Injury, Int. J.

Care Injured (2004) 35, 567—574

Fluoroscopic guidance versus surgical navigation

for distal locking of intramedullary implants
A prospective, controlled clinical study
Norbert Suhma,*, Peter Messmera, Ivan Zunab, Ludwig A. Jacobc,
Pietro Regazzonia

a
Department of Surgery, University Hospital Basel, Spitalstrasse 21, CH-4031 Basel, Switzerland
b
German Cancer Research Centre, INF 280, D-69120 Heidelberg, Germany
c
Department of Radiology, University Hospital Basel, Spitalstrasse 21, CH-4031 Basel, Switzerland
Accepted 28 April 2003

KEYWORDS
Fluoroscopy-based
surgical navigation;
Virtual fluoroscopy;
Distal locking;
Intramedullary nailing;
Exposure to radiation
Summary A prospective controlled clinical study was performed to compare fluoro-
scopic guidance with fluoroscopy-based surgical navigation for distal locking of intra-
medullary implants. Forty-two patients with fractures of the lower extremity treated
by intramedullary nailing were divided in two groups: distal locking either with
fluoroscopic guidance (group I) or with surgical navigation (group II). The average
fluoroscopic time to insert one interlocking screw with fluoroscopic guidance was 108 s
compared with 7.3 s in the navigation group. The average procedure time to insert one
interlocking screw in group I was 13.7 min compared with 17.9 min in group II. The drill
bit failed to pass through the interlocking hole in one patient from group II. There
was no significant difference in the technical reliability between both groups. Fluoro-
scopic times to achieve equivalent precision are reduced with fluoroscopy-based
surgical navigation compared with fluoroscopic guidance. Fluoroscopy-based surgical
navigation is recommended for intraoperative guidance in situations where reduction
of exposure to radiation is considered advantageous over the increase of procedure
time.
ß 2003 Elsevier Ltd. All rights reserved.

