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Eur J Orthop Surg Traumatol (2007) 17:363366

DOI 10.1007/s00590-007-0199-z

O R I G I N A L A RT I C L E

Low-intensity pulsed ultrasound in the treatment of tibial


non-union
Suraj Joshy Suresh Gopalan S. C. Deshmukh

Received: 13 September 2006 / Accepted: 8 December 2006 / Published online: 1 February 2007
Springer-Verlag 2007

Abstract Non-union is still a major challenge to the


orthopaedic surgeon and established non-union has
zero probability of achieving union with out intervention. The purpose of this study was to evaluate the
effect of low-intensity ultrasound in the treatment of
tibial non-union. The study was done retrospectively
by reviewing the case notes and radiographs. There
were eight patients who received low-intensity pulsed
ultrasound treatment as a treatment for tibial non-union. One patient who was noncompliant to the treatment was excluded from the study. Bony union was
achieves in all the seven patients with an average
healing time of 29 weeks (range 1648 weeks). This
study shows that low-intensity ultrasound is a simple
and safe way to treat tibial non-unions.
Keywords

Tibia  Non-union  Ultrasound

Ultrasons a` basse frequence dans le traitement


de la pseudarthrose du tibia
Resume Ultrasons a` basse frequence dans le traitement de la pseudarthrose du tibia La pseudarthrose
constitue toujours un challenge pour le chirurgien
orthopediste, car il est etabli quune pseudarthrose
na pratiquement pas de chance de guerir sans
S. Joshy  S. Gopalan  S. C. Deshmukh
Trauma and Orthopaedics,
City Hospital, Birmingham, UK
S. Joshy (&)
27 Waun-Y-Groes Road, Cardiff CF14 4SW, UK
e-mail: surajjoshy@yahoo.co.uk

intervention. Le but de cette etude est devaluer laction dultrasons a` basse frequence dans le traitement
de la pseudarthrose du tibia. 8 patients ont donc
beneficie de cette therapeutique. Un patient netait finalement pas consentant et a ete exclu du protocole.
Pour les 7 autres patients, la consolidation.
Mots cles

Tibia  Pseudarthrose  Ultrasons

Introduction
Non-union continues to be a major challenge to the
orthopaedic surgeon. Established non-union has a
zero probability of achieving union with out any
intervention [3, 7]. Stabilisation and bone grafting is
the gold standard in the treatment of non-union [11].
Depending on the location of non-union literature
reports a success rate of 7096% for the first surgical
procedure [7].
Non-operative treatment for non-union includes,
electrical stimulation, extra-corporeal shock wave
therapy and low-intensity pulsed ultrasound. Previous
studies have demonstrated accelerated healing following application of low-intensity pulsed ultrasound [2, 4,
5]. Prospective randomised double blind studies in
humans have demonstrated 40% acceleration of time
to healing in tibial fractures [5].
Previous studies have reported a success rate of 70
80% in the treatment of non-unions with low-intensity
ultrasound [7].
The purpose of this study was to evaluate the effect
of low-intensity ultrasound specifically for the treatment of tibial non-unions.

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Eur J Orthop Surg Traumatol (2007) 17:363366

Materials and methods


The study was done retrospectively by reviewing the
case notes and the radiographs. All patients who
underwent low-intensity pulsed ultrasound treatment
for non-union of tibia, in the period between 2000
February and 2005 January, were included in the study.
The time between initial injury to the commencement
of ultrasound treatment and the interval from the date
of last surgical procedure to start of ultrasound treatment were verified from records.
All patients received low intensity pulsed ultrasound
daily for a duration of 20 min. The equipment used
(Exogen, Smith & Nephew) has facility for automatic
shut off and compliance monitoring. The device
delivered ultrasound signal composed of burst width of
200 ls containing 1.5 MHz sine waves. The average
intensity is 30 mW/cm2 and ultrasound is applied to the
skin surface overlying the fracture site. The ultrasound
signal is transmitted to the skin via a conductive coupling gel, which coats the skin surface. In the event a
cast is present, a hole is created in the cast so the device
can be applied to the skin.
The minimum time period between initial injury
and the commencement of ultrasound treatment was
set as 6 months. In this study the definition of nonunion was non-progression of clinical and radiographic healing for a period of 6 months. The interval
between the last operative procedure and start of
ultrasound treatment was set as minimum of
3 months. This was to minimise the effect of any
concomitant surgery interfering with the results of
ultrasound treatment.
The initial criteria to commence ultrasound treatment were:
1.
2.
3.
4.

