and a humeral prosthesis inserted. After the cement became firm, it was removed using the
Oscar device to remove cement, recording temperature without irrigation and under
irrigation. During cement removal with use of rapid and constant ultrasonic application, the
temperatures were markedly elevated in all tissues. Use of the recommended cement-
removal technique, including chilled irrigation with use of a bulb syringe between each
ultrasound pass, limited the heat generation and transmission in all tissues tested.

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Positive clinical results/positive outcomes
- none
Complications/negative outcomes
- When Oscar was used a cortical ulnar fracture occurred
- It is highly probable, considered the findings on cadaver specimens, that Oscar caused
overheating that, in turn, caused muscle, bone and nerve necrosis, provoking both the
palsy and indirectly the humerus fracture.
Other comments:
- findings on cadaver specimens highlight the importance of
a) proper irrigation
b) proper removal technique
to avoid overheating.
4 Peach, CA; Nicoletti, S; Lawrence, TM; Stanley, D. Two-stage revision for the treatment of the
infected total elbow arthroplasty. Bone Joint J. 2013;95-B(12):1681-6.
This work describes the results of a retrospective assessment of data concerning 33 patients
who underwent 34 total elbow arthroplasty (TEA) and were subjected to elbow arthroplasty
revision because of infection. Only patients with a follow-up period ≥ 2 years were included
in the assessment. To eradicate the infection, a first stage was always required and was
sufficient in 85% of the cases. The other 15% required between 2 and 4 first stage before
second stage could be performed. Eight TEAs did not go second stage surgery. 26 had
second-stage surgery with the insertion of a further TEA. In both groups, some patients
experienced post-operative or late complications as listed in the following section.
Concerning second-stage TEAs, functional outcome at the final follow-up was: nine excellent
(35%), five good (19%), ten fair (38%) and two poor (8%) using the Mayo elbow performance
score (MEPS). In about ten patients (see e-mail from Dr. Peach) the Oscar device was used
to remove bone cement during first-stage revisions. In none of these cases complications
were observed.
Positive clinical results/positive outcomes
- the ten patients having their bone cement removed using Oscar experienced no
complications (implicitly, Oscar was safe and effective in removing bone cement)
Complications/negative outcomes
- complications observed were as follows:
- a) in patients undergoing two-stage revisions
3 (8.8%) had a recurrent infection

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1 (2.9%) had triceps weakness at a long term (24 months post-op)
1 (2.9%) had a peri-prosthetic ulnar fracture at 24 months post-op
- b) in patients non undergoing a second stage procedure:
1 (2.9%) had a recurrent infection
- no patients suffered from neurological complications
Other comments:
no follow up is provided
5 NICE - The National Institute for Health and Care Excellence. The OSCAR 3 ultrasonic
arthroplasty revision instrument for removing bone cement during prosthetic joint revision.
Published: 19 November 2014
The NICE reports summarize the studies of Fletcher et al, 2000; Smith et al, 1999 and
Goldberg et al., 2005. These three publications are among those retrieved by the literature
search done and included in the present evaluation. Their assessment by the NICE and the
assessment provided in the present report are consistent (see references X in this same table
and NICE comments at page 2 and pages 10 to 15 of the NICE report).
Further, and with reference to the three studies mentioned above, the NICE report
underlines how the published evidence to support the clinical effectiveness of the OSCAR
cement removal system is lacking in both quantity and quality (page 16). This supports the
Orthofix choice of extending the literature search to equivalent devices too.
The NICE report on OSCAR 3 provides interesting specialist commentator comments at page
9, that may be briefly summarized as follows:
a) One specialist commentator advised that the main role of the OSCAR is to remove
the cement mantle from the intramedullary canal of the femur during total hip
replacement revision, and the femur or tibia during total knee replacement revision.
This can prevent the need for osteotomy, protect the bone by avoiding perforation
or fracture and speed up the procedure.
b) Another specialist commentator advised that the OSCAR is most useful during hip
revision for the removal of well-fixed distal femoral cement and cement plugs distal
to the prosthesis. The use of the OSCAR system reduces both the risk of femoral
perforation and the need for femoral osteotomy compared with the use of
mechanical instruments alone. It also allows for use of shorter femoral prostheses,
thus preserving distal femoral bone.
c) A third specialist commentator uses OSCAR in combination with cement chisels, drills
and powered burrs. OSCAR applications include removing cement from the bones of
patients with osteoporosis, where the risk of perforating the femoral cortex is great,
and in femora with a thin layer of cement and a sloping edge that will not engage a
chisel. Its use reduces the incidence of extended trochanteric osteotomy. A lack of
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controlled trials of OSCAR in the evidence base may be explained by ethical concerns
over conducting an osteotomy in a control patient when the use of OSCAR would
make it unnecessary. In addition, patient outcomes with OSCAR can be very operator
dependent, requiring skill and practice to be used effectively.

About Biomet Ultradrive


6 Brooks, AT; Nelson, CL; Hofmann, OE. Minimal femoral cortical thickness necessary to
prevent perforation by ultrasonic tools in joint revision surgery. J Arthroplasty.
1995;10(3):359-62.
This paper describes a cadaver study on a number of 15 cm-long sections of human cadaver
femora. The purpose of the study was to measure the load bone undergoes when a) bone
cement was removed or b) bone cutting was performed at the endosteal surface using the
Biomet Ultra-Drive 3 device. To do that, in two specimens a cement mantle using PMMA
cement was constructed in the intramedullary canal. The remaining specimens were also
prepared for cementing; however, cement was not inserted. The cortical thickness of these
specimens was measured with a caliper. Specimens were mounted on a mechanical force
measuring system and bone cement removal/bone cutting was performed using the Biomet
Ultra-Drive 3 device. In samples with cement, application of the device caused no cortical
perforations or fractures. In samples without cement, when the cortex measured 3 mm
thick, perforation did not occur. When the cortex measured 2 mm, perforation was possible
but required loads three to six times greater than those normally used to remove cement.
The risk of perforation was greatest when the cortex was 1 mm or thinner, although it was
necessary to apply loads above those normally used to remove cement.
Positive clinical results/positive outcomes: N/A
Complications/negative outcomes: N/A
Other comments:
Results of this paper highlight that a residual risk of bone perforation exists only if cortical
bone is thin (about 1 mm). Yet, the loads to apply to observe fracture are greater than those
normally used to remove cement. Otherwise the risk of fracture is definitively reduced.
7 Brooks, AT; Nelson, CL; Stewart, CL; Skinner, RA; Siems, ML. Effect of an ultrasonic device on
temperatures generated in bone and on bone-cement structure. J Arthroplasty.
1993;8(4):413-8.
This paper describes a cadaver study on six 10 cm-long sections of human cadaver femora.
The purpose of the study was to measure the effect on temperature on bone and bone
cement structures when bone cement was removed using the Biomet Ultra-Drive 3 device.
To do that, a cement mantle was constructed in the intramedullary canal. A temperature
probe was then inserted into predrilled holes and temperatures generated by the ultrasonic
device were recorded under a variety of conditions. In addition, a cement cylinder was
microscopically evaluated after an ultrasonic tool had been inserted. Temperatures
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generated by the ultrasonic tool were no higher than temperatures of 140°C generated by
high-speed drills. Furthermore, temperatures at the bone-cement interface never exceeded
60°C when saline irrigation was used in conjunction with the ultrasonic tools, and were
below 40°C 1 minute after deactivation of the device. Microscopic examination showed that
ultrasound produced local changes in the structure of bone-cement converting it from a
microscopically spherical interlocked material to one that appears homogeneous and
granular.

Positive clinical results/positive outcomes: N/A


Complications/negative outcomes: N/A
Other comments:
Results of this paper highlight that a residual risk of overheating exists yet it can be
effectively minimized by irrigating the bone cement removal site properly.
8 Klapper, RC; Caillouette, JT; Callaghan, JJ; Hozack, WJ. Ultrasonic technology in revision joint
arthroplasty. Clin Orthop Relat Res. 1992;(285):147-54.
This paper describes both results on animals and on patients. Only results on patients will be
summarized here. 20 patients, 16 women and 4 men, needed revision hip arthroplasty. All
patients were treated with Ultrasonic Tool System (Ultra Drive Device). 19 femoral
components were revised. During surgery, the Ultra Drive device was used inserting different
tips on the handpiece: osteotome, shallow curve gouge, deep curve gouge, disc drill, plug
puller, acetabular gouge and flexible osteotome. For each revision 4 stages were performed:
1) Component removal; 2) Proximal cement removal; 3) Removal of cement from the shaft;
4) Distal cement plug removal. The 20 patients were treated successfully. In the femoral
revisions done with ultrasonic tools, there were no cortical perforations nor were cortical
windows created for component or cement removal. The distal plug removal was facile
whether the plug was short, long, well-fixed or loose. The bone proximal stock was easily
preserved. Flexible ultrasonic osteotomes showed to be optimum tools for disrupting the
prosthesis-cement bond in case of precoated or porous coated removal component.
Positive clinical results/positive outcomes
- The device facilitated bone cement removal
- Surgical outcome was successful

Complications/negative outcomes
- none

Other comments:
- this paper highlights the versatility of the Ultra-Drive device achieved thanks to the
wide range of tips available

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- auditory feedback was a useful help for surgeons
9 de Steiger, RN; Pandey, R; McLardy-Smith, P. Ultrasonically driven tools. J Arthroplasty.
1996;11(1):120-1.
The paper describes a case of a patient affected with Perthes’ disease, who had undergone a
cemented left Charnley hip arthroplasty and required revision after 13 years due to
loosening. No infection was present. The patient underwent revision through a routine
Hardinge approach. A one stage revision procedure to a cement-less hip was carried on. The
acetabular and the femoral components were removed and the Ultra-Drive Device was used
for cement removal. The acetabular component was removed with ease. On the contrary,
the femoral one was removed with some difficulties along with cement down to the distal
plug. This difficulty was caused by the surgeon, because the plug remover was not securely
connected to the long stem rod and became detached. A significant perforation was made to
remove both cement and the plug remover, then the femur was reconstructed over a long-
stem cementless femoral component and secured with cerclage wires. Autologous bone
graft was used. After surgery, the patient was mobilized non-weight bearing in a cast brace
for 1 month. Two months after the patient was comfortably partially weight bearing and the
osteotomy site was uniting well. The result, in conclusion, was positive.

Positive clinical results/positive outcomes:


- the Ultra-drive device was effective in removing bone cement
Complications/negative outcomes:
- the case highlights how proper connection of the tools to be attached to the ultrasonic
handpiece is mandatory to avoid intra-operative complications like the one described.
Other comments:
- None
10 Haddad, FS; Muirhead-Allwood, SK; Manktelow, AR; Bacarese-Hamilton, I. Two-stage
uncemented revision hip arthroplasty for infection. J Bone Joint Surg Br. 2000;82(5):689-94.
In this prospective study the successful treatment of 50 consecutive patients with infected
total hip arthroplasties, according to a standard protocol was described. All patients had
cemented arthroplasties with sepsis and had at least one of the following: an organism
cultured before open operation, systemic symptoms with a painful hip, a sinus
communicating with the prosthesis, or purulent fluid at exploration. The treatment is briefly
described as follows:

1) The first stage of the surgery consisted of excision of sinuses and removal of
foreign and potentially infected material: cement, plugs and any potentially infected
soft tissue. Both femoral and acetabular implant sites were reamed thoroughly and
washed.
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Ultradrive was used at this first stage, guided by intraoperative fluoroscopy, in
order to remove the cement.
Samples were taken for culture before cement removal. Antibiotics were placed in
femoral shaft and the acetabulum (in the last case, an antibiotic-loaded cement was
placed). In the end of the first stage, the wounds were closed over suction drains.
Radiographs were taken in the interval time between stages 1) and 2).

2) At the second stage of the clinical procedure, an uncemented arthroplasty was


introduced. Bone allograft was used in 18 patients. The interval between the stage 1)
and 2) was usually three weeks, but this was extended in some cases (e.g.
wound slow to heal). Antibiotics were given for three months.

Positive clinical results/positive outcomes

The use of Ultradrive at the first stage of the procedure in order to remove the cement was
successful.

Complications/negative outcomes
At a mean follow-up of 5.8 years a satisfactory clinical and radiological outcome was
obtained in all except two patients. The rate of reinfection was 8% (4 patients). Two of these
patients have had another, successful, two-stage revision. Prolonged immobilisation may
well have contributed to the early postoperative complications. These included cardiac
failure (2 cases), pulmonary embolism (1 cases), haematemesis (2 cases), infection of the
urinary tract (9 cases), palsy of the common peroneal nerve (1 case) which recovered, and
four dislocations managed by closed manipulation.

