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Early PEMF therapy improves union success rates for delayed unions of long-bone fractures
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May 2014
Early PEMF therapy improves union success rates for delayed unions of long-bone fractures
Study Type:Therapy
OE Level Evidence:2
Journal Level of Evidence:N/A
Early application of pulsed electromagnetic field in the treatment of postoperative delayed union of long-bone fractures: a prospective randomized controlled study
BMC Musculoskelet Disord. 2013 Jan 19;14:35. doi: 10.1186/1471-2474-14-35.Did you know you're eligible to earn 0.5 CME credits for reading this report? Click Here
Synopsis
64 patients with delayed union following a long-bone fracture were randomized to receive either an active or sham treatment of pulsed electromagnetic field (PEMF) therapy between 16 weeks and 6 months postoperatively to determine whether early application of PEMF is effective in improving union success rates in these patients. Results indicated that, although union success rates were similar between groups at the 3-month assessment, PEMF therapy was associated with a significantly higher union success rate at study completion, compared to the control group (77.4% versus 48.1%). The average length of treatment at the end of the study was similar between groups.
Publication Funding Details
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Funding:
Non-Industry funded
Sponsor:
Starting Grant for Young Scientific and Technological Talents (Nanjing Health Bureau), the Key Program of Nanjing Medical Science and Technique Development Foundation, and the Fundamental Research Funds for the Central Universities
Conflicts:
None disclosed
Was the allocation sequence adequately generated?
Was allocation adequately concealed?
Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?
Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?
Blinding Patients: Was knowledge of the allocated interventions adequately prevented?
Was loss to follow-up (missing outcome data) infrequent?
Are reports of the study free of suggestion of selective outcome reporting?
Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?
Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?
Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?
Yes = 1
Uncertain = 0.5
Not Relevant = 0
No = 0
The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.
3/4
Randomization
4/4
Outcome Measurements
4/4
Inclusion / Exclusion
3/4
Therapy Description
4/4
Statistics
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
The Fragility Index is a tool that aids in the interpretation of significant findings, providing a measure of strength for a result. The Fragility Index represents the number of consecutive events that need to be added to a dichotomous outcome to make the finding no longer significant. A small number represents a weaker finding and a large number represents a stronger finding.
Why was this study needed now?
A common complication associated with treatment of fractures is delayed union or nonunion. Conservative treatments to promote bone healing are typically administered when these fractures are infection- and defect-free. One approach - pulsed electromagnetic field (PEMF) therapy - has previously been found to be effective, although the mechanism by which it carries out this effect is not well-known. Furthermore, some studies begin this treatment well after delayed union has been diagnosed (i.e. >6 months post-fracture), while others wait until nonunion is officially diagnosed. This study was needed to examine the efficacy of PEMF when applied early on, immediately following diagnosis of delayed union (i.e. approximately 16 weeks post-fracture).
What was the principal research question?
Is pulsed electromagnetic field (PEMF) therapy effective in improving bone healing in patients with postoperative delayed union following a long-bone fracture?
Study Characteristics
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Population:
64 patients with postoperative delayed union following a long-bone fracture (i.e. failure to heal 16 weeks-9 months postoperatively). Healing was considered "failed" when callus bridging was absent in more than 3 cortices via biplane radiographs. Treatment was