Assiotis et al.

Journal of Orthopaedic Surgery and Research 2012, 7:24

http://www.josr-online.com/content/7/1/24

RESEARCH ARTICLE Open Access

Pulsed electromagnetic fields for the treatment

of tibial delayed unions and nonunions. A
prospective clinical study and review of
the literature
Aggelos Assiotis1, Nick P Sachinis2 and Byron E Chalidis2*

Abstract
Background: Pulsed electromagnetic fields (PEMF) stimulation for the treatment of bone nonunion or delayed
union have been in use for several years, but on a limited basis. The aim of this study was to assess the overall
efficacy of the method in tibial delayed unions and nonunions and identify factors that could affect the final
outcome.
Methods: We prospectively reviewed 44 patients (27 men) with a mean age of 49.6 ± 18.4 years that received PEMF
therapy due to tibial shaft delayed union or nonunion. In all cases, fracture gap was less than 1 cm and infection or
soft tissue defects were absent.
Results: Fracture union was confirmed in 34 cases (77.3%). No relationship was found between union rate and age
(p = 0.819), fracture side (left or right) (p = 0.734), fracture type (simple or comminuted, open or closed) (p = 0.111),
smoking (p = 0.245), diabetes (p = 0.68) and initial treatment method applied (plates, nail, plaster of paris) (p = 0.395).
The time of treatment onset didn’t affect the incidence of fracture healing (p = 0.841). Although statistical
significance was not demonstrated, longer treatment duration showed a trend of increased probability of union
(p = 0.081).
Conclusion: PEMF stimulation is an effective non-invasive method for addressing non-infected tibial union
abnormalities. Its success is not associated with specific fracture or patient related variables and it couldn’t be
clearly considered a time-dependent phenomenon.
Keywords: PEMF, Tibia, Fracture, Nonunion, Delayed union

Background a form of biological enhancement, such as bone grafting,

It has been traditionally quoted that 5-10% of fractures is considered the ‘gold standard’ for the treatment of
worldwide may develop delayed union or nonunion [1]. nonunions [2]. However, non-invasive treatment options
Considering that in United States alone the number of including low-intensity pulsed ultrasound (LIPUS),
fractures is 7.9 million annually, it is widely accepted extra-corporeal shock wave therapy, electrical and
that fracture union abnormalities have a significant clin- pulsed electromagnetic fields (PEMF) stimulation have
ical and financial impact on health care systems [1]. Sur- been also suggested for the management of nonunited
gical management with debridement of necrotic tissue fractures [3].
and rigid fixation (either internal or external) along with We present the results of PEMF stimulation in treating
non-infected tibial delayed unions and nonunions. Fac-
tors that might affect the success of the method were
* Correspondence: [email protected] investigated and a thorough literature review was also
2
Interbalkan Medical Center, 10 Asklipiou Str, Pilaia, Thessaloniki 57001,
Greece conducted to assess the overall efficacy of the method in
Full list of author information is available at the end of the article tibial nonunited fractures.
© 2012 Assiotis et al.; Licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative
Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and
reproduction in any medium, provided the original work is properly cited.
Assiotis et al. Journal of Orthopaedic Surgery and Research 2012, 7:24 Page 2 of 6
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Methods serial anteroposterior and lateral X-Rays until fracture

We prospectively evaluated 52 consecutive patients with union occurred or further operation took place. The
tibial shaft delayed union (and nonunion who were trea- plain radiographs were reviewed in order to assess the
ted with a battery-powered PEMF device (Physio-Stim, initial fracture type and progress of fracture healing. The
Orthofix) (Figure 1). Eight patients were excluded from absence of either adequate fracture callus in a minimum
the study due to lost to follow-up (5 patients), non- period of 9 months or progression toward healing for 3
attendance the outpatient appointments (2 patients) and consecutive months was defined as nonunion. Delayed
severe vascular dementia (1 patient) leaving 44 patients union was assumed when no union was achieved at 20–
for further evaluation. The medical records of these 26 weeks postoperatively. The fracture considered to be
patients were assessed with the approval of the hospital's healed when radiographic evidence of bridging callus
institutional review board. formation was seen in at least three cortexes.
In accordance with the manufacturer guidelines, the
system was applied 3 hours per day, for a maximum Statistics
period of 36 weeks. Further weight-bearing restrictions Statistical analysis was performed with the use of SPSS
or fracture immobilization were not applied. The frac- 17. Variables were tested using normality plots and the
ture gap in all cases was less than 1 cm and the bone de- Kolmogorov-Smirnov test (with 0.200 considered as the
fect less than one-half the width of the bone to be lower boundary of true significance). Non-parametric
treated. Patients with infective nonunion or severe soft- numerical variables are presented as median, with range
tissue defect were not deemed candidates for the PEMF between round brackets and were compared with the
stimulation regime. Mann–Whitney U test. Normally distributed numerical
The device was prescribed by the treating orthopaedic data are presented as mean with standard deviation (SD
surgeon during the outpatient clinic reviews. The pre- is symbolized with ±) in brackets and were compared
scription was then reviewed by the Clinical Director of using the student’s t-test. The Chi-square test was used
the department and was supplied by the senior plaster to study categorical variables. Correlation between scale
technician, who was in direct communication with the variables was analyzed with Spearman’s rho. Kaplan-
manufacturer. Patients were monthly followed-up using Meier survivorship curve was used for analysis of the
probability of fracture union. Statistical significance was
assumed at p < 0.05.