Other comments:
No complication was device-related.
11 Sneftrup, SB; Jensen, SL; Johannsen, HV; Søjbjerg, JO. Revision of failed total elbow
arthroplasty with use of a linked implant. J Bone Joint Surg Br. 2006;88(1):78-83.
The study describes the results of a retrospective study involving 23 patients who had been
subjected to total elbow arthroplasty and needed arthroplasty revision. The indication for
the primary elbow replacement was rheumatoid arthritis (16 patients), a fracture of the
distal humerus (4), post-traumatic osteoarthritis (3), and primary osteoarthritis (1). The
main indication for revision was aseptic Loosening (15 elbows). Other reasons included
periprosthetic fractures (6 elbows and 5 patients), instability (1) and deep infection (2). The
mean interval between the primary arthroplasty and the revision was 75 months (1 to 241).
During surgery both components of the arthroplasty were replaced with a linked Conrad-
Morrey implant. Bone cement was removed using the Biomet Ultra-drive device in 5 cases.
The five-year survival of the prosthesis was 83.1% (95%). confidence interval (CI) 61.1 to
93.3). The survival rate of the procedure described in this study resulted acceptable. On the
basis of the Mayo Elbow Performance Score the subjective, objective and functional

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characteristics were quantified and evaluated both before the primary operation and after
the revision at the latest clinical evaluation. The results were defined as: excellent (90 to 100
points), good (75 to 89), fair (60 to 74) or poor (fewer than 60). The median pre-operative
total score was 35 points compared to 85 points at follow-up. A significant improvement was
seen in all subcategories of the performance score (e.g. pain score), except for range of
motion, for which only the “flexion” subcategory had improved.
Positive clinical results/positive outcomes
- Revision with a linked prosthesis is a viable option in failed total elbow arthroplasty and
provided a satisfactory functional result.
- The device was important for preparing safely and effectively the sites and thus for
guaranteeing the success of the second surgery stage.
Complications/negative outcomes
- four prostheses in four patients were removed within 18 months from revision for a)
loosening of the ulnar component (two re-revisions for the same reason); b) deep
infection (first re-revision) and loosening of the ulnar component (second re-revision);
c) deep infection (two re-revisions); d) loosening of the ulnar component (re-revision
later followed by excision arthroplasty).
- Thirteen of the 24 elbows (54.2%) had a total of 16 complications, necessitating eight
re-operations in four elbows. There was one intra-operative complication, a humeral
fracture that occurred in a patient with severe rheumatoid arthritis. The fracture was
stabilised with cerclage wiring. Ulnar paraesthesia was described in the first few days in
five patients who had had no nerve symptoms prior to the revision. It had resolved in
all but two patients at the time of follow-up, and motor deficiency was not observed.
Radial nerve neuropathy was present in three patients, one sensory (case 23) and two
with combined sensory and motor deficiencies (cases 9 and 13). No nerve damage was
noted during the revision procedure except in case 9, where narrowing of the nerve
was noted in relation to the humeral fracture. One patient (case 17) demonstrated
triceps insufficiency one year after operation, which was characterised by inability to
extend the elbow against gravity. The Ultra-Drive device was not used in Cases 23, 9,
13 and 17
- one patient (whose bone cement had been removed using the Ultra-drive device)
complained of a painful elbow with limited rotational movement at the most recent
follow-up. This complication seems not related to the ultrasonic device (as the onset is
late).
Other comments:
- none
12 Van Thiel, GS; Halloran, JP; Twigg, S; Romeo, AA; Nicholson, GP. The vertical humeral
osteotomy for stem removal in revision shoulder arthroplasty: results and technique. J

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Shoulder Elbow Surg. 2011;20(8):1248-54.
This investigation was a retrospective study on patients subjected to a revision shoulder
arthroplasty and that had novel VHO (vertical humeral osteotomy) performed for humeral
stem removal. The study aimed to assess if VHO allows avoiding perioperative or
postoperative fractures. 27 patients were identified (average age at revision was 69 years
range, 52-81 years) and 23 were available at the final follow-up (40.9 months (range, 24-98
months). The etiology for the original arthroplasty was fracture (10 patients), cuff tear
arthropathy (7), osteoarthritis in (6). The subsequent revision arthroplasties included
hemiarthroplasty to reverse (14), hemiarthroplasty to total shoulder arthroplasty (6), total
shoulder arthroplasty to reverse (1), and hemiarthroplasty to hemiarthroplasty (2). There
were 14 cemented stems and 9 uncemented humeral stems. There were 7 cases of
infection, thus requiring cement total removal in the revision procedures. All patients -with
both cement or uncemented humeral stems- underwent a new vertical humeral osteotomy
(VHO) for stem extraction, in order to reduce the risk of multiple potential complications of
revision shoulder arthroplasty. After the implant was removed, if there was not an
infectious process, a new implant could be cemented into the old cement mantle without
removal of the remaining cement mantle. On the contrary, in the 7 cases of infection, all
foreign material was removed, including the entire cement mantle and the distal plug, using
the Biomet Ultra-Drive device, without extending the osteotomy through. Finally, the stem
component was inserted. Radiograph were taken for fractures or component loosening. All
revision stems were successfully cemented. There were no intraoperative diaphyseal or
metaphyseal fractures. Follow-up radiographs revealed no implant-cement lucencies or
loosening at an average of 41 months and no extruded cement was seen in the diaphyseal
region. No periprosthetic fractures have occurred. Clinical scores were obtained at final
follow-up, including the American Shoulder and Elbow Surgeons score, Simple Shoulder
Test, and visual analog scale for pain. Shoulder function outcome scores were variable. At
an average follow-up of 41 months, average ASES score was 64.7 (contralateral ASES, 76.9),
average SST was 6.3, and the VAS pain average was 1.3. There were no instability events. All
patients stated they would undergo the procedure again and were pleased with the result.

Positive clinical results/positive outcomes


- Authors don’t report any issue/complications related to the use of the Ultra-Drive
device, implicitly implying it was effective for its intended use
- No periprosthetic fractures, either perioperative or postoperative occurred, confirming
the working hypothesis of the authors.
Complications/negative outcomes
- none
Other comments:
- none

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13 van Diemen, MP; Colen, S; Dalemans, AA; Stuyck, J; Mulier, M. Two-stage revision of an
infected total hip arthroplasty: a follow-up of 136 patients. Hip Int. 2013 ;23(5):445-50.
This study describes an analysis of clinical data that were collected both retrospectively and
prospectively (the authors defined the target population, identified subjects retrospectively
and assessed them prospectively using questionnaires measuring function scores). The
target population was that of patients subjected to a resection hip arthroplasty for the
treatment of a periprosthetic infection of a primary THA, followed by a revision arthroplasty
at a later stage. Patients were prospectively contacted by mail with a modified Harris Hip
Score questionnaire to complete and a Visual Analogue Scale for pain (VAS pain) to record
their current status. The main goals were to evaluate the degree of function after reinsertion
of a THA and to determine complication rates and infection control after performing two-
stage revision surgery for an infected THA. 136 patients were retrospectively identified
according to their medical records. During resection arthroplasty, all had bone cement
removed using the Biomet Ultra-Drive device. After collecting fluid and tissue samples for
microbiological analysis, prefabricated antibiotic-loaded cement spacers were positioned.
THA was reinserted only when the C-reactive protein level and the erythrocyte
sedimentation rate were back in the normal range, and no clinical signs of infections could
be observed, after stopping antibiotics for at least two weeks. In all revision arthroplasty, the
acetabular component was cementless, the femoral component was cementless in most
cases. At latest follow-up, the average modified Harris Hip Score was 63% and the average
Hip dysfunction and Osteoarthritis Outcome Score was 54%. The average VAS for pain was
26.8 points, and 40% of patients had no pain in the operated hip. The study does not
mention any complication related to the resection arthroplasty.

Positive clinical results/positive outcomes


- The authors findings are consistent with previously published literature data showing
that two-stage revision surgery has an acceptable outcome in this target population,
has a high rate of success for control of the infection and patients have good pain relief.
- The authors also confirm that complications are common in the long term and hip
function improvement is modest.
- concerning the Biomet Ultradrive device authors don’t provide any specific feedback.
This may implicitly imply that the device was effective for the intended use of removing
bone cement.
Complications/negative outcomes
- The authors don’t provide useful information concerning complications following
resection arthroplasty.
- Revision surgery was performed on average 4.7 ± 3.2 months after resection.
Complications following revision surgery were as follows: one patient suffered sciatic
nerve damage with a permanent drop foot (description of this complication is
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ambiguous, it is not clear when it was observed). Acetabular collapse occurred in one
patient during the revision procedure. Other complications consequent to revisions
were as follows: -Periprosthetic fractures, 12 (11 were femoral and 1 acetabular). -Leg
length discrepancy, 11 cases -Dislocation, 9 cases -Severe abductor muscle weakness, 4
cases -Massive hematoma, 2 cases -Bursitis trochanterica, 2 cases -Intraoperative
acetabular collapse, 1 case -Sciatic nerve damage, 1 case -Aseptic loosening, 1 -Non-
uniting femoral osteotomy, 1 case -Quadriceps shortening 1 case -Tibia fracture, 1
case. No relation can reasonably be established between these complications and the
use of the Biomet Ultra-drive device on the first surgery on the basis of data provided
by the authors.
Other comments:
- none

About Misonix Ultrasonic BoneScalpel


14 Bydon, M; Xu, R; Papademetriou, K; Sciubba, DM; Wolinsky, JP; Witham, TF; Gokaslan, ZL;
Jallo, G; Bydon, A. Safety of spinal decompression using an ultrasonic bone curette compared
with a high-speed drill: outcomes in 337 patients. J Neurosurg Spine. 2013;18(6):627-33.
This retrospective study describes the treatment of 337 consecutive patients who had
undergone posterior cervical and/or thoracic decompression with or without instrumented
fusion for extradural pathologies. Of 337 patients, 234 (69.4%) had degenerative disease, 37
(11.0%) had metastatic tumor, 23 (6.8%) had trauma, 20 (5.9%) extradural tumor, 11 (3.3%)
osteomyelitis, 3 (0.9%) epidural hematoma, 9 (2.7%) epidural abscess. 337 consecutive
patients underwent posterior cervical or thoracic decompression. 88 patients were treated
using an ultrasonic bone curette, 249 were treated using a traditional high-speed drill. The
BoneScalpel was used in 70 patients (79.5%) who underwent decompression at 1–3 vertebral
levels, in 18 patients (20.5%) who had 4–6 levels decompressed. In the high-speed drill
cohort, 206 patients (82.7%) had 1–3 vertebral levels decompressed, 41 (16.5%) had 4–6
spinal levels decompressed, and 2 (0.8%) required more than 6 levels of spinal
decompression. 5 (5.7%) of patients treated using an ultrasonic bone curette and 9 (3.6%) of
patients treated using traditional high-speed drill had an unintentional durotomy, a common
complication of spine surgery, though this finding was not statistically significant. The
treatment was successful for all patients

Positive clinical results/positive outcomes

Ultrasonic curette tears tended to be more linear in quality with respect to traditional high-
speed drill. The device showed to be at least as safe and efficacious as the conventional high-
speed drill.
Complications/negative outcomes

5.7% of patients treated using an ultrasonic bone curette and 3.6% of patients treated using
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traditional high-speed drill had an unintentional durotomy, a common complication of spine
surgery. Anyhow, no patients who experienced an incidental durotomy had new-onset or
permanent neurological deficits postoperatively. Although patients treated using an
ultrasonic bone curette tended to have a longer hospital length of stay, no patients in either
cohort experienced statistically higher rates of perioperative complications. This difference
may be attributed to the fact that this series contained a statistically higher number of
metastatic tumor.

Other comments:

Curette tears tended to be more linear in quality with respect to traditional high-speed drill
and to be lateral in location and craniocaudal in orientation too.

15 Hu, X; Ohnmeiss, DD; Lieberman, IH. Use of an ultrasonic osteotome device in spine surgery:
experience from the first 128 patients. Eur Spine J. 2013;22(12):2845-9.
This work describes the results of a retrospective assessment of data concerning 128
patients who underwent several types of osteotomy: facetectomy, laminotomy,
laminectomy, en bloc resection, Smith Petersen osteotomy, pedicle subtraction
Osteotomy. In all cases, the ultrasonic Misonix BoneScalpel was used to create the needed
osteotomies to facilitate the surgical procedure without any percussion on the spinal
column or injury to the underlying nerves. The ultrasonic scalpel was used at all levels of
the spine and the average levels operated on each patient were 5. 11 instances of dural
injuries (8.6 %) were experienced.

Positive clinical results/positive outcomes


The device facilitated straight line osteotomy procedures, carried on successfully on 128
patients. There was a noticeable absence of bleeding from the cut end of the bone
consistent with the ultrasonic application.

Complications/negative outcomes
A total of 11 dural injuries (8.6 %) occurred in this case series. Since majority of the patients
had previous spine surgery and/or spinal deformity, this dural injury rate is comparable with
previous reports. Of these 11 cases, only 2 cases of dural injuries directly associated with the
use of ultrasonic device. The first case was a 3 mm dural thermal injury which resulted from
the overheating of the local tissue by the scalpel blade sitting in one position. This was over
sewn with a watertight closure. The second dural injury occurred in a revision case where
the dura was adherent and partially ossified. As the osteotomy was created and the bone
peeled off, the dura was torn in the lateral recess of the epidural canal. This was repaired
primarily with a dural patch. However, the patient developed positional headaches, nausea
and vomiting postoperatively. A MRI scan at 1 month postoperative showed a large complex
fluid collection in the posterior paraspinal soft tissues. The patient underwent a revision
surgery to repair the pesudomeningocele and she recovered well from the revision surgery

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and reported significant improvement with pain and posture.