At least 6 months have passed since the date of the


fracture.
Serial radiographs confirm that no progressive
signs of healing have occurred.
The fracture gap is 1 cm or less.
The individual can be adequately immobilized and
is likely to comply with non-weight bearing if required.

Patients who had any operative intervention within


a period of 3 months prior to commencement of
ultrasound treatment were excluded from the study.
The end point of the study was a healed fracture both
on clinical and radiological evaluation.
Treatment was considered to be failed if the patient
required any other intervention in the form of surgical
stabilisation or bone grafting with in 3 months of
commencing the low intensity pulsed, ultrasound

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therapy. Treatment was also considered to be failure if


there was no clinical or radiological, signs indicating
the progress of healing for a period of 3 months after
starting ultrasound.
The treatment was considered successful if there was
clinical and radiological union of the fracture while on
treatment with ultrasound. Union was defined clinically as absence of tenderness and movement of fracture site. Radiologically union was defined as
continuity of bone or bridging callus on at least three
cortices in two planes.
A total of eight patients received low-intensity
pulsed ultrasound for the treatment of tibial non-union
during the study period. One patient was excluded
from the study because of non-compliance. This patient discontinued the treatment after 6 weeks of
commencement of the ultrasound.

Results
There were a total of seven patients who met the
inclusion criteria of the study. The mean age was
56 years (range 3774 years). Five patients were male
and two female. Five patients had closed fracture
and two had open fracture (one grade II and one
grade III, Gustilo Anderson classification). Intial
treatment was conservative in three patients
(Manipulation under anaesthesia and plaster cast),
and operative in the rest. In the operative group two
patients underwent intramedulary nailing, and two
had external fixation. Two patients had infected nonunion. The non-union was atrophic in five cases and
hypertrophic in two.
The average time to commencement of ultrasound
treatment after the initial fracture was 42 weeks (range
2660 weeks).
In this study the outcome variable attributable to
ultrasound treatment is healing of the fracture. Since
established non-union has zero probability of
achieving a healed status with out intervention we
could assume the healing rate with out intervention
as zero percentage. Since the numbers available are
small we did not consider any such statistical analysis.
All patients except the one excluded from the study
were compliant with the use of the device and no side
effects were recorded. Bony union was achieved in all
the seven patients. The average time to union was
29 weeks (range 1648 weeks). Detailed information
about individual patients and fracture characteristics is
given in Table 1.

Proximal third Closed


Union
Diabetes/renal
failure

Proximal third Closed


Middle third
Closed
Diabetes/old age Union
Infection
Union

Open
Middle third
Union
Infection

Middle third
Closed
Proximal third Open
Union
Union
Diabetic
Severe
Osteoporosis

Closed
Distal third
Union
Nil

No
22
52
74

Female MUA/POP Atrophic

No
Yes
20
38
28
36

Male

Male
Male
73
61
5
6

MUA/POP Atrophic
IM nail
Hyper Tr

Yes
48
27
Atrophic
48
4

IM nail

37
63
2
3

Male
MUA/POP Atrophic
Female Ex fix
Atrophic

26
60

32
16

Yes
Yes

Removal of Ex fix followed


by plaster cast 20 week
prior to ultrasound
Nil
Fibular osteotomy and bone
graft 40 weeks prior to
ultrasound treatment
Exchange nailing for infection
16 weeks prior to ultrasound
Nil
Exchange nailing for infection
18 weeks prior to ultrasound
IM nail 32 weeks prior to
ultrasound
No
28
52
Hyper Tr
Ex fix
38
1

Male

Initial
treatment
Number Age Sex

Table 1 Details of patients

Type of
Fracture age Duration of Smoker Secondary surgical
non-union in weeks
ultrasound
procedures
in weeks