Introduction because the long-term effects of exposure to

The number and variety of orthopaedic surgical
procedures utilizing fluoroscopic guidance have
increased. The radiation risks to surgical personnel
and measures that can be taken to prevent excessive
exposures have been explored.12 Radiation exposure
should be kept as low as reasonably achievable
*Corresponding author. Tel.: þ41-81-414-2465;
fax: þ41-81-414-2285.
E-mail address: nsuhm@web.de (N. Suhm).
0020–1383/$ — see front matter ß 2003 Elsevier Ltd. All rights reserved.
doi:10.1016/S0020-1383(03)00312-7
low-level radiation are still largely unknown.7 The
occupational exposure to radiation resulting from
fluoroscopic guidance strongly depends on the fluoro-
scopic time.4,8 Minutes of live fluoroscopy are
required during stabilisation of long bone fractures
with intramedullary nailing in order to determine the
appropriate location of the starting hole and align-
ment for the distal locking screws.1,5,10
Fluoroscopy-based surgical navigation offers
continuous intraoperative guidance based on stored
fluoroscopic images. This could potentially reduce
568
the fluoroscopic times required for intraoperative
guidance. In an effort to reduce radiation dose
during fluoroscopic guidance, surgical navigation
has been proposed as an alternative method for
surgical guidance in general,2 and more specifically
for distal locking of intramedullary nails.11
The purpose of this controlled prospective
clinical study was to compare the fluoroscopic
time and resources required for distal locking with
either fluoroscopic guidance or with fluoroscopy-
based surgical navigation. The precision achieved
and the reliability of both methods were also mea-
sured.
Materials and methods
Study design and patients
The study design was approved by the ethics com-
mittee at the authors’ institution. The study com-
prised of 42 patients with 44 fractures of the lower
extremity. All patients gave informed consent
to participate in the study. Forty-two fractures
were the result of trauma. One patient with a
pathological fracture and one patient with revision
nailing osteosynthesis for implant failure were also
included. Fractures were classified according to the
guidelines of the Association for the Study of Inter-
nal Fixation (ASIF). The inclusion criteria were a
type 31 A3 pertrochanteric femoral fracture with
subtrochanteric extension, a type 32 A, B, C femoral
fracture, or a type 42 A, B, C tibia fracture suitable
for closed fracture reduction and nailing osteo-
synthesis. The exclusion criteria included a bone
or soft tissue infection at the fracture site and an
open fracture. No patients were excluded from the
study for these reasons.
The patients were assigned to one of two treat-
ment groups depending on their anaesthetic risk
assessed according to the American Society of
Anaesthesiology from grades I—V. The guidance
method used for distal locking was different in both
groups. Patients in group I had distal locking with
fluoroscopic guidance. In group II distal locking
was performed with fluoroscopy-based surgical
navigation. Prior experience from the author’s
laboratory test series showed that fluoroscopy-
based surgical navigation for distal locking length-
ens procedure times. Only patients with low anaes-
thetic risks (grades I and II) were included in
group II. Patients with higher risks (grades III—V)
were included in group I (group I: the expected
shorter procedure time). The risk score was deter-
mined by the anaesthetist during the preoperative
visit.
N. Suhm et al.
Surgical technique
Depending on the preoperative fracture classifica-
tion three different types of intramedullary nails
were used for osteosynthesis: the long proximal
femoral nail PFNÕ, the unreamed femoral nail
UFNÕ and the unreamed tibia nail UTNÕ (all
implants: Synthes, Paoli, PA). Fracture reduction
and implant insertion were performed with the
patient under general or regional anaesthesia in a
standard fashion according to the implant specific
guidelines given by the manufacturer.
Fluoroscopic guidance is used routinely for distal
interlocking of the intramedullary nails used in the
study and the technique is well known.
Fluoroscopy-based surgical navigation describes
a technique for surgical navigation that is based on
intraoperative fluoroscopic images.2 Surgical navi-
gation allows real time interactive targeting on the
basis of stored image data.
A system for fluoroscopy-based surgical naviga-
tion consists of computation equipment, a c-arm
fluoroscope adapted for use with a surgical naviga-
tion system, and equipment for optoelectronic posi-
tion detection called tracking. The authors used the
SurgiGATEÕ system (Medivision, Oberdorf, Switzer-
land) for intraoperative guidance. All computation
processes run on a SUN ULTRA 1 workstation (Sun
Microsystems Inc., CA). A standard Philips BV 29
c-arm fluoroscope (Philips Medical Systems, Best,
The Netherlands) was prepared for use with the
navigation system by attaching a reference shield
to the image intensifier component of the c-arm
fluoroscope. Reference shields are equipped with
infrared light emitting diodes. The SurgiGATEÕ sys-
tem employs an infrared camera (Optotrack 3020,
Northern Digital, Waterloo, Ont., Canada) to track
the position of these light emitting diodes. In the set
up for distal locking, the compact air drive, the
c-arm fluoroscope and the nail insertion handle are
equipped with position reference units to enable
position definition by the system’s tracking unit.2,11
Distal locking with fluoroscopy-based surgical
navigation was performed in two steps. Step 1:
image acquisition. The image data are acquired
after nail insertion into the medullary canal and
therefore after possible nail deformation. Exact
alignment of the fluoroscope before image acquisi-
tion is an essential prerequisite for successful distal
locking. The nail’s locking holes must be imaged as
perfect circles. The positions of the referenced
c-arm fluoroscope and referenced insertion handle
are tracked (Fig. 1). Step 2: drilling the interlocking
holes with continuous guidance by fluoroscopy-
based surgical navigation. The positions of the
referenced compact air drive and the referenced
Fluoroscopic guidance versus surgical navigation 569

Figure 1 Image acquisition with fluoroscopy-based surgical navigation for distal locking in revision surgery: patient’s
feet left margin, patient’s head right margin, patient in supine position. A Grosse Kempf femoral nail had to be
removed from the left femur for implant failure, spongious bone grafting was performed and a long PFNÕ nail inserted
into the medullary canal (see large incision). The fluoroscope is aligned in the lateral projection for image acquisition.
The fluoroscope’s reference base (A, arrow) and the nail reference base (B, arrow) must be in line of sight with the
infrared tracking unit (not visible).