Other comments:
no follow up is provided
16 Nickele, C; Hanna, A; Baskaya, MK. Osteotomy for laminoplasty without soft tissue
penetration, performed using a harmonic bone scalpel: instrumentation and technique. J
Neurol Surg A Cent Eur Neurosurg. 2013;74(3):183-6.
The publication describes five cases in which the Misonix BoneScalpel was used to perform a
laminoplasty for various pathologies were: one cervical intramedullary tumor, one thoracic
intramedullary spinal mass, one lumbar extramedullary intradural tumor, and two cases of
multiple lower brachial plexus nerve root avulsions requiring dorsal root entry zone (DREZ)
lesion. All patients underwent similar surgery procedure. After proper preparation and
preliminary surgical steps, the Misonix BoneScalpel was used to perform a continuous cut
through the laminae of vertebra, on both sides. Motor evoked potentials (MEPs) and
somatosensory evoked potentials (SSEP) were used for the procedure, and there were no
changes in these monitoring modalities during laminotomy. Duraplasty was then performed
with a dural substitute, and bone was replaced in situ and secured with plates. SSEP and
MEP monitoring were not affected by the use of the bone scalpel during the laminoplasty.

Positive clinical results/positive outcomes


- minimal bone was lost during the laminotomy, allowing in situ laminoplasty
- the tip did not cut, penetrate, or otherwise mechanically damage the underlying soft
tissue
- using the device obviated the need to place any instrument under the intact lamina.
- there was no damage to the soft tissue underlying the lamina
- very little bleeding was observed from the bone edge
- in all cases there was no injury to the dura.

Complications/negative outcomes
- the aerosol generated by the device did not allow to properly visualize the dura

Other comments:
- additional irrigation was used to supplement the built-in one as authors were highly
concerned of overheating
17 Parker, SL; Kretzer, RM; Recinos, PF; Molina, CA; Wolinsky, JP; Jallo, GI; Recinos, VR.
Ultrasonic BoneScalpel for osteoplastic laminoplasty in the resection of intradural spinal
pathology: case series and technical note. Neurosurgery. 2013;73(1 Suppl Operative):ons61-
6.

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In the present retrospective study, a variety of pathologies were treated including 30
neoplastic, 6 congenital, 2 vascular, 1 inflammatory, and 1 neuropathic
pain. In the procedure, a longitudinal laminar cut at the spinolaminar junction was then
made bilaterally using the ultrasonic BoneScalpel. After scoring of the laminar incision, the
BoneScalpel was used to sequentially deepen the laminar cuts until the underlying interior
laminar cortex was penetrated, thereby exposing the ligamentum flavum. Successful
laminoplasty was carried out in all 40 cases and the device precisely cut bone while
preserving underlying soft tissues.

Positive clinical results/positive outcomes

In this study there was a 2.5% durotomy rate with the use of the ultrasonic osteotome in this
series. In comparison, our institution previously reported a durotomy rate of 4.3% with the
use of the high-speed drill, traditional technology, in a trial based on spinal fusion.
BoneScalpel showed to be a safe and technically feasible device for performing osteoplastic
laminoplasty.

Complications/negative outcomes
1 case of cerebrospinal fluid
leak, 1 case of seroma. The cerebrospinal fluid leak developed 2 weeks postoperatively and
was managed successfully by oversewing the wound in the outpatient setting. The epidural
seroma required operative evacuation, and the laminoplasty bone was removed because of
the possibility of infection at the time of surgery. 1 case (2.5%) of incidental durotomy after
osteoplastic laminotomy. It resulted in no neurological injury and was repaired primarily
without subsequent cerebrospinal fluid leakage. This occurred during the user’s first
experience with the device and was visualized as a linear heat-related defect likely caused
by excessive downward pressure after the inner laminar cortex had been cut.

Other comments:
Of the 40 cases, 11 were pediatric patients.
18 Al-Mahfoudh, R; Qattan, E; Ellenbogen, JR; Wilby, M; Barrett, C; Pigott, T. Applications of the
ultrasonic bone cutter in spinal surgery--our preliminary experience. Br J Neurosurg.
2014;28(1):56-60.
This study describes results of a prospective collection of data concerning 937 patients
undergoing spinal surgery. For 62 of them, surgery was performed with the aid of the
Misonix Bone Scalpel ultrasonic bone cutter; there were 22 cases of primary lumbar
laminectomy, 8 of primary lumbar foraminotomies, 9 of revision lumbar laminectomy, 4
cases of revision lumbar foraminotomy/discectomy, 5 cases of facetectomies in association
with Transforaminal Lumbar Interbody Fusions (TLIF), 7 cases of laminoplasty (4 cervical, 2
thoracic and 1 lumbar), 2 cases of cervical corpectomy, 1 trench thoracic vertebrectomy for
excision of a calcified thoracic disc, 2 cases of laminectomy for access to intradural tumours
(1 thoracic and 1 cervical) and 2 cases of posterior cervical foraminotomy. Complications
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were observed in 11 cases (17.7%) (see following paragraphs). Of these only one (1.6%, a
dural lesion), was caused by the Misonix Bone Scalpel, all other cases were regarded as
unrelated to the device. The complication rate observed (17.7%) is consistent with that
usually observed in spinal surgeries. The authors concluded that the bone scalpel is a useful
adjunct in spinal surgery and it appears to be associated with less blood loss.
Positive clinical results/positive outcomes
- on the base of their experience, the authors observed that the use of the Misonix Bone
Scalpel might be indicated for the following applications and have the following
advantages:

Revision Lumbar decompressions: could be performed as a revision microdiscectomy, the device


aiding in creating a bony window and find “virgin” dura avoiding
scar tissue. A similar principle is applied in revision
laminectomies.
Laminoplasty: the ultrasonic bone scalpel could minimize
neurovascular and soft tissue damage.
Cervical corpectomy. the authors found the Misonix Bone Scalpel helpful to
expedite this procedure and minimise blood loss.
Thoracic trench vertebrectomy: again may accelerate the osteotomy while preserving the
radicular vessels and minimising blood loss.
Lateral decompression of the lumbar canal: aids in removing bone up to the pedicle without the need of an
osteotome, for example exiting root decompression in
conjunction with posterolateral instrumented fusion.

Complications/negative outcomes
- complications (total rate being 17.7%) were as follows:
Related to the Misonix Bone Scalpel:
- one dural lesion (1.6%)
Unrelated to the Misonix Bone Scalpel:
- one case of blood loss greater than 500 ml (1.6%),
- three iatrogenic dural lesions (4.8 %),
- two wound infections (3.2%),
- two cases where worsening of neurology was observed,
- one patient undergoing laminoplasty suffered a C5 root lesion.
19 Bydon, M; Macki, M; Xu, R; Ain, MC; Ahn, ES; Jallo, GI. Spinal decompression in
achondroplastic patients using high-speed drill versus ultrasonic bone curette: technical note
and outcomes in 30 cases. J Pediatr Orthop. 2014;34(8):780-6.

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The purpose of this retrospective study was to compare risks and benefits in performing a
multilevel thoracolumbar decompression of the achondroplastic spine in pediatric patients
using either the conventional high-speed drill or the Misonix BoneScalpel. reviewing
surgical outcomes in 30 decompressions performed. To explore the BoneScalpel utility in
complex spine surgeries, surgeons randomly assigned the ultrasonic bone curette to
achondroplastic decompressions, thereby eliminating selection biases. Only surgeons who
specialized in spinal decompressions on achondroplastic spines utilized the BoneScalpel,
thereby eliminating operator-dependent biases. The sample population was retrospectively
divided into a high-speed drill cohort and a BoneScalpel cohort. The high-speed drill was
used in 20 cases (66.7%), whereas the BoneScalpel was used in 10 cases (33.3%). The cases
included 15 (50.0%) revision surgeries and 15 (50.0%) first time operations. Of the 15
reoperations, 1 was observed in the BoneScalpel cohort. Of the 30 patients, 70.0% were
male (n=21). Patient age, mean follow-up time, mean length of hospital stay were not
significantly different between the two groups, but the number of level decompressed was
higher (5.5 vs. 3) in the high-speed drill group. The number of fused levels (6) was not
significantly different. The pre ad post-operative gravity of symptoms (sensory disturbances,
back pain, incontinence, neurogenic claudication, radiculopathy, ataxia and weakness). In
the high-speed drill group, pre- vs. post-operative differences in sensory disturbances, back
pain, incontinence, and neurogenic claudication reached all statistical significance. In the
ultrasonic bone curette group, improvement in neurogenic claudication and weakness
reached statistical significance. In comparison with the high-speed drill cohort, the
BoneScalpel cohort experienced less overall perioperative complications, including
durotomy, cerebrospinal fluid leak, pseudomeningoceles, wound infection, and wound
dehiscence. 45.0% of patients experienced a durotomy in the high-speed drill cohort but only
30.0% of patients experienced a durotomy in the BoneScalpel cohort. Complications are
reported in the paragraphs that follows.

Positive clinical results/positive outcomes: N/A


- A decreased number of durotomies as well as a decreased total number of
complications was observed in the BoneScalpel cohort versus the high-speed drill
cohort.
Complications/negative outcomes:
Complications were as follows:
Durotomy CSF Leak Pseudomeningocele Wound infection Wound
dehiscence

High-speed drill 9 (45%) 2 (10%) 1 (5%) 2 (10%) 1 (5%)

Bone Scalpel 3 (30%) 0 0 0 0

In the Bone Scalpel group, the device was responsible for only one of the durotomies, the
remaining two being caused by other surgical instruments.
Other comments:

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None
20 Pakzaban, P. Ultrasonic total uncinectomy: a novel technique for complete anterior
decompression of cervical nerve roots. Neurosurgery. 2014;10 Suppl 4():535-41; discussion
541.
This work describes a case series, without control group, involving 38 patients with cervical
radiculopathy or myeloradiculopathy. The patients’ mean age was 65 years (range, 43-80
years). There were 17 men and 21 women. Mean follow-up was 28± 7 weeks (range, 14-37
weeks). All patients had neck pain and a significant cervical radiculopathy. Fifteen patients
(40%) had arm weakness (including 3 with complete deltoid paralysis), and 6 patients (16%)
had a superimposed myelopathy. underwent single-level or multilevel ACDF (Anterior
Cervical Diskectomy and Fusion) in combination with single-level or multi-level UTU
(ultrasonic total uncinectomy ). No bilateral uncinectomies were performed. Six patients had
2-level UTUs. A standard anterior cervical diskectomy was performed at 1 or multiple levels.
The posterior osteophytes were drilled away centrally up to the medial aspect of the
uncinate process on each side. The posterior longitudinal ligament was resected to expose
the dura. At the level and side targeted for total uncinectomy, the longus coli muscle was
dissected away from the anterolateral surface of the adjacent vertebral bodies and uncinate
process such that a Penfield 4 instrument could be gently wedged lateral to the uncinate
process. The Misonix BoneScalpel, Misonix, Inc) was used to amputate the base of the
uncinate process flush with the superior endplate. In this step, the microshaver was moved
in repeated brushstrokes in a posterior-toanterior direction, originating at the depth of the
uncinate process where the blunt tip of the microshaver was allowed to come in brief
contact with the nerve root and the lateral epidural veins. After the lateral cortical margin of
the uncinate process was reached, the uncinate process consistently became mobile. Then a
Penfield 4 instrument passed lateral to the uncinate process was used to fold the uncinate
process into the disk space. At this stage, the tip of the uncinate process remained attached
to the upper vertebral body via the uncovertebral ligaments. The Penfield 4 was replaced
with a 2-0 curette to detach these ligaments and to mobilize the uncinate process medially
and remove it. The soft tissues overlying the nerve root were incised with a 1-mm Kerrison
rongeur or a microhook to fully expose the nerve root all the way to the medial margin of
the vertebral artery. Fusion with iliac crest allograft and plating with a plate were performed
in standard fashion. All patients were observed in the hospital overnight and discharged
within 24 hours. All patients wore a soft cervical collar for 1 month postoperatively. Patients
were examined at 1 and 6 weeks postoperatively (and as needed thereafter), and underwent
dynamic cervical radiographs at 6 weeks and 6 months postoperatively (and as needed
thereafter) in accordance with the author’s routine practice. Within the limited follow-up
period of the study, 17 patients had solid fusion, and the remaining 21 patients had
satisfactory progress toward fusion. Of the 17 patients with solid fusion, 6 had satisfactory
progress toward fusion at 6 months and went on to develop solid fusion at 9 to 12 months.

Positive clinical results/positive outcomes


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- No patients developed hardware failure, resorption of the bone graft, or gross
instability within the follow-up period
- no instances of vertebral artery injury or nerve root injury were observed.

Complications/negative outcomes
- Complications were 1 wound erythema (2.6%), 3 transient cases of mild hoarseness
(7.9%) and 2 cases of dysphagia after 6 weeks (5.2%).
- These minor complications were similar to those experienced with standard ACDF
- None of them was related to the use of the ultrasonic device

Other comments:
additional irrigation was used to supplement the built-in one as authors were highly
concerned of overheating
21 Al-Mahfoudh, R; Mitchell, PS; Wilby, M; Crooks, D; Barrett, C; Pillay, R; Pigott, T.
Management of Giant Calcified Thoracic Disks and Description of the Trench Vertebrectomy
Technique. Global Spine J. 2016;6(6):584-91.
In this case series, 29 cases of herniated thoracic disk with pain and paresthesia, weakness,
thoracic back pain are described. Of these 29 cases, 18 patients had giant calcified thoracic
disks,ndefined as diffusely calcified disks occupying at least 40% of the spinal canal, requiring
special neurosurgical consideration owing to significant involvement of the spinal canal and
compression of the spinal cord, often leading to myelopathy. Of the 18 cases of giant
calcified thoracic disks, Thoracotomy was performed on 17 (94.4%) patients, and 1 (5.6%)
patient had a costotransverse approach. A trench vertebrectomy was performed with half of
vertebra on either side excised. The ultrasonic bone cutter was useful here as an alternative
to piecemeal resection or using a pneumatic drill. Although GCTDs (Giant Calcified Thoracic
Disks) are difficult neurosurgical challenges, excellent fusion rates were achieved in this case
series with insertion of rib head autograft in the trench with the help of the ultrasonic bone
cutter.
Positive clinical results/positive outcomes
Fifteen (83.3%) patients experienced a postoperative improvement of at least 1 point in the
mJOA (Japanese Orthopaedic Association) score on last follow-up. The remaining three
patients’ mJOA scores remained at least unchanged. These results are encouraging. There
was no surgical mortality and none of the patients experienced neurologic decline.