Results
Demographics
There were 17 women and 27 men with a mean age of
49.6 ± 18.4 years. The left limb was affected in 25
patients and the right in 19 patients. Fifteen out of the
44 patients were smokers. Diabetes was present in 5
patients.
From a total of 44 fractures, 17 were simple closed
fractures, 10 were comminuted closed fractures, 8 were
Grade I open fractures, 3 were Grade II open fractures,
4 Grade IIIA open fractures and 2 Grade IIIB open frac-
tures (according to Gustilo-Anderson classification [4]).
The fractures were initially treated with external fixator
(6 cases), intramedullary nail (12 cases), plating without
bone grafting (10 cases), plate with bone-grafting (7
cases), or Plaster of Paris (POP) (9 cases).

Union
Fracture union was achieved in 34 out of 44 cases (77.3%)
(Figures 2 & 3). The 10 nonunions were observed in 2
simple closed fractures (1 smoker), in 3 comminuted
closed fractures (one smoker), in 2 Grade I open fractures
(one smoker), in 2 Grade IIIA open fractures (one
smoker) and in one Grade IIIB open fracture (one dia-
Figure 1 PEMF device (Physio-Stim, Orthofix).
betic). No statistical significant relationship was found
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Figure 2 Anteroposterior (a) and lateral radiographs (b) of a distal tibial nonunion 10 months after fracture. PEMF stimulation of fracture
site led to fracture union 5 months thereafter as shown in anteroposterior (c) and lateral (d) tibial views.

between union rate and age (t-test, p = 0.819), smoking presented in Figure 4. Although statistical significance
status (chi-square test, p = 0.245), diabetes (chi-square test, was not demonstrated, the curve shows a trend of
p = 0.681), (fracture side (left or right) (chi-square test, increased probability of healing after longer application
p = 0.734), fracture type (simple or comminuted, open or of the device.
closed) (chi-square test, p = 0.111) and initial treatment
method applied (p = 0.395, chi-square test). Discussion
The median time interval between the latest fracture The use of electrical stimulation in fracture healing is
management and the introduction of PEMF was not a novel concept. There have been relevant reports
24.5 weeks (21–57 weeks). The median duration of from as early as 1841 [1] but the use of this method did
PEMF application was 29.5 weeks (8–36 weeks). No cor- not become widespread until the early 1950s, when
relation was observed between these two time variables Yasuda [5] demonstrated new bone formation in rabbit
(p = 0.348, r = 0.145, spearman rho test). Similarly, no as- femora, adjacent to a cathode. He also demonstrated
sociation was found between the above time variables that there were electric potentials in bones, that were
and the overall union rate (p = 0.081 and p = 0.841, re- categorized into steady-state and stress-induced poten-
spectively, Mann Whitney U test). The probability of tials [5]. The latter develop when a bone is subjected to
fracture union in relation to duration of PEMF is a bending force, which causes the compressed side to

Figure 3 Anteroposterior (a) and lateral radiographs (b) of an open Grade I distal tibial fracture. Six months after surgery, anteroposterior
(c) and lateral tibial radiographs (d) showed slow progression of healing. Seven months after PEMF introduction, anteroposterior (e) and lateral
tibial radiographs (f) showed bridging callus in 3 out of 4 cortexes (medial, anterior and posterior).
Assiotis et al. Journal of Orthopaedic Surgery and Research 2012, 7:24 Page 4 of 6
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The principle underlying the application of PEMF is