nail insertion handle are tracked. A graphic display
of the drill bit then is overlaid on the stored image of
the distal locking holes in real time. The drill is then
introduced through an incision until it contacts
bone. The drill bit is moved along the surface of
the bone until its projection on the computer screen
is located exactly in the centre of the distal locking
hole. After the drill’s axis has been aligned with the
axis of the interlocking hole the drill is driven into
the bone and through the interlocking hole in the
nail into the opposite cortex (Fig. 2). Precision in
passing the drill through the interlocking holes is
evaluated as described below. The interlocking
screw’s correct position is confirmed with intrao-
perative check fluoroscopy.
Documentation
The data evaluated intraoperatively included
fluoroscopic time and procedure time, precision
in passing the drill bit through the interlocking
holes, type and severity of problems with the inter-
locking procedure, and the experience of the sur-
geon with the guidance method.
Documented fluoroscopic and procedure time in
both groups included all steps beginning with c-arm
alignment for image acquisition ending with check
fluoroscopy to verify correct screw position.
The precision of passing the drill through the
interlocking holes in the nail was assessed by the
surgeon as ‘‘successful without contact with the
nail’’, ‘‘successful with slight or severe contact
with the nail’’, or as ‘‘failure in distal locking’’.
The failure rate of a guidance method was cal-
culated as number of failures in distal locking per
number of interlocking screws inserted using the
relevant guidance method.
Intraoperative problems during the interlocking
procedure were classified as related to lack of
precision or as related to the technical equipment
that was used for guidance. The severity of intrao-
perative problems was rated as major or minor by
the surgeon as follows: technical problems were
rated as major when they could not be solved within
10 min during the procedure and were rated as
minor in all other cases.
A major problem related to lack of precision was
defined as intraoperative situation when measures
had to be taken in order to improve guidance of the
drill. This included detection of failures in distal
locking or severe contact to the nail. A minor
problem related to lack of precision did not mean
any change of the procedure. This included slight
contact between the drill bit and the nail.
In patients within group II in whom a major intra-
operative problem was recognized, the scheduled
570 N. Suhm et al.

Figure 2 Continuous intraoperative guidance with fluoroscopy-based surgical navigation: the c-arm fluoroscope is
removed from the patient and the computer screen positioned opposite to the surgeon. The nail’s reference base (B,
arrow) and the compact air drive’s reference base (C, arrow) must be in line of sight for the infrared tracking unit (not
visible). Based on the actual position data, a graphic display of the drill bit is overlaid on the stored fluoroscopic
images.