Complications/negative outcomes
Postoperative complications included cerebrospinal fluid leak in 2 patients (11.1%). This
complication was identified and repaired intraoperatively with no further sequelae. Six
(33.3%) patients required a blood transfusion during their hospital stay. One (5.6%) patient
was transferred to the intensive care unit for ventilatory support due to development of

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adult respiratory distress syndrome. The patients recovered well.

Other comments:
The complications were not device-related.
About Mectron Piezosurgery
22 Hoigne, DJ; Stübinger, S; Von Kaenel, O; Shamdasani, S; Hasenboehler, P. Piezoelectric
osteotomy in hand surgery: first experiences with a new technique. BMC Musculoskelet
Disord. 2006;7():36.
This reference reports the case of 23-years old man who presented with a malunited
metacarpal bone fracture of the fifth finger on his dominant hand, causing a 45 degree
angular deformity of the fifth metacarpal neck with internal rotation. A treatment plan was
designed calling for a correctional osteotomy of the 5th metacarpal bone. A longitudinal
incision was made over the fifth metacarpal. The tendon of the extensor digiti minimi was
found and on its radial side the periosteum of metacarpal five was reached. The periosteum
was opened longitudinally over the defect as usual. For the correction of the defect of 45
degrees, a bone wedge was excised. Instead of using the traditional oscillating saw, the
Piezosurgery Devicewas used. A sharp hardened saw coated with titannitrid was used at the
higher power level with automatic irrigation cooling at its maximum level. Angulation and
rotation were corrected and bone extremities fixed with a 1.5 mm titanium five-hole plate
and four screws. Closure of the wound was done in layers. Mobilization was started on the
10th postoperative day. The postoperative healing of the wound and the bone consolidation
were smooth and recovery shorter than what is usually observed in these cases. The patient
regained full use of his finger according to the state before the fracture. 12 months after
results were still satisfactory.

Positive clinical results/positive outcomes


- The patient as well as the surgeons were fully satisfied with the result.
- The device showed to be an optimum for hand surgery: the cut was highly precise and
there were no vibrations of the bone.
Complications/negative outcomes
- None: at no point was there any loss of sensitivity and nor any neurovascular
disturbances.
Other comments:
None
23 Kramer, FJ; Ludwig, HC; Materna, T; Gruber, R; Merten, HA; Schliephake, H. Piezoelectric
osteotomies in craniofacial procedures: a series of 15 pediatric patients. Technical note. J

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Neurosurg. 2006;104(1 Suppl):68-71.
The study aimed to investigate the usefulness of the Piezosurgery device in pediatric
craniofacial surgery for frontoorbital advancement. Patients (mean age 11.3 months) were
15 children affected by syndromic or non-syndromic craniosynostosis. The frontoorbital
segment was osteotomized using Piezosurgery. All ultrasonic osteotomies were performed
under intense and continuous irrigation with a sterile 0.9% sodium chloride solution that was
cooled to 4° before application. Piezosurgery was also used to shape the osteotomized bars
before replantation. During the 12 months follow up postoperative bone formation was
uneventful in all patients.
Positive clinical results/positive outcomes
- The device was precise and easy
- Low pressure only was needed to perform osteotomy
- The limited amount of vibrations (with respect to conventional reciprocating saws)
made cutting and handling easier
- Exposure of bone surfaces was less extensive (same) reducing surgical trauma

Complications/negative outcomes
- none along the 12-month follow-up period

Other comments:
- authors stress the need for continuous and intense irrigation of the osteotomy site.
24 Gleizal, A; Bera, JC; Lavandier, B; Beziat, JL. Piezoelectric osteotomy: a new technique for
bone surgery-advantages in craniofacial surgery. Childs Nerv Syst. 2007;23(5):509-13.
This non-randomized, prospective clinical trial describes the use of the Piezosurgery device in
different craniofacial surgical procedures. Patients distribution was as follows: a) 30 cases of
craniofaciostenosis (15 trigonocephaly, 15 plagiocephaly) requiring superior orbital removal;
b) 2 patients with Crouzon syndrome requiring Le Fort III osteotomy; c) 30 cases of
craniofaciostenosis (trigonocephaly and plagiocephaly), requiring parietal and frontal bone
cut. The median age was 6.2 months for the group of craniostenostosis treated with the
piezoelectric device and 6.4 months for the mechanical group. The ultrasonic device was 1.
to remove the superior orbital roof in cases of craniofaciostenosis, 2. to perform the Le Fort
III osteotomy on the two patients affected by the Crouzon syndrome in two patients, 3. to
cut the parietal and frontal bone in cases of craniofaciostenosis. Different types of
information were collected including: 1. the duration of time for each bone cut (this does not
include the repair of the dura tear, in case of dura mater injuries), 2. the absence of injury to
the dura mater and globe after the removal of the roof or external wall of the orbit, 3. the
absence of injury to the dura mater and brain tissues after the removal of the parietal and
frontal bone cutting. All results were compared to those observed in cases using mechanical
bone sectioning (15 trigonocephaly, 15 plagiocephaly, 2 Le Fort III osteotomies, 20 cases of
parietal unicortical bone graft). Functional results were good without any soft tissue damage
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appreciated. The overall operative time, however, was increased with piezoelectric surgery.
The results appear in favour of piezoelectric osteotomy for craniofacial indications (removal
of the orbital roof), whereas craniotomy does not appear to benefit from this new tool (two
cases of dura mater injuries and augmentation of the operative time).

Positive clinical results/positive outcomes


- Functional results were good without any soft tissue damage appreciated.
Complications/negative outcomes
Related to the Piezosurgery device:
- During the removal of the frontal and the parietal bone, there were two cases of dura
mater injuries. In these two cases (out of 30, corresponding to 6.7%), the
craniofaciostenosis were very advanced and the dura mater was adherent to the bone,
so the piezoelectric device cut both dura mater and bone.
Unrelated to the Piezosurgery device:
- two small orbital wounds and one small dura mater injury, without any consequences,
in the mechanical group treated for craniofaciostenosis
Other comments:
Authors note an increase in cutting time when Piezosurgery was used. However, the
cumulative time for surgery was not significantly different between ultrasonic piezosurgery
and mechanical cutting because the lack of soft tissue injury and the very precise nature of
the osteotomy lend to shorter subsequent operative times.
25 Salami, A; Dellepiane, M; Proto, E; Mora, R. Piezosurgery in otologic surgery: four years of
experience. Otolaryngol Head Neck Surg. 2009;140(3):412-8.
A prospective study is described, involving 133 patients affected by different pathologies of
the ear: 50 patients affected by otosclerosis, 50 cases of chronic otitis media, 20 cases of
posttraumatic facial nerve palsy, 10 cases of type A glomus tympanicum tumor and 3 cases
with a B-cell non-Hodgkin lymphoma. The patients affected by otosclerosis required
stapedotomy, patients with chronic otitis required intact canal wall tympanoplasty (to
achieve the complete eradication of middle ear pathology such as acquired cholesteatoma),
patients with a posttraumatic facial palsy required complete skeletonization of the canal
facial nerve and decompression in its tympanic segment, and patients with middle ear
tumors required complete excision of the mass. In each surgical technique, Piezosurgery was
used in many intraoperative steps requiring bone cutting, with specific inserts.
Postoperatively, all patients had an uneventful recovery with no evidence of sensorineural
hearing loss, tinnitus, neural deficit, or side effects (there were no complications during the
peri- or postoperative period).

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Positive clinical results/positive outcomes
- In each surgical technique, the Mectron Piezosurgery device provided excellent control
without side effects on the adjacent structures of the middle and inner ear.
- Metron Piezosurgery provideded a blood-free operative area because of cavitation
from the irrigation solution caused by the ultrasonic microvibration.
- Audiologic data confirmed safety of the device on the anatomic structures of the inner
and middle ear.
Complications/negative outcomes
- none
Other comments:
- none
26 Salami, A; Mora, R; Dellepiane, M; Guastini, L. Piezosurgery for removal of symptomatic ear
osteoma. Eur Arch Otorhinolaryngol. 2010;267(10):1527-30.
This prospective study was performed to investigate the effectiveness of Mectron
Piezosurgery in in the excision of symptomatic ear osteomas. Ten patients were enrolled
(mean age 43.4, range 21-58 years, 7 males, 3 females). The patients presented a conductive
hearing impairment, on the affected side, with moderate otalgia. In each patient, the
physical examination revealed that the EAC was completely occluded by a hard mass, which
was fixed and covered with the skin; the temporal bone computed tomographic scan showed
a bony mass filling the bony EAC. All patients were submitted to complete excision of the
mass using the Mectron Piezosurgery. The piezoelectric device was used in all intraoperative
steps, with specific inserts. The osteoma was removed en bloc. In all patients it was possible
to preserve the bony ear canal wall of the EAC without side effects to the facial nerve and/ or
tympanic membrane and/or temporomandibular joint. Before and 6 months after surgery,
all the patients underwent the following instrumental examinations: pure-tone audiometry,
tympanometry, transient-evoked optoacoustic emissions (TEOAE) with linear click emission,
distortion product otoacoustic emissions (DPOAEs), auditory brainstem response (ABR) by
MK 12-ABR screener with natus-ALGO2e. Patients presented a significant (p < 0.05) recovery
of their conductive hearing loss The mean postoperative interval for healing was 2.50 weeks
and 100% were healed after 3 weeks. Healing was uneventful. The author observed no
recurrence or complications along the 6 months follow up period after surgery.
Positive clinical results/positive outcomes
- Surgical steps could be performed with precision, easy intraoperative management,
and safety
Complications/negative outcomes
- no side effects were observed to the facial nerve/tympanic
membrane/temporomandibular joint
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- no sensorineural hearing loss, tinnitus, neural deficit, or side effects were osserved
post-operatively
Other comments:
- none
27 Salami, A; Mora, R; Dellepiane, M; Crippa, B; Guastini, L. Results of revision mastoidectomy
with Piezosurgery(®). Acta Otolaryngol. 2010;130(10):1119-24.
This investigation was a prospective study, involving 30 patients who had revision
mastoidectomy with or without cholesteatoma. Patients were aged between 36 and 72 years
(mean 58.2 years). There were 18 females and 13 males. Causes of re-admission of the
patients were ear discharge in 17 patients, earache in 9 patients, and vertigo in 4 patients.
Patients were treated through revision mastoidectomy with previous canal wall up
mastoidectomy. The time interval between revision mastoidectomy and previous surgery
was 1–16 years (mean 6.4 years). There were no cases of bilateral diseased ears; 18 right
ears (60%) and 12 left ears (40%) were affected. Previous surgery had been performed with
traditional (non-ultrasonic) devices. Before and 1 year after surgery, all the patients
underwent the following instrumental examinations: pure-tone audiometry, tympanometry,
transientevoked otoacoustic emissions (TEOAEs) with linear click emission, distortion
product otoacoustic emissions (DPOAEs), auditory brainstem response (ABR) by MK 12-ABR
screener with natus-ALGO2e and electronystagmographic (ENG) recording. On surgery, the
Mectron Piezosurgery device was used in all intraoperative steps, using the tip more
adequate for the surgical step to be carried out. Success was experienced in all surgical
steps, with the Piezosurgery device allowing to remove all of the diseased air cells during
mastoidectomy; to remove the excess bone from the auditory canal during canaloplasty and
to open and clean the supratubal recess. Postoperatively, all patients had an uneventful
recovery with no evidence of sensorineural hearing loss, tinnitus, neural deficit, or side
effects.
Positive clinical results/positive outcomes
- during unintentional contact with the facial nerve, lateral sinus, and dura mater, no
patient experienced side effects.
- Metron Piezosurgery provideded a blood-free operative area because of cavitation
from the irrigation solution caused by the ultrasonic microvibration
- Audiologic data confirmed safety of the device on the anatomic structures of the inner
and middle ear
Complications/negative outcomes
- Intermittent otorrhea with perforation of the tympanic membrane occurred in one
patient (3%) during follow-up. This complication was not related to the use of the
device.
Other comments:
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none
28 Salami, A; Mora, R; Dellepiane, M; Crippa, B; Santomauro, V; Guastini, L. Piezosurgery versus
microdrill in intact canal wall mastoidectomy. Eur Arch Otorhinolaryngol. 2010;267(11):1705-
11.
The objectives of this study was to report the authors’ experience with Mectron Piezosurgery
in the intact canal mastoidectomy, evaluating its effectiveness and comparing the results
with those achievable using a microdrill. The study was a non-randomized controlled trial,
involving 60 patients. The follow-up period was 12 months. The patients (26 males and 34
females), aged between 34 and 67 years, were divided into two numerically equal and
homogeneous groups (group A: treated with piezoelectric device, group B: treated with
microdrill). All the patients presented a chronic active otitis media with pain, hearing loss,
constant otorrhea, and perforation in the tympanic membrane on the affected side.
Preoperative CT scan revealed a cholesteatoma of the meso- and hypotympanum, involving
the ossicular chain and the mastoid cells. No patients presented facial nerve or other
neuropathies or vestibular symptoms. All patients were subjected to intact canal wall
mastoidectomy, either using Mectron Piezosurgery or a microdrill. All patients were
subjected, before and 1 year after surgery to the following tests: otomicroscopic evaluation
of the tympanic membrane and external auditory duct, bone conduction threshold
audiometry, tympanometry, transientevoked otoacoustic emissions (TEOAEs), distortion
product otoacoustic emissions (DPOAEs), auditory brainstem response (ABR), and
electronystamographic (ENG) recording. Average operation time was not significantly
different between the two groups, but average hospital stage was significantly smaller the
group of patients operated using the Mectron Piezosurgery device (3.1 vs. 4.1 days). In both
groups, one year after surgery, no worsening of all audiometric parameters was observed. At
one year audiometric parameters were not significantly different between the two groups.