Comorbid
factors

Outcome Location of
fracture

Open/
closed

Eur J Orthop Surg Traumatol (2007) 17:363366

365

Discussion
This study looked at the effect of low-intensity pulsed
ultrasound in tibial non-union. The exact mechanism
by which the ultrasound influences bone healing is still
unknown [5]. Ultrasound influences several stages of
healing process including signal transduction, gene
expression, blood flow and tissue remodeling [4]. The
key attribute to ultrasound is that it influences on
several critical aspects of healing at several distinct
stages [4].
None of the placebo treated non-unions had
achieved union in previously reported trials [1, 810].
This underlines the need for intervention in established
non-unions. Randomised or placebo control trials
which denies treatment for one group are impractical
and unethical in this situation.
The success rate in achieving union in our study was
100%. High union rate in non-unions had been previously reported with the use of ultrasound [6, 7]. But
this study specifically considered tibial non-unions. In
this study we included patients with open fractures
regardless of the grade. The non-unions were confirmed as well established both clinically and radiologically.
Because of our strict exclusion and inclusion criteria,
the healing of the fracture could be associated primarily to ultrasound treatment. The average fracture
age in the study was 42 weeks. Since only tibia was
included in the study this gives relative homogeneity
for the group. Even open fractures and infected nonunions responded well to the ultrasound treatment.
The main drawback of the study is the small number
of cases in the series and absence of a well-defined
control group. More over if we apply a more stringent
criterion for non-union as 9 months time period after
initial injury only three patients could be considered to
have non-union. In that case rest of the patients could
only be considered as delayed union. Our study group
was a mixture of open and closed fractures as well as
hyper-trophic and atrophic non-unions. Since placebo
controlled trials are impractical and unethical in
treating non-unions, larger multi-centric retrospective
studies comparing specific bones and specific fracture
types could provide more information about which
non-unions are best suited for ultrasound treatment.
This study shows low intensity ultrasound is an
effective way of treating non-unions and delayed unions of tibia. Because ultrasound intervention is noninvasive, it represents an effective combination of
conservative and aggressive treatment for non-union.
Substantial reduction of secondary procedures can reduce the overall cost of treating non-unions. Moreover

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366

ultrasound treatment could be considered as a good


choice if patient is not keen on further surgical intervention. This study confirms that low intensity ultrasound application is safe, simple and cost effective
method to treat non-unions in tibia. Union could be
achieved using ultrasound treatment even in infected
and atrophic non-unions.

References
1. Barker AT, Dixon RA, Sharrad WJW et al (1984) Pulsed
magnetic field therapy for tibial non-union. Lancet 1:994996
2. El-Mowafi H, Mohsen M (2005) The effect of low-intensity
pulsed ultrasound on callus maturation in tibial distraction
osteogenesis. Int Orthop 29(2):121124
3. Forsted DL, Dalinka M, Mitchell E et al (1978) Radiological
evaluation of treatment of non-union of fractures by electrical stimulation. Radiology 128:629634
4. Hadjiargyrou M, McLeod K, Ryaby JP et al (1998)
Enhancement of fracture Healing by low intensity ultrasound. Clin Orthop Relat Res 355S:S216229

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Eur J Orthop Surg Traumatol (2007) 17:363366


5. Heckman JD, Ryaby JP, McCabe J et al (1994) Acceleration
of tibial fracture healing by non-invasive, low intensity
pulsed ultrasound. JBJS 76A(1):2634
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Surg 120:18
7. Nolte PA, Krans A, Patka P et al (2001) Low-intensity
pulsed ultrasound in the treatment of nonunions. J Trauma
Inj Infect Crit Care 51(4):693703
8. Parnell EJ, Simonis RB (1990) The effect of electrical
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Joint Surg Br 72:S178
9. Scott G, King JB (1994) Aprospective double blind trial of
electrical capactive coupling in the treatment of non-union of
long bones. J Bone Joint Surg Am 76:820826
10. Sharrad WJW (1990) A double blind trial of pulsed electromagnetic fields for delayed union of tibial fractures. J
Bone Joint Surg Br 72:347355
11. Weber BG, Cech O (1976) Pseudarthrosis. Hans Huber Publishers, Bern, pp 4550

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