procedure was stopped. The patients then had Analysis

fluoroscopic guidance. In patients within group I
in whom a major problem was recognized, a salvage
guidance method could not be used and the distal
locking procedure had to be completed with fluoro-
scopic guidance. The data on fluoroscopic times and
procedure times from those patients in whom a
major intraoperative problem had been recognized
were excluded from statistical analysis.
Precision-related problems could occur with
every attempt to pass the drill bit through the
interlocking hole in the nail. The rate of preci-
sion-related intraoperative problems was defined
as the number of precision-related problems
divided by the number of attempts to pass the drill
bit through the interlocking hole with the guidance
method.
Technical problems potentially could occur at
any moment during the interlocking procedure.
The probability rate of technical intraoperative
problems was defined as the number of problems
observed divided by the number of osteosynthesis in
which the relevant guidance method was used.
The surgeons were divided into three groups
dependent on their past experience with the dif-
ferent guidance methods used: junior resident (JR)
with less than 20 applications, senior resident (SR)
with 20—100 applications, and chief (C) with more
than 100 applications of the guidance method.
Power analysis
The authors hypothesized that compared with
fluoroscopic guidance, fluoroscopic times needed
to achieve equivalent accuracy would decrease with
fluoroscopy-based surgical navigation. Power ana-
lysis based on previous reports of fluoroscopic times
for distal locking using fluoroscopic guidance,5
or using fluoroscopy-based surgical navigation11
showed that to detect a difference of 25 s in the
fluoroscopic time between groups, 20 patients were
needed in each group for beta equal to 0.8.
Patient evaluation
All patients were routinely reevaluated 6 and 12
weeks postoperatively. At both follow up, the stab
wounds were inspected.
Statistical analysis
Demographic data were analyzed with Chi-square
test, Fisher’s exact test, and Student’s t-test.
Differences between groups with regard to
fluoroscopic time and procedure time were evalu-
ated with unpaired t-tests. Differences between
groups with regard to precision of distal locking,
technical reliability or experience of the responsi-
ble surgeon were evaluated with Chi-square test
and Fisher’s exact test. Statistical analysis was
Fluoroscopic guidance versus surgical navigation
performed with use of the Statistical Analysis Soft-
ware (SASÕ, version 8.E for Windows; The SAS Insti-
tute, Heidelberg, Germany). All continuous data are
expressed as the mean and the standard deviation.
For all tests, probability less than 0.05 was consid-
ered significant.
Results
Group I: fluoroscopic guidance
Group I contained 20 patients with 21 fractures. In
one multiple injured patient bilateral tibia fractures
were treated with nailing on both sides. The pro-
cedure was rated as two cases in the same patient.
The average age of the 12 men and 8 women was 51
years. For fracture classification and intramedullary
nails used in group I see Table 1. In two patients the
authors used 8 mm unreamed tibial nails requiring
4 mm interlocking screws. All other intramedullary
nails required insertion of 4.9 mm interlocking
screws. In five patients the unreamed tibia nails were
distally interlocked using three screws, two in the
lateral and one in the frontal plane in order to
improve stability. All other intramedullary nails were
interlocked using two screws in the lateral plane.
The average fluoroscopic time (and standard
deviation) to insert one interlocking screw with
fluoroscopic guidance was 108 s (61 s) and the
average procedure time was 13.7 min (4.7 min).
Forty-four interlocking holes passed through by
the drill bit using fluoroscopic guidance were
included for precision evaluation. There were no
failures, but there was one precision-related major
intraoperative problem. There were nine minor
precision-related problems. There was one major
technical-related intraoperative problem in 21
applications; the c-arm fluoroscope did not work
properly during distal locking and had to be
replaced. There was one minor technical-related
intraoperative problem in 21 applications; the radi-
olucent drill did not work properly due to incorrect
insertion of the drill bit.
Table 1 Types of intramedullary nails implanted in groups I and II
Fracture Implanted Geometry and diameter of
classification nail interlocking holes
31 A3 PFNÕ long Circular, 4.9 mm
32 A, B, C UFNÕ Circular, 4.9 mm
42 A, B, C UTNÕ Circular, 4.9 mm (or 4 mm)
Fracture types included in the study (fracture classification according to the ASIF), type of intramedullary nail used
for stabilization, geometry of the interlocking holes in the nail, drill bit required and number of patients included in
groups I and II of the study. PFNÕ: proximal femoral nail; UFNÕ: unreamed femoral nail; UTNÕ: unreamed tibia nail.
571
Table 2 The surgeon’s experience with guidance
methods used in the study
Group I Group II
Guidance Fluoroscopic Surgical
method guidance navigation
Experience JR/SR/C 3/13/5 5/18/0
Experience of the surgeon with the guidance method
used in groups I and II of the study. Experience was