Positive clinical results/positive outcomes


- Audiologic data confirmed safety of the device on the anatomic structures of the inner
and middle ear

Complications/negative outcomes
- Intermittent otorrhea with perforation of the tympanic membrane occurred in one
patient (3%) in the Piezosurgery group and 3 patients (10%) in the microdrill group.
- The complication in the Piezosurgery group was not related to the use of the device.
Other comments:
- none
29 Crippa, B; Salzano, FA; Mora, R; Dellepiane, M; Salami, A; Guastini, L. Comparison of
postoperative pain: piezoelectric device versus microdrill. Eur Arch Otorhinolaryngol.
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2011;268(9):1279-82.
This paper aimed to assess differences if any in severity of pain in the first 10 post-operative
days in patients having a mastoidectomy of the intact canal wall performed using a
ultrasonic bone cutter (Piezosurgery, 70 patients, 45.2 years old on average) or a microdrill
(70 patients, 46.6 years old on average). All patients presented a chronic active otitis media
with pain, hearing loss, constant otorrhea, and perforation in the tympanic membrane on
the affected side. No patients presented facial nerve or other neuropathies or vestibular
symptoms. Exclusion criteria were considered all the patients with an history of otologic
surgery, diabetes, immunosuppression, allergic rhinosinusitis, psychiatric illness, regular use
of narcotics, known allergy, or contraindication to local or systemic analgesics (paracetamol,
non-steroidal anti-inflammatory drugs such as salicylates and opioid drugs). Patients
underwent pain evaluation using a VAS scale 24 h, 3 and 10 days after the surgery. Severity
was recorded as null (VAS=0), slight (VAS 1-4); moderate (VAS 5-7) and severe (VAS 8-10).
The use of Piezosurgery changed significantly the short-term post-operative perception of
pain: at day 1 and 3, in fact, a significantly greater number of patients treated using
piezosurgery experienced slight or moderate pain than those treated using the microdrill. At
10 days no significant difference in pain perception was observed between the two groups.
At days 1 and 3 patients treated with Piezosurgery were taking a significant smaller amount
of analgesics than patients treated with the microdrill. At 10 days the difference was no
more statistically significant. Authors conclude that the significant smaller pain experienced
by patients treated using Piezosurgery could be due to less overheating and the specific
characteristics of ultrasonic vibration that together with irrigation help evacuating debris
from the surgical site, so eliminating a possible cause of topic inflammation.
Positive clinical results/positive outcomes:
- Patients operated using the Piezosurgery experienced significantly less pain than those
treated with a micro-drill.
- Some characteristics of the ultrasonic device (the fact that ultrasonic vibration when in
contact with the irrigation fluid creates an aerosol that facilitates cleaning the local
micro-environment) might create a condition that favours early remission of
inflammation.
Complications/negative outcomes:
None reported.
30 Grauvogel, J; Scheiwe, C; Kaminsky, J. Use of piezosurgery for internal auditory canal drilling
in acoustic neuroma surgery. Acta Neurochir (Wien). 2011;153(10):1941-7; discussion 1947.
The paper describes a retrospective analysis of the outcome of Piezosurgery in eight patients
who were treated for internal auditory canal opening in acoustic neuroma surgical
treatment. All 8 patients affected by Acoustic Neuroma from T1 to T4. Neuropathological
diagnosis was schwannoma, WHO grade I for all patients. Operations were done through
retromastoid craniectomy. The piezosurgical device was used to cut the bony wall of the IAC

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and the remainder of the bone around the tumor parts and cranial nerves using proper
inserts. All tumors were completely resected with anatomic preservation of the facial and
cochlear nerve. Patients were evaluated before and three months after surgery a) for facial
nerve function according to the House and Brackmann grading system and b) using pure
tone audiometry (PTA) and speech discrimination score (SDS). All tumors were completely
removed. Complete resection of AN tumor was confirmed by independently assessed MRI
scan 3 months after surgery.

Positive clinical results/positive outcomes


- in all cases the intrameatal part of the dura around the seventh and eighth nerves could
be preserved during the cutting process confirming the device prevent soft-tissue
damages
- intra-operative electrophysiological monitoring remained constant throughout the
surgery, showing nerves were not affected by the procedure
- bone could be removed layer by layer in a shaping fashion with limited pressure and
without performing dangerous rotations
Complications/negative outcomes:
None
Other comments:
None
31 Heredero Jung, S; Dean Ferrer, A; Solivera Vela, J; Alamillos Granados, F. Spheno-orbital
meningioma resection and reconstruction: the role of piezosurgery and premolded titanium
mesh. Craniomaxillofac Trauma Reconstr. 2011;4(4):193-200.
This work reports the case of 52-years old woman, affected by a spheno-orbital meningioma
presenting a left, slowly progressive, non-pulsating, irreducible proptosis. Histological
evaluation of the specimen showed infiltration, in both the dura mater and the resected
bone, by a grade I meningothelial meningioma. Complete resection was performed by means
of a frontotemporal craniotomy and an orbitozygomatic approach. Osteotomy using
Piezosurgery was performed around the optic nerve canal and the superior orbital fissure to
minimize the damage to soft tissues. Piezosurgery was also used in frontal, supraorbital rim,
and subcranial osteotomies. Orbital wall reconstruction was done using a titanium mesh
previously premolded using a skull model. The superior orbital rim was reconstructed with
calvarial bone grafts, and the sphenotemporal bone defect was covered with a titanium
mesh cranioplasty. Complete resection of the tumor with good functional and cosmetic
results were achieved correcting proptosis.
Positive clinical results/positive outcomes
- Complete tumor resection and good functional/esthetic results were achieved and
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maintained at the 12 month follow-up
Complications/negative outcomes
None
Other comments:
None
32 Mancini, G; Buonaccorsi, S; Reale, G; Tedaldi, M. Application of piezoelectric device in
endoscopic sinus surgery. J Craniofac Surg. 2012;23(6):1736-40.
This paper describes a prospective case series involving recruiting patients suffering from
rhinogenous headache, rhinorrhea, nasal obstruction, and sinusitis not having polyposis.
Four patients, mean age 55 years (48-63), were recruited. Two had a septal deviation and a
concha bullosa, a patient had a septal deviation and an ethmoidal bulla deterioration and
one patient had an osteomeatal complex obstruction and a maxillary sinusitis. All patients
were subjected to transnasal endoscopic osteotomy and osteoplasty using the Piezosurgery
device. In particular, the technique was applied in maxillary antrostomy as an access way to
the sinus, in the calibration of frontal recess, in the opening of ethmoid bulla, in the plastic of
middle turbinate concha bullosa, and in the submucous resection of the osteocartilaginous
septum. In 1 out of 4 cases it was necessary to expand the infundibulum and frontal ostium
to improve ventilation of the sinus. Patients were followed up for at 3, 6, and 9 weeks and 6
and 9 months. Patients healed uneventfully and there were no major or minor
complications, in immediate or long-term postoperative period.
Positive clinical results/positive outcomes
- The author managed to preserve the mucosa, thanks to the piezo technology;
- in nasal septum resection, the piezosurgery technique allowed to not access and detach
in the contralateral part to the septal deviation, thus promoting a faster and better
healing
- The device allowed for precise and selected cutting of bone and cartilage

Complications/negative outcomes
None along the 9-month follow-up
Other comments:
None
33 Grauvogel, J; Scheiwe, C; Kaminsky, J. Use of Piezosurgery for removal of retrovertebral body
osteophytes in anterior cervical discectomy. Spine J. 2014;14(4):628-36.
This prospective clinical study describes the treatment of 9 patients (five female and four
male) with symptoms of either cervical radiculopathy or cervical myelopathy resulting from
soft or hard disc herniation and retrospondylar osteophytes causing spinal nerve or spinal
cord compression. Protocols of anterior cervical discectomy with fusion (ACDF) surgery were

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applied. Piezosurgery was supportively used in ACDF in nine patients with either
radiculopathy or myelopathy from disc herniation or ventral osteophytes. After discectomy,
osteophytes were removed with Piezosurgery to decompress the spinal canal and the
foramina. Angled inserts were used, allowing for cutting even retrovertebral osteophytes. In
all nine cases, Piezosurgery cut bone selectively with no damage to nerve roots, dura, or
posterior longitudinal ligament. None of the patients experienced any new neurological
deficit after the operation. The handling of the instrument was safe and the cut precise.
Osteophytic spurs, even retrovertebral ones that generally only can be approached via
corpectomies, could be safely removed because of the angled inserts through the disc space.

Positive clinical results/positive outcomes

The angled inserts were effective in cutting bone spurs behind the adjacent vertebra which
cannot be reached with conventional rotating burs. There were no postoperative
complications such as hoarseness, hematoma, infection, or cerebrospinal fluid fistula in our
patient group. Postoperative radiographs of the cervical spine also showed no complications
at the site of the implant.

Complications/negative outcomes

A slightly prolonged operation time was observed for Piezosurgery. Furthermore, the design
of the handpiece could be further improved to facilitate the intraoperative handling in ACDF.

Other comments

In this study two Mectron devices were used. In the first seven cases, a device called
Piezosurgery II, and in the other two cases a more sophisticated device, the Piezosurgery
medical were used. The more powerful Piezosurgery medical device was specially
constructed for neurosurgical and orthopedic use, whereas the Piezosurgery II device was
originally designed for use in dental and maxillofacial surgery. Both instruments showed to
be safe and effective.

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Analysis of clinical data

Summary of conformity assessment with requirement on safety (MDD ER1 / AIMDD


ER1).

When the Oscar device was used for bone cement removal, the only complication observed was
related to overheating, as described by Goldberg, 2005 (3). Goldberg investigated the matter more
in depth, through a cadaver study, again described in (3), observing how overheating was strictly
dependent by the presence or absence of irrigation, with irrigation effectively decreasing heating
into acceptable ranges. Brooks et al., (1993) (7) again observed in cadaver studies that heating
may be effectively reduced by proper irrigation. Ultrasonic devices seem to be quite easy to
handle, as only once a complication was observed because of improper connection of the tool to
the handpiece as described in de Steiger et al., 1996 (9). Other device-related complications are
quite scarce. The study of van-Diemen et al. (13), for example, describes a routine use of an
equivalent device in removing bone cement during resection arthroplasty, on 136 patients, not
provide any specific feedback as bone cement removal was just an intermediate step of surgery.
This may implicitly imply that the device did not cause any intra-operative complications. No post-
operative device related complications were observed in the same study. When equivalent devices
were used for bone cutting, in other fields than Orthopaedics, the rate of general complications
was in all cases within the same range of that observed when non-ultrasonic instruments were
applied. Studies on ear surgery – where auditory nerves are strictly close to bone subjected to
osteotomy, confirm indirectly that, with proper irrigation, no overheating and consequent damage
is observed as the patient’s audiologic functional parameters don’t suffer any significant decrease.
In general, all authors stress the importance of constant and abundant irrigation. In Neurosurgery,
the only rare complications observed were dural perforations, whose rate (<10%) was within the
range observed with non-ultrasonic instruments.

A description of the study methods and results and a list of all complications observed in the
studies, including the ones that were not related to the use of the piezoelectric instruments, are
available in Annex I. The table below provides the list only of complications that were related to
the use of the medical devices.

All the complications that have been reported in the clinical data assessed that concerned
orthopaedic applications are adequately addressed in the device IFU (see table below).

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Ref. Medical N patients Indication Complications associated with the Notes
device treated ultrasonic device
with the
device
(3) Oscar One Cement removal Necrosis of muscle, cortical bone and nerve Thermal damage can be minimized by proper irrigation and education of surgeons with regard
patient. from the humerus tissue, probably due to overheating, provoking to proper techniques.
The study both a radial nerve palsy and indirectly a The importance of training and irrigation are adequately described in the IFU of the Oscar
also pathologic humeral fracture. device (see Section 3 or IFU, Annex B).
included
six human Warnings and Cautions
cadaveric “This device should only be used by qualified surgeons who are (1) suitably trained in the
specimens arthroplasty revision surgery procedures that are to be carried out and (2) trained in the
specific use of ultrasonic surgical instruments intended for use during arthroplasty revision.”