that of inductive coupling [6,11]. The electric current is
produced by a coil, driven by an external field generator.
The outcome is a secondary electrical field produced in
the bone [1]. The secondary field is dependent on the
characteristics of the applied magnetic field and tissue
properties. Magnetic fields varying from 0.1 to 20 G are
usually applied in order to produce electrical fields in
bone, ranging from 1 to 100 mV/cm [11]. Contra-
indications to the use of PEMF include segmental bone
loss, infected nonunions, synovial pseudarthrosis and
poor stability of fracture site [11].
As opposed to other methods of non-invasive augmen-
tation of fracture healing, such as low-intensity pulsed
ultrasound (LIPUS), PEMF have not been assessed thor-
oughly in robust studies of high methodological quality
[1]. Despite the relative scarcity of well-organized rando-
mized controlled trials, many in vivo and in vitro studies
highlight the method’s potential usefulness [11]. Particu-
larly and in terms of clinical practice, the efficacy quoted
Figure 4 Kaplan-Meier recurrence curve of patients treated in treating tibial delayed unions or nonunions has been
with PEMF. Line represents probability of fracture union in relation reported to range between 45% and 87% [12-20]
to the duration of PEMF treatment (weeks). Crosses represent (Table 1).
censored cases where follow-up was stopped because union was
deemed unlikely with conservative management.
One of the first series that examined the results of
PEMF treatment on delayed unions was published in
1980 by De Haas et al [15]. Their series comprised of 17
become negatively charged when compared to the patients with tibial fracture abnormalities and the
tensed side of the bone [6]. Steady-state potentials are reported healing rate was 88.2%. Despite the small sam-
potentials that arise in areas of bone activity and are in- ple size and lack of randomization and blinding, this
dependent to stresses. study was considered significant, as it was the first that
Until the late 1970s there was an abundance in the lit- demonstrated the potential benefit of PEMF in promot-
erature of reports describing the effects of electricity on ing fracture healing.
bone growth and fracture repair [1]. Since then, a variety Bassett et al [13] reported a case series of 127 non-
of devices have been developed in order to produce elec- united or delayed united tibial fractures that treated with
tromagnetic fields to the fracture site. Recent and more PEMF. Patients were recruited over a 5-year period after
widespread PEMF devices utilize non-invasive inductive an average of 2.4 failed surgical interventions prior to
coupling and can be used along with every method of PEMF application. PEMF were applied for a mean
fracture fixation [7]. Interestingly, the electrical stimula- period of 5.2 months and the patients were advised to
tion market is approximately worth 500 million dollars remain non-weight bearing. The overall healing rate was
in the United States [8]. 87%. Sharrard et al [17] found a 86.7% successful out-
It seems that the introduction of electromagnetic fields come in 53 tibial nonunions that treated with a PEMF
at the fracture site can stimulate the bone in a way simi- system. The authors advocated that infection, a screw in
lar to mechanical loading [1]. However, there is still on- the fracture gap, a gap of more than 5 mm and inad-
going debate regarding the mechanism of action of equate immobilization were responsible for treatment
PEMF at cellular and molecular level. PEMF have been failure. Gupta et al [19] studied prospectively 45 tibial
advocated to stimulate the synthesis of extracellular atrophic nonunions without infection, presence of
matrix proteins and exert a direct effect on the produc- implants or fracture gap more than 1 cm. Healing was
tion of proteins that regulate gene transcription [9]. achieved in 85% of cases during a 4-month period. Poor
Electromagnetic fields may also affect several membrane compliance was considered responsible for the three
receptors including PTH, insulin, IGF-2, LDL and calci- persistent nonunions.
tonin receptors [10]. Moreover, when osteoblasts are sti- A randomized double-blind clinical trial examining 34
mulated by PEMF, they secrete several growth factors tibial nonunions demonstrated a statistically significant
such as bone morphogenic proteins 2 and 4 and TGF- increase in union rate when a PEMF device was admi-
beta [6,11]. nistered [18]. However, a recent meta-analysis, which
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Table 1 Summary of clinical studies using Pulsed Electromagnetic Field therapy in tibial delayed unions and
nonunions
Study Year Design Number of Mean treatment Hours per day Union rate
tibia fractures duration
De Haas (17) 1980 Prospective, non-randomized 17 23.6 weeks 20 88.2%
Bassett (15) 1981 Prospective, non-randomized 127 5.2 months 10 87%
Sharrard (19) 1982 Prospective, non-randomized 30 6 months 12 to 16 86.7%
Barker (14) 1984 Prospective, randomized, double-blind 16 24 weeks 12 to 16 55.6%
De Haas (16) 1986 Prospective, non-randomised 56 ND ND 84%
Sharrard (18) 1990 Prospective, randomized, double-blind 45 12 weeks 12 45%
Scott (22) 1994 Prospective, randomized, double-blind 15 26.8 weeks ND 60%
Simonis (20) 2003 Prospective randomized, double-blind 34 6 months ND 70.6%
Gupta (21) 2009 Prospective, non-randomized 45 8.35 weeks ND 85%
Current study 2011 Prospective, non-randomized 44 29.5 weeks 3 77.3%
ND: Not Defined.

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doi:10.1186/1749-799X-7-24
Cite this article as: Assiotis et al.: Pulsed electromagnetic fields for the
treatment of tibial delayed unions and nonunions. A prospective clinical
study and review of the literature. Journal of Orthopaedic Surgery and
Research 2012 7:24.

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