rated junior resident (JR)/senior resident (SR)/chief
(C) as defined in the paper.
The surgeon’s experience with fluoroscopic gui-
dance for distal locking is shown in Table 2. There
were no wound healing problems.
Group II: fluoroscopy-based surgical
navigation
Group II contained 22 patients with 23 fractures.
One multiple injured patient had a femoral fracture
and a tibia fracture, both treated with nailing. The
procedures were performed in separate interven-
tions and were rated as two separate treatments.
The average age of the 17 men and 5 women was 46
years. In four patients the authors used 8 mm
unreamed tibial nails requiring 4 mm interlocking
screws. All other intramedullary nails required
insertion of 4.9 mm interlocking screws. In four
patients the unreamed tibial nails were distally
interlocked using three screws, two in the lateral
and one in the frontal plane in order to improve
stability. All other intramedullary nails were inter-
locked using two screws in the lateral plane.
The average fluoroscopic time (and standard
deviation) to insert one interlocking screw with
fluoroscopy-based surgical navigation was 7.3 s
(6.4 s) and the average procedure time was
17.9 min (6.5 min). An additional 40 min were
required prior to incision and after skin closure as
set up times for the navigation system.
Thirty-nine interlocking screws were included for
precision evaluation. There was one failure and
Drill Number of Number of patients
diameter patients in group I in group II
4.0 7 7
4.0 4 4
4.0 (or 3.2) 8 (2) 8 (4)
572
eight precision-related minor intraoperative pro-
blems out of 39 interlocking screws. There were five
major technical-related intraoperative problems
out of 23 applications; in two patients a problem
concerning the tracking unit of the navigation sys-
tem occurred and fluoroscopy-based surgical navi-
gation for distal locking had to be abandoned.
Fluoroscopic guidance then was used and the track-
ing unit was checked after the procedure. In two
patients fluoroscopy-based surgical navigation had
to be abandoned as stored images could not be
properly distorted from the navigation system. In
one patient the nail’s reference base was not visible
due to unusual fixation.
There were two minor technical-related intrao-
perative problems out of 23 applications; in two
patients the authors observed software problems. A
system reset bypassed the problem.
The surgeon’s experience with fluoroscopy-based
surgical navigation for interlocking hole placement
is shown in Table 2.
There was only one stab wound with evidence of
infection. This patient had reosteosynthesis of his
femoral fracture 4 weeks postoperatively because
of deep wound infection. The wound infection was
located proximal at the entry point of the intrame-
dullary nail and was diagnosed in the early rehabi-
litation hospital phase.
Comparison of groups I and II
An unpaired Chi-square test showed no preoperative
significant differences between groups I and II
with respect to gender (P ¼ 0:39), fractured side
(P ¼ 0:062) or type of anaesthesia (P ¼ 0:57). Fish-
er’s exact test revealed no preoperative significant
differences between groups I and II with respect to
the type of intramedullary nails used (P ¼ 0:96) and
to the diameter of interlocking screws inserted
(P ¼ 0:42). An unpaired t-test revealed no preo-
perative significant differences between groups I
and II with respect to the patient’s age (P ¼ 0:45).
Fluoroscopic time needed per interlocking screw
in group II was significantly less than fluoroscopic
time needed in group I (P < 0:0001). Drilling an
interlocking hole using guidance by fluoroscopy-
based surgical navigation required significantly
longer procedure times (P ¼ 0:031) than passing
the drill bit through an interlocking hole with fluoro-
scopic guidance.
No significant differences in the rate of major
(P ¼ 0:93) and in the rate of minor (P ¼ 0:99)
precision-related intraoperative problems could
be detected. No significant differences in the
rate of major (P ¼ 0:10) or in the rate of minor
(P ¼ 0:61) intraoperative technical problems could
N. Suhm et al.
be detected. The surgeon’s experience with fluoro-
scopic guidance in group I was found on a significantly
higher level than experience with fluoroscopy-based
surgical navigation for distal locking in group II
(P ¼ 0:044).
Discussion
Radiation exposure to the surgical team as well as to
the patient during orthopaedic procedures using
fluoroscopic guidance is a universal concern.12
Several studies have evaluated the radiation expo-
sure to orthopaedic surgeons,1 to the theatre
staff,5,6,8,10 and to the patients.4 While all studies
showed that the radiation exposure was well within
guidelines, the exposure times reported by these
authors were considered to be too optimistic.3
Ionizing radiation has no safe threshold of exposure
below which it ceases to have adverse effects.
Kwong et al.4 stressed the importance of minimising
the radiation dose related to fluoroscopic imaging.
Surgical navigation offers the potential to reduce
fluoroscopic times and thus radiation doses.
In this study, the authors compared two guidance
methods for distal locking of intramedullary
implants. The distal locking procedure was selected
as clinical model to evaluate fluoroscopy-based