Safety precautions – OSCAR Handset Cement Remover


“Intensive use of Cement Removal Handset can cause warming of handset body. In such
situations, the user is advised either to increase the cooling time allowed, or to use a second
Cement Removal handset. In case of intensive use these are the potential temperature
reachable by handset:
• Cement Removal Handset (normal condition): 55 °C
• Osteotome Handset (normal condition): 47 °C
• Cement Removal Handset (single fault condition): 64 °C”

Safety precautions - Irrigation during cement removal


“Irrigation of the bone canal following a period of cement removal is important for two reasons.
Firstly, it clears the canal of cement debris and secondly it maintains safe operating
temperatures. It is recommended that irrigation, in the form of pulsed lavage or manual
irrigation, is used intermittently following use of the scrapers or groover probes and that the
frequency of irrigation is more frequent when using the piercer probes.
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Ref. Medical N patients Indication Complications associated with the Notes
device treated ultrasonic device
with the
device
It is recommended that irrigation is used more frequently in the following instances:
1. Cement removal in the upper extremity limbs
2. Knee revisions
3. Cases of femoral cortices which are particularly thin”
(9) Biomet Ultra- 1 Cement removal in Femur perforation caused by wrong assembly In order to reduce complications associated with device misuse, the instrument should be
drive hip arthroplasty of the device individual components. Two- used by qualified and trained surgeons. This is stated in IFU (see note above)
revision months after surgery the patient was
comfortably partially weight bearing and the
osteotomy site was united well.
(14) Misonix 88 Bone cutting in Patients treated using an ultrasonic bone According to authors, this significant difference may be attributed to the fact that a statistically
Ultrasonic patients requiring curette tended to have a longer hospital length higher number of metastatic tumor cases (p < 0.0001) were present in the BoneScalpel cohort,
BoneScalpel posterior of stay than those who received the high-speed likely increasing the LOS for that patient population.
decompression of drill (median of 5 vs 6 days).
the cervical or
thoracic spine
(15) Misonix 128 Bone cutting in 2 cases of dural injuries. In one case, the To avoid this complication, the authors suggest that surgeons who are new to the technique to
Ultrasonic spine surgery authors report that the incident derived from use particular care to avoid local temperature increases from the frictional effects. Generous
BoneScalpel overheating of the local tissue by the scalpel irrigation should be applied to achieve effective cooling.
blade sitting in one position.
(17) Misonix 40 Osteoplastic 1 case (2.5%) of incidental durotomy. It The authors conclude that the device is safe as the complication rate was low. Again, as
Ultrasonic laminoplasty in the resulted in no neurological injury and was discussed above, care in using the device is required for less experienced surgeons.
BoneScalpel resection of repaired primarily without subsequent
intradural spinal cerebrospinal fluid leakage. This occurred
pathology during the user’s first experience with the
device and was a heat-related defect
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Ref. Medical N patients Indication Complications associated with the Notes
device treated ultrasonic device
with the
device
(18) Misonix 62 Bone cutting in 1 case (1.6%) of dural lesion. A low risk of dural lesion remains associated with the use of the device. However, according to
Ultrasonic spinal surgey authors, this risk can be considered low as in literature the incidence of dural tears ranges
BoneScalpel from 1.6% to 9%.
(19) Misonix 10 Spinal In the study, 45.0% of patients experienced a The device does not prevent the risk of durotomies, but their incidence is lower than what
Ultrasonic Decompression in durotomy in the high-speed drill cohort but only observed with alternative bone cutting methods.
BoneScalpel Achondroplastic 30.0% of patients experienced a durotomy in
Patients the BoneScalpel cohort. The ultrasonic curette
was responibile only for one of these (10%).
(24) Mectron 30 Craniofacial and Two cases (6.7%) of dura mater injuries in According to authors, the piezoelectric surgery may be more indicated for same types of
7 Piezosurgery craniotomy surgery procedures of craniotomy. In these two cases, operations; while they observed excellent results in craniotomy surgery, craniotomy does not
the craniofaciostenosis were very advanced appear to benefit from the use of this device.
and the dura mater was adherent to the bone,
so the piezoelectric device cut both dura mater
and bone.

In conclusion, there is consistency between current knowledge, the available clinical data, the information materials supplied by the
manufacturer, and the risk management documentation for the device.

According to our clinical evaluation, the requirement of safety of the Oscar device is satisfied.

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Summary of conformity assessment with requirement on acceptable benefit/risk profile
(MDD ER1 / AIMDD ER1).

An in-depth analysis of the identified hazards and benefits reported in the studies analyzed is
provided in Annex I.
As outlined in the preceding Section, the only serious adverse event observed was necrosis
of muscle, cortical bone and nerve tissue, probably due to overheating, provoking both a radial
nerve palsy and indirectly a pathologic humeral fracture in a patient. The risk of thermal damage
can be considered acceptable in lights of the several benefits associated with the use of the device
(see below) and of the fact that this type of hazard can be prevented using adequate surgical
knowledge and irrigation during the procedure.
Overall, the use of the Oscar device or of an equivalent piezoelectric instrument provided
definite benefits: the instruments allowed for precise and safe bone cutting and bone cement
removal. The use of the ultrasound technology allowed to minimize damage to bone and soft
tissues, to preserve bone stock, and to reduce bleeding, thus improving intraoperative visibility.
The authors also report describe good user manageability. The benefits described by the authors
of the studies are as follow:

Reference Device Benefits associated with the use of the piezoelectric device

(1) Smith Oscar Cement removal is atraumatic. The risk of plunging into the pelvis with a sharp instrument is
and Eyres, minimized. Damage to surrounding bone was avoided.
1999 Access to the cement was simple because the probes are thin and can be manoeuvred in
small spaces without difficulty.
Cement is an effective thermal insulator, and the controlled use of an ultrasonic tool in close
proximity to major organs is safe in respect to potential thermal injury.
Time-effective.
(2) Fletcher Oscar Oscar permitted easy removal of distal cement.
et al., 2000 The time needed to remove bone cement did not exceed 15 minutes; in several cases
cement removal was accomplished in less than five minutes.
The use of the Oscar device was significant in preserving bone stock by reducing the length
of the osteotomy.
It permitted the use of a shorter prosthesis in 60% of cases.
The warning signal incorporated within the system makes inadvertent penetration less likely
and thus may have contributed to the lack of perforations or cortical breaches.
(5) NICE, Oscar Specialist commentator comments:
2014 protect the bone by avoiding perforation or fracture.
Speed up the procedure.
Reduces the need for osteotomies.
Allows for use of shorter femoral prostheses, thus preserving distal femoral bone.
(6) Brooks et Biomet Ultra- Low risk of perforation
al., 1995 drive
(8) Klapper Biomet Ultra- Facile distal plug removal.
et al., 1992 drive Preserve proximal bone stock.
No cortical perforations.
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Safe and efficient.
Provides auditory feedback when removing cement from bone.
(12) Van Biomet Ultra- The entire osteotomy and stem extraction requires only 10 to 15 minutes.
Thiel et al., drive No compromise of proximal bone was observed
2011
(15) Hu et Misonix Reduction of bleeding which helps to create and maintain visibility in the surgical field.
al., 2013 Ultrasonic Osteotomy is performed in less time.
BoneScalpel If used properly, this device may decrease the risk of soft tissue injury.
(16) Nickele Misonix Safe and effective
et al., 2013 Ultrasonic Allows osteotomies without cutting or penetrating soft tissue.
BoneScalpel Leaves minimal bone defect.
Bony bleeding is kept to a minimum.
(17) Parker Misonix Cuts bone precisely.
et al., 2013 Ultrasonic Preserve underlying soft tissue.
BoneScalpel Ability to cauterize bleeding cancellous bone, thereby improving visualization.
Allows to greatly reduce the time required to perform the osteoplastic laminotomy (1 to 2
minutes per spinal level).
(18) Al- Misonix Reduces the time spent on operating.
Mahfoudh et Ultrasonic Reduces bone bleeding
al., 2014 BoneScalpel Protects spinal cord blood supply by preservation of radicular arteries in spite of a wide
trench decompression.
-Revision Lumbar decompressions: could be performed as a revision microdiscectomy, the device
aiding in creating a bony window and find “virgin” dura avoiding scar tissue. A similar principle is
applied in revision laminectomies.
-Laminoplasty: the ultrasonic bone scalpel could minimize neurovascular and soft tissue damage.
-Cervical corpectomy. the authors found the Misonix Bone Scalpel helpful to expedite this procedure
and minimise blood loss.
-Thoracic trench vertebrectomy: may accelerate the osteotomy while preserving the radicular vessels
and minimising blood loss.
-Lateral decompression of the lumbar canal: aids in removing bone up to the pedicle without the need
of an osteotome, for example exiting root decompression in conjunction with posterolateral
instrumented fusion.
(19) Bydon Misonix Lowering the durotomy and subsequent CSF leak rates, the BoneScalpel may also
et al., 2014 Ultrasonic decrease the rate of wound infections and dehiscence.
BoneScalpel Protects adjacent soft-tissue structures.
Allows for a shorter length of operation.
(20) Misonix The absence of a high-speed spinning burr eliminates the possibility of unwanted soft tissue
Pakzaban, Ultrasonic capture/injury and erratic drill movements.
2010 BoneScalpel The side-cutting surface can come in brief contact with the nerve roots and vertebral artery
without risk of injury.
Provides a smoother and more controlled surgical experience.
(21) Al- Misonix Allows all radicular arteries to be preserved, even those at the disk space level, thereby
Mahfoudh et Ultrasonic reducing the risk of spinal cord stroke secondary to ligation of the radicular artery of
al., 2016 BoneScalpel Adamkiewicz.
Spinal cord injury and dural tears are also less likely due to the selective tissue-cutting
properties of the ultrasonic bone cutter.
(22) Hoigne Mectron Allows highly precise bone cutting.
et al., 2006 Piezosurgery Absence of vibration in the area of operation is practical for operations using a magnifier.
The instrument can be moved in all directions comparable to a pen. The tip of the instrument
is exchangeable. Using the fine tip enables multiplanar as well as curved cutting. Because
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of the automatic water cooling during the whole procedure, there is always a clear view onto
the object.
Soft tissue friendly; avoids nerve lesions.
(23) Kramer, Mectron The instrument allowed an easy and precise handling.
2006 Piezosurgery No visible damage to soft tissues.
The initiation of the osteotomy did not involve the risk of accidental dislocation of the
osteotome.
In contrast to procedures with conventional reciprocating saws using macrovibrations, no
contrasting actions were required to perform the osteotomies.
The exposure of bone surfaces at the osteotomy sites was less extensive than that required
for conventional osteotomy techniques.
Reduces manual pressure.
(24) Gleizal Mectron Lack of soft tissue injury.
et al., 2007 Piezosurgery Precise cutting.
Maintains a blood-free operative area, permitting great intraoperative visible control with the
consequent increase in safety.
(25) Salami Mectron Preserves soft tissues.
et al., 2009 Piezosurgery Selective cut.
Blood loss was practically absent
The microvibrations that are created in the piezoelectric handpiece allow easy control of the
osteotomy procedure, increasing the tactile control of the instrument and, thus, the cutting
precision.
Good manageability.
The safety of this device is also considerable in terms of low indirect thermal damage to the
bone surfaces and adjacent structures (e.g., facial nerve and vessels) because of the
effective and widespread irrigation with cooled saline solution on the surgical site.
(26) Salami Mectron Precision.
et al., 2010 Piezosurgery Easy intraoperative management and easy control of the device.
Safe and effective.
Safety on soft tissues during unintentional contact.
The absence of skin injuries highlights the fast healing process observed in the
postoperative period.
(27) Salami Mectron Precision and selective cut.
et al., 2010 Piezosurgery Easy intraoperative management and control of the osteotomy procedure.
Safety on soft tissues; during unintentional contact with the facial nerve, lateral sinus, and
dura mater, no patient experienced side effects.
Blood loss was practically absent.
(28) Salami Mectron Rapid and easy intra-operative management; good manageability. The micrometric
et al., 2010 Piezosurgery oscillation allows easy control of the osteotomy procedure, increasing the tactile control of
the instrument and thus the cutting precision
Precise and safe cut.
Bone preservation.
The operating fields were blood-free, with perfect intra-operative visibility.
No damage to soft tissues.
(29) Crippa Mectron Safe and minimally invasive tool. Absence of side effects on the soft tissues.
et al., 2011 Piezosurgery Reduces blood loss.
Allows quick recovery, with a lower postoperative level of pain.
(30) Mectron Control of the piezosurgical device at cutting proved to be excellent, easy and comfortable
Grauvogel et Piezosurgery for the surgeon since bone can carefully be removed layer by layer in a shaping way with
al., 2011 limited pressure and without any potentially dangerous rotating power.
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The stress on the surgeon during the cutting process was considerably reduced.
Prevents soft-tissue damages.
Since the device features an integrated irrigation, the surgical field was always clear, and
the second hand could be used for operating additional instruments.
Safe, precise and convenient.
(31) Mectron Reduces damage to surrounding soft tissues.
Heredero et Piezosurgery Minimally invasive.
al., 2011
(32) Mancini Mectron Precise and selected cutting on bone and cartilage.
et al., 2012 Piezosurgery Does not damage the mucous membranes, so it should result in less scar contractures and
in the absence of synechiae (especially among middle turbinate and septum).
Rapid healing time.
(33) Mectron Safe, precise, and selective bone cut.
Grauvogel et Piezosurgery Avoids soft tissues injury.
al., 2014

In conclusion, according to the present clinical evaluation, the requirement of acceptable


benefit/risk profile of the Oscar device can be considered satisfied.

Analysis of complaints:

Orthofix complaints from the market are managed by Orthofix Quality Assurance & Regulatory
Dept, using the specific computerised software Qbase since 2001 July. This system allows to
constantly monitor the trend of problems reported with Orthofix devices and to trace returned
products by product code, lot number, manufacturing date, cause, etc. Orthofix conducts an
investigation on all devices returned from the market and provides customers with its failure
analysis results.

From 2017 to date 126 complaints involving Oscar have been analysed and closed. The complaints
have been summarized as follows:
REPORTED TO CA

ADVERSE
CAUSE ANALYSIS
EFFECTS

Incorrect handling NO N
Production problem NO N
Device performed properly NO N
Normal wear and tear NO N
Incorrect use NO N

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Normal wear and tear NO N
Incorrect use NO N
Normal wear and tear NO N
Normal wear and tear NO N
Excessive torque NO N
Normal wear and tear NO N
Not
Device performed properly N
Applicable
Not
Device performed properly N
Applicable
Not
Incorrect handling N
Applicable
Not
Normal wear and tear N
Applicable
Not
Normal wear and tear N
Applicable
Not
Normal wear and tear N
Applicable
Not
Excessive torque N
Applicable
Not
Incorrect handling N
Applicable
Not
Device performed properly N
Applicable
Not
Excessive torque N
Applicable
Errata apertura No N
Not
Incorrect handling N
Applicable
Not
Normal wear and tear N
Applicable
Normal wear and tear No N
Normal wear and tear No N
Incorrect handling No N
Incorrect handling NO N
Excessive torque NO N
Normal wear and tear N/A N
Normal wear and tear N/A N
Normal wear and tear N/A N
Normal wear and tear N/A N
Normal wear and tear NO N
Incorrect handling NO N

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Incorrect handling NO (delay) N
Normal wear and tear NO N
Device performed properly NO N
Device performed properly NO N
Normal wear and tear NO N
Excessive torque NO N
Normal wear and tear NO N
Normal wear and tear NO N
Normal wear and tear NO N
Normal wear and tear NO N
Cyclic load - feature related NO Y
Normal wear and tear NO N
Not
Device performed properly N
applicable
Not
Device performed properly N
applicable
Normal wear and tear NO N
Normal wear and tear NO N
Not
Normal wear and tear N
applicable
Not
Normal wear and tear N
applicable
Not
Normal wear and tear N
applicable
Incorrect handling YES Y
Device performed properly YES Y
Device performed properly YES Y
Incorrect handling NO N
Normal wear and tear NO N
Incorrect handling NO N
Normal wear and tear NO N
Cyclic load - feature related NO Y
Normal wear and tear NO N
Normal wear and tear NO N
Normal wear and tear NO N
Normal wear and tear NO N
Device performed properly NO N
Device performed properly NO N
Normal wear and tear NO N

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Not
Normal wear and tear N
applicable
Device performed properly NO N
Device performed properly NO N
Device performed properly NO N
Device performed properly NO N
Normal wear and tear NO N
Not
Device performed properly N
applicable
Not
Normal wear and tear N
applicable
Not
Normal wear and tear N
applicable
Not
Incorrect use N
applicable
Unknown NO N
Not
Device performed properly N
applicable
Not
Incorrect handling N
applicable
Normal wear and tear NO N
Not
Incorrect handling N
applicable
Normal wear and tear NO N
Normal wear and tear NO N
Unknown Unknown Y
YES-only
Cyclic load - feature related Y
extra time
YES-only
Cyclic load - feature related Y
extra time
Not
Normal wear and tear N
applicable
Not
Normal wear and tear N
applicable
Not
Production problem N
applicable
Not
Normal wear and tear N
applicable
Not
Normal wear and tear N
applicable
Not
Normal wear and tear N
applicable
Not
Normal wear and tear N
applicable

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Not
Normal wear and tear N
applicable
Normal wear and tear NO Y
Cyclic load - feature related NO Y
Unknown NO Y
Unknown NO N
Not
Incorrect handling N
applicable
Not
Incorrect handling N
applicable
Not
Normal wear and tear N
applicable
Normal wear and tear Unknown N
Normal wear and tear Unknown N
Not
Device performed properly N
applicable
Not
Normal wear and tear N
applicable
Not
Normal wear and tear N
applicable
Not
Normal wear and tear N
applicable
Normal wear and tear Unknown N
Normal wear and tear Unknown N
YES-only
Normal wear and tear Y
extra time
YES-only
Normal wear and tear Y
extra time
YES-only
Normal wear and tear Y
extra time
YES-only
Normal wear and tear Y
extra time
YES-only
Normal wear and tear Y
extra time
Device performed properly Unknown N
Normal wear and tear Unknown N
Normal wear and tear Unknown N
Not
Normal wear and tear N
applicable
YES-only
Device performed properly Y
extra time
YES-only
Normal wear and tear Y
extra time

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YES-only
Normal wear and tear Y
extra time
Not
Normal wear and tear N
applicable
Excessive torque NO N

1 CAPA was opened due to breakage of probes due to marking.


In regard to the complaints on the electronic parts (on the handset, in particular), an analysis of
improvements has been done and it will be considered during the development of the Oscar 4.

Summary of conformity assessment with requirement on performance (MDD ER3 /


AIMDD ER2).

Oscar and equivalent devices were effective for bone cement removal in different revision
surgeries, and specifically revisions of hip (1,2,8,9,13), elbow (4,11), and shoulder (12)
arthroplasty. The authors observe a series of advantages related to the use of Oscar or equivalent
devices in removing bone cement. The piezoelectric action prevents the vibrating tip to damage
soft tissues because of the high frequency used. This feature was exploited by Smith et al. (1) to
access bone cement through the original first hip arthroplasty access even in a delicate situation
where damage to major structures, as cement was protruding into the pelvis, could have occurred
and a retroperitoneal access would have been the alternative option. Further, effective cement
removal using the Oscar device allowed Fletcher et al. (2) to shorten the length of osteotomy in
the transfemoral approach to remove the femoral stem during hip arthroplasty, sparing a
significant amount of bone stock and allowing them, in >50% of cases, to implant a shorter
prosthesis than in the traditional approach. Comments in the NICE reports by NICE experts are
consistent with these observations: all agree that using Oscar/an equivalent device may reduce the
need of performing large osteotomies, and the risk of cortical perforation. The claim of a low risk
of cortical perforation is supported by the cadaver study of Brooks et al. (6) who showed that even
when a 1-mm thick cortical layer is involved, the loads to apply to observe fracture are significantly
greater than those normally used to remove cement.

Concerning bone cutting, literature retrieved shows that an ultrasonic scalpel like Oscar can
be used effectively in a number of applications involving osteotomies that are not limited to
Orthopaedics (the intended field of application of Oscar) but extend to other fields, such as
Neurosurgery, ENT and Foot&Hand surgery. Devices equivalent to Oscar are routinely applied
effectively to perform spinal decompression for extradural pathologies (Bydon et al., 2013 (14);
Bydon et al., 2014 (19); Pakzaban, 2014 (20)) ore vertebral osteoplasty during discectomy
(Grauvogel et al., 2014 (33)); in spine surgery (Hu X et al., 2013(15); Nickele C et al., 2013 (16);
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Parker SL et al., 2013 (17), Al-Mahfoudh et al., 2014 (18), Al-Mahfoudh et al., 2016 (21)); in hand
surgery (Hoigne et al., 2006 (22)); in craniofacial surgery, even involving pediatric populations
(Kramer FJ et al., 2006 (23); Gleizal A et al., 2007 (24); Heredero Jung et al., 2011 (31)); in otologic
or ENT surgery (Salami A et al., 2009 (25), 2010 (26,27); 2011 (28); Crippa et al., 2011 (29);
Grauvogel et al., 2011 (30), Mancini G et al., 2012 (32)). In all these applications, the ultrasonic
bone cutters equivalent to Oscar were effective. Indeed, surgeons highlight some advantages of
ultrasonic bone cutting, such as precision in cutting, limited vibrations, minimal bone loss, the
utility of a wide range of tips to perform different type of cuts or access to different bone parts, a
blood-free operative area because of the cavitation effect induced by the ultrasonic vibration on
the irrigation solution. In all cases, and especially in spinal and ear surgeries, the fact that the
ultrasonic bone cutters equivalent to Oscar greatly reduce the risk of damage to soft tissues was
perceived as conveying a sense of safer operating conditions to the surgeon. In some cases, the
use of devices equivalent to Oscar actually allowed to spare delicate structures from
removal/cutting as described in Mancini G et al., 2012 (32), where the author managed to spare
the sinus mucosa using an ultrasonic bone cutter to perform transnasal endoscopic osteotomy and
osteoplasty.

Thus, the performance of the Oscar device, or of an equivalent medical device, was satisfactory for
both bone cement removal and bone cutting.

Summary of conformity assessment with requirement on acceptability of undesirable


side-effects (MDD ER6 / AIMDD ER5).

As highlighted in the previous paragraph concerning the Summary of clinical data and Summary of
conformity assessment with requirement on safety, data is of sufficient amount and quality to
allow detecting the undesirable effects connected with the use of the device. The rate of adverse
events associated with the use of the device was extremely low; those related directly to the
application of the device in the orthopedic field thermal injury (3) and bone perforation caused by
misuse of the device (wrong assembly) (9).

To our opinion, no gaps or unanswered questions remain concerning the side effects and their
acceptability. Side effects, as already outlined, may be regarded as definitively acceptable at the
light of the benefits deriving from the use of the piezoelectric instruments.

Summary about data supporting the essential requirements and the performance
claims
Overall, the clinical data retrieved showed that the use of the Oscar device, or of an equivalent
device, was safe and effective and all the relevant MDD ERs are supported by the clinical data
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retrieved. An exception should be made for references 3 and 9, in which, as largely discussed in the
previous sections, complications related to the use of the device were observed (3,9). The hazards
deriving from thermal damage and wrong assembly of the device, as reported in those references,
can be avoided by proper irrigation and adequate surgical knowledge.

As outlined in the Summary of conformity assessment with requirement on acceptable


benefit/risk profile, all the performance claims of the manufacturer -as listed in Section 5- are
supported by the assessed data.

Claim Reference
Efficient Piezoelectric devices allow to reduce the need to use manual
performance: instruments, allowing for a controlled surgical experience and increased
designed to reduce precision (20;23;25;30) (see Table in Section 10, Summary of conformity
manual force assessment with requirement on acceptable benefit/risk profile (MDD
ER1 / AIMDD ER1).
The performance is In all articles retrieved, the device achieved the expected performance,
reproducible allowing the surgeons to make precise cut or remove bone cement.
The equipment is The authors of several articles (1; 8;22;25;26;27;28;30) directly support
simple to operate. that the equipment was simple to operate and handle. (see Table in
Section 10, Summary of conformity assessment with requirement on
acceptable benefit/risk profile (MDD ER1 / AIMDD ER1).
Versatile: single use The device is versatile by virtue of its design thought to make Oscar
probes for both practical for both the bone cutting and bone cement removal
cement and applications. Several single use probes with different sizes and shapes are
prosthesis removal. available; Oscar was in fact used in different anatomic regions, including
pelvis, hip, humerus, and elbow.
A specific comment on the probe design was made by Hoigne et al. (22):
“The tip of the instrument is exchangeable. Using the fine tip enables
multiplanar as well as curved cutting”.
A concern regarding the design of the handpiece was raised by Grauvogel
et al. (30) who reported that a longer and thinner
handpiece or a bayonet-shaped design of the handpiece
would considerably facilitate the procedure. The limits of the design were
however strictly linked to the type of surgery performed, i.e., neuroma
surgery, and the need to handle the device in the narrow space of the
human cerebellopontine angle. The author stated that this becomes a
minor problem with increasing expertise. No concerns were raised in the
articles dealing with the orthopedic field.
Safe: designed to The use of the piezoelectric device minimizes the risk of damage to bone
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minimize accidental by avoiding perforation or fracture. This is indirectly supported by the
bone damage fact that the device was overall safe and directly supported by the
authors’ comments in references 1;2;5;6;8;12;16;25;28;30 (see Table in
Section 10, Summary of conformity assessment with requirement on
acceptable benefit/risk profile (MDD ER1 / AIMDD ER1).

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11. EXPLANATION OF THE CLINICAL ASPECTS ADDRESSED IN THE CLINICAL PART OF


THE RISK ANALYSIS

The risks associated to each hazard were carefully estimated and their acceptability was
demonstrated by compliance with available information. No other hazards were generated by the
risk reduction procedure. The remaining risks associated with the identified hazards are
acceptable, having regard to the intended application and use of the device, the risk/benefit ratio
and Orthofix’s Policy for Determining Acceptable Risk (PG208-01) (Ref. Sect. III.b DMF C.1.1-C Risk
Analysis).

12. CONCLUSIONS
On the basis of the clinical data retrieved in literature and on their analysis, the benefits to health
deriving from the use of the Oscar device, as intended by the manufacturer, outweigh the risks of
injury deriving from such use. As it was shown in the paragraphs that precedes, the benefits to
health deriving from the use of the device consist, summarizing, in precise bone cutting/bone
cement removal which is safe for bone as well as soft tissues. The complication rate is extremely
low, yet the device should be used in surgical procedures that must be performed by skilled
surgeons in order to prevent the risk of thermal damage or other injuries caused by misuse of the
device. Provided these conditions are met, as appropriately highlighted in the informative material
that Orthofix provides to the users, the benefit/risk profile of the Oscar device is fully acceptable.

On the basis of the data retrieved, the objectives of the literature review have been met; the risks
identified in the risk analysis document relating to safety and performance have been addressed
by clinical data.

It can be concluded

• that the clinical evaluation demonstrates that any risks which may be associated with the
intended purpose are minimised and acceptable when weighed against the benefits to the patient
and are compatible with a high level of protection of health and safety; and
• that the IFU correctly describe the intended purpose of the device as supported by sufficient
clinical evidence; and
• that the IFU contain correct information to reduce the risk of use error, information on

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residual risks and their management as supported by sufficient clinical evidence (e.g. handling
instructions, description of risks, warnings, precautions, contraindications, instructions for
managing foreseeable unwanted situations).
• that claims as foreseen by the manufacturer are adequate.

When used under the conditions and the purposes intended by the manufacturer the device is in
compliance with:

- Requirement on safety (MDD ER1)


- Requirement on acceptable benefit/risk profile (MDD ER1)
- Requirement on performance (MDD ER3)
- Requirement on acceptability of side-effects (MDD ER6)

During the risks analysis sessions, the following clinical aspects have been identified as topic of future
evaluations:

• ID 2.3.2: possible fatigue failure of the probe


• ID 3.1.1: possible cross-infection of the patient
• ID 4.1.1: possible interference with other devices causing radiation from modules
• ID 4.2.1: possible radiated electromagnetic power capable of interfering with other devices
• ID 5.1.1: possible electric shock to user
• ID 6.3.4: possible burn hazard if flammable liquids in vicinity
• ID 6.3.5: possible erroneous/accidental activation of the device
• ID 6.3.6: possible probe failure with probe fragment inside the horn
• ID 8.10.4: possible component failure for “natural” reasons

Justification of risk reduced A.F.A.P.:


• ID 2.3.2: Probes are designed and tested for transmission of ultrasonic vibrations.
Furthermore, the geometric constraints given by anatomical spaces where they work,
define probes’ geometry. Such geometry can have small sections that are mechanically less
resistant to excessive loads that may occur during surgery. However, the team deems that
the design presents an acceptable ratio between risk of breakage and benefits of
ultrasound technology.
• ID 3.1.1: Similar to all other safe devices on the market (broadly used cleaning, packaging
and sterilization technologies and verification method)

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• ID 4.1.1 and 4.2.1: The occurrence and severity cannot be reasonably reduced any further.
Once EMC is verified, the residual risk is acceptable when weighed against the potential
benefit of ultrasonic tools instead of manual tools.
• ID 5.1.1: The occurrence and severity cannot be reasonably reduced any further. The
residual risk is acceptable when weighed against the potential benefit of ultrasonic tools
instead of manual tools.
• ID 6.3.4: Contact with prosthesis unavoidable in some procedures, which does not cause
any issue providing NO flammable. Therefore, the residual risk is acceptable when weighed
against the potential benefit of ultrasonic tools instead of manual tools.
• ID 6.3.5: Equipment simple to use with activation switch easily detectable. Led available on
generator that permit to understand when the system is active. Furthermore the activation
of system is easily detectable due to vibration and sound produced. Therefore, the residual
risk is acceptable when weighed against the potential benefit of ultrasonic tools instead of
manual tools.
• ID 6.3.6: Probes are fitted into the horn with an M6 threaded portion. Such dimensioning
of threaded connection is widely used in orthopaedics. Included Orthofix product. The
necessary locking torque is proven much lower than failure torque
• ID 8.10.4: In a complex electric system the failure of components for “natural” reasons
cannot be easily prevented. The system is therefore equipped with a logic that interrupts
hazardous outputs when in failure mode. The remaining hazard becomes then the
alternative of manual surgery instead of Oscar assisted surgery. The team deems that this
presents an acceptable balance between the risk of interruption and the benefit of using
ultrasonic technology.

Detailed information is reported in Oscar3 RMF_rev.2.4.


Nevertheless, specific post-market activities will be planned to collect information on the safety and
performance of the Oscar 3.
Detailed information on the Post Market Surveillance activities planned for the G-Beam is reported in
the next paragraph and in ANNEX E.

13. POST MARKET SURVEILLANCE ACTIVITIES AND DATE OF THE NEXT CLINICAL
EVALUATION

Orthofix Srl, the manufacturer of the device, is responsible worldwide for the post market
surveillance.
Orthofix Srl has established documented procedures, which describe the requirements, criteria,
activities and relevant responsibilities for the management of post market surveillance activities,
including product complaints and medical device reporting activities (Annex E).
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The complaints from the market are managed by Orthofix Srl, who constantly monitors the trend
of problems reported with Orthofix devices and conducts an investigation on all devices returned
from the market to provide customers with failure analysis results.

Date of the next clinical evaluation: May 2020

14. REFERENCES
1 Smith, PN; Eyres, KS. Safe removal of massive intrapelvic cement using ultrasonic
instruments. J Arthroplasty. 1999;14(2):235-8.
2 Fletcher, M; Jennings, GJ; Warren, PJ. Ultrasonically driven instruments in the transfemoral
approach--an aid to preservation of bone stock and reduction of implant length. Arch
Orthop Trauma Surg. 2000;120(10):559-61.
3 Goldberg, SH; Cohen, MS; Young, M; Bradnock, B. Thermal tissue damage caused by
ultrasonic cement removal from the humerus. J Bone Joint Surg Am. 2005;87(3):583-91.
4 Peach, CA; Nicoletti, S; Lawrence, TM; Stanley, D. Two-stage revision for the treatment of
the infected total elbow arthroplasty. Bone Joint J. 2013;95-B(12):1681-6.
5 NICE - The National Institute for Health and Care Excellence. The OSCAR 3 ultrasonic
arthroplasty revision instrument for removing bone cement during prosthetic joint
revision. Published: 19 November 2014
6 Brooks, AT; Nelson, CL; Hofmann, OE. Minimal femoral cortical thickness necessary to
prevent perforation by ultrasonic tools in joint revision surgery. J Arthroplasty.
1995;10(3):359-62.
7 Brooks, AT; Nelson, CL; Stewart, CL; Skinner, RA; Siems, ML. Effect of an ultrasonic device
on temperatures generated in bone and on bone-cement structure. J Arthroplasty.
1993;8(4):413-8.
8 Klapper, RC; Caillouette, JT; Callaghan, JJ; Hozack, WJ. Ultrasonic technology in revision
joint arthroplasty. Clin Orthop Relat Res. 1992;(285):147-54.
9 de Steiger, RN; Pandey, R; McLardy-Smith, P. Ultrasonically driven tools. J Arthroplasty.
1996;11(1):120-1.
10 Haddad, FS; Muirhead-Allwood, SK; Manktelow, AR; Bacarese-Hamilton, I. Two-stage
uncemented revision hip arthroplasty for infection. J Bone Joint Surg Br.
2000;82(5):689-94.
11 Sneftrup, SB; Jensen, SL; Johannsen, HV; Søjbjerg, JO. Revision of failed total elbow
arthroplasty with use of a linked implant. J Bone Joint Surg Br. 2006;88(1):78-83.
12 Van Thiel, GS; Halloran, JP; Twigg, S; Romeo, AA; Nicholson, GP. The vertical humeral
osteotomy for stem removal in revision shoulder arthroplasty: results and technique. J
Shoulder Elbow Surg. 2011;20(8):1248-54.
13 van Diemen, MP; Colen, S; Dalemans, AA; Stuyck, J; Mulier, M. Two-stage revision of an
infected total hip arthroplasty: a follow-up of 136 patients. Hip Int. 2013;23(5):445-50.
Orthofix Srl - Via delle Nazioni, 9 37012- Bussolengo (VR)
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14 Bydon, M; Macki, M; Xu, R; Ain, MC; Ahn, ES; Jallo, GI. Spinal decompression in
achondroplastic patients using high-speed drill versus ultrasonic bone curette: technical
note and outcomes in 30 cases. J Pediatr Orthop. 2014;34(8):780-6.
15 Hu, X; Ohnmeiss, DD; Lieberman, IH. Use of an ultrasonic osteotome device in spine
surgery: experience from the first 128 patients. Eur Spine J. 2013;22(12):2845-9.
16 Nickele, C; Hanna, A; Baskaya, MK. Osteotomy for laminoplasty without soft tissue
penetration, performed using a harmonic bone scalpel: instrumentation and technique.
J Neurol Surg A Cent Eur Neurosurg. 2013;74(3):183-6.
17 Parker, SL; Kretzer, RM; Recinos, PF; Molina, CA; Wolinsky, JP; Jallo, GI; Recinos, VR.
Ultrasonic BoneScalpel for osteoplastic laminoplasty in the resection of intradural
spinal pathology: case series and technical note. Neurosurgery. 2013;73(1 Suppl
Operative):ons61-6.
18 Al-Mahfoudh, R; Qattan, E; Ellenbogen, JR; Wilby, M; Barrett, C; Pigott, T. Applications of
the ultrasonic bone cutter in spinal surgery--our preliminary experience. Br J Neurosurg.
2014;28(1):56-60.
19 Bydon, M; Xu, R; Papademetriou, K; Sciubba, DM; Wolinsky, JP; Witham, TF; Gokaslan, ZL;
Jallo, G; Bydon, A. Safety of spinal decompression using an ultrasonic bone curette
compared with a high-speed drill: outcomes in 337 patients. J Neurosurg Spine.
2013;18(6):627-33.
20 Pakzaban, P. Ultrasonic total uncinectomy: a novel technique for complete anterior
decompression of cervical nerve roots. Neurosurgery. 2014;10 Suppl 4():535-41;
discussion 541.
21 Al-Mahfoudh, R; Mitchell, PS; Wilby, M; Crooks, D; Barrett, C; Pillay, R; Pigott, T.
Management of Giant Calcified Thoracic Disks and Description of the Trench
Vertebrectomy Technique. Global Spine J. 2016;6(6):584-91.
22 Hoigne, DJ; Stübinger, S; Von Kaenel, O; Shamdasani, S; Hasenboehler, P. Piezoelectric
osteotomy in hand surgery: first experiences with a new technique. BMC Musculoskelet
Disord. 2006;7():36.
23 Kramer, FJ; Ludwig, HC; Materna, T; Gruber, R; Merten, HA; Schliephake, H. Piezoelectric
osteotomies in craniofacial procedures: a series of 15 pediatric patients. Technical note.
J Neurosurg. 2006;104(1 Suppl):68-71.
24 Gleizal, A; Bera, JC; Lavandier, B; Beziat, JL. Piezoelectric osteotomy: a new technique for
bone surgery-advantages in craniofacial surgery. Childs Nerv Syst. 2007;23(5):509-13.
25 Salami, A; Dellepiane, M; Proto, E; Mora, R. Piezosurgery in otologic surgery: four years of
experience. Otolaryngol Head Neck Surg. 2009;140(3):412-8.
26 Salami, A; Mora, R; Dellepiane, M; Guastini, L. Piezosurgery for removal of symptomatic ear
osteoma. Eur Arch Otorhinolaryngol. 2010;267(10):1527-30.
27 Salami, A; Mora, R; Dellepiane, M; Crippa, B; Guastini, L. Results of revision mastoidectomy
with Piezosurgery(®). Acta Otolaryngol. 2010;130(10):1119-24.

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Clinical Evaluation Report


Oscar – Ultrasonic Arthroplasty Revision 3
28 Salami, A; Mora, R; Dellepiane, M; Crippa, B; Santomauro, V; Guastini, L. Piezosurgery
versus microdrill in intact canal wall mastoidectomy. Eur Arch Otorhinolaryngol.
2010;267(11):1705-11.
29 Crippa, B; Salzano, FA; Mora, R; Dellepiane, M; Salami, A; Guastini, L. Comparison of
postoperative pain: piezoelectric device versus microdrill. Eur Arch Otorhinolaryngol.
2011;268(9):1279-82.
30 Grauvogel, J; Scheiwe, C; Kaminsky, J. Use of piezosurgery for internal auditory canal
drilling in acoustic neuroma surgery. Acta Neurochir (Wien). 2011;153(10):1941-7;
discussion 1947.
31 Heredero Jung, S; Dean Ferrer, A; Solivera Vela, J; Alamillos Granados, F. Spheno-orbital
meningioma resection and reconstruction: the role of piezosurgery and premolded
titanium mesh. Craniomaxillofac Trauma Reconstr. 2011;4(4):193-200.
32 Mancini, G; Buonaccorsi, S; Reale, G; Tedaldi, M. Application of piezoelectric device in
endoscopic sinus surgery. J Craniofac Surg. 2012;23(6):1736-40.
33 Grauvogel, J; Scheiwe, C; Kaminsky, J. Use of Piezosurgery for removal of retrovertebral
body osteophytes in anterior cervical discectomy. Spine J. 2014;14(4):628-36.

15. OTHER DOCUMENTS CONTAINING CLINICAL DATA

Preliminary literature searches and analysis have not been performed.

16. ANNEXES

ANNEX A: Clinical Evaluation Plan


ANNEX B: Literature Search Report
ANNEX C: CV of medical evaluator and explanation for suitability of the author
ANNEX D: Declaration of interests
ANNEX E: Post market surveillance plan
ANNEX F: List of publications
ANNEX G: Preliminary literature searches not included in the Clinical Evaluation Report
ANNEX H: References to labelling, IFU, available promotional materials including accompanying
documents possibly foreseen by the manufacturer

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