surgical navigation for several reasons. The distal
locking procedure is common. Furthermore, Levin
et al.5 reports that 60—307 s of fluoroscopic time
are required to insert the distal interlocking screws
using a free-hand method with fluoroscopic gui-
dance. This means 40—50% of the total fluoroscopic
time for nailing are required for the distal locking
procedure.5,10
In the present study, fluoroscopic times for distal
locking with fluoroscopic guidance in group I were
found in good accordance with those reported in the
literature. With fluoroscopy-based surgical naviga-
tion the authors succeeded in reducing the fluoro-
scopic time required to insert one interlocking
screw to 7.3 s.
Slomczykowski et al.9 reported a fluoroscopy
time per pair of distal locking screws of 1.67 s when
the distal locking procedure was performed with an
equivalent surgical navigation system. Aligning the
c-arm fluoroscope, image acquisition and final doc-
umentation take more than 2 s fluoroscopy time in
our experience.
Even though the reduction of fluoroscopy time
achievable is impressive, the impact of this reduc-
tion in fluoroscopic time on the patient’s radiation
dose might be limited. The locking procedures are
performed in a great distance from the radiosensi-
tive organs, so there is only a small contribution to
Fluoroscopic guidance versus surgical navigation
the patient’s effective radiation dose.4 In contrast,
radiation exposure to the surgeon is potentially
reduced with fluoroscopy-based surgical navigation,
as the new technique allows the surgeon to stay far
from the fluoroscope during image acquisition.
Using a free-hand aiming technique with fluoro-
scopic guidance for distal locking, the surgeon is
forced to work within or close to the primary X-ray
beam.5,7
Fluoroscopy-based surgical navigation increased
the need for resources. An additional 40 min were
required prior to skin incision and after skin closure
as set up time for the navigation system. As these
tasks were fulfilled by a trained technician in par-
allel with other duties the patient turnover was
not delayed. While the new method prolonged pro-
cedure times initially, this drawback disappeared
towards the end of our study, as the surgeon
became more familiar with the new technical
equipment. Procedure times of computer assisted
interventions might also decline when dedicated
operation suites become available that are adapted
to the specific needs of image guided surgery.
Technical reliability was better with the standard
guidance method compared with fluoroscopy-
based surgical navigation. The technical problems
observed were partly related to a lack of experience
with the complex equipment. Proper instruction
and testing in the laboratory is strongly advised
prior to application of surgical navigation tech-
nology in clinical practice.
The authors encountered one case of postopera-
tive wound infection among 42 patients, which is
clearly within the limits. The patient was assigned
to group II. This result by no means can be inter-
preted as increased infection rate in interven-
tions performed with fluoroscopy-based surgical
navigation.
The failure rate in actually doing the interlocking
in the clinical setting was found higher than
expected, as the potential accuracy of the system
used by the authors is much greater than this.
However, the navigation system used allowed track-
ing the compact air drive instead of a drill guide.
Bending the drill bit while drilling the interlocking
hole might therefore be responsible for the
inaccuracies observed. This problem has been
addressed by the manufacturer and drill guides that
can be tracked are now available.
Limitations of our study include the lack of ran-
domization in the assignment of patients into
groups I and II but the anaesthetic risk score clearly
does not introduce a bias. There was a potential for
user bias because the surgeon could not be blinded
with respect to the method used for guidance.
To decide between slight contact or no contact
573
between drill bit and nail was subjective. This has
to be mentioned when interpreting the numbers
on interlocking holes passed through with minor
precision-related problems or with no precision-
related problems.
These limitations notwithstanding, this prospec-
tive study on distal locking of intramedullary
implants showed that fluoroscopic times to achieve
equivalent precision are reduced with fluoroscopy-
based surgical navigation compared with fluoro-
scopic guidance. The authors do not advocate
using fluoroscopy-based surgical navigation in
every procedure possible. Fluoroscopy-based sur-
gical navigation is recommended for intraopera-
tive guidance in situations where reduction of
exposure to radiation is considered advantageous
over the demand of resources and overall procedure
time.
Acknowledgements
This study was supported by the Swiss National
Science Foundation (SNSF) Grant No. 3200-059
222.99. Other than clinical research money, no
additional benefits have been received. The authors
thank Lisa Churchill and Bernhard Suhm for their
assistance in the preparation of this manuscript and
the Anaesthetic Department and the operating
room staff for continuous cooperation during this
study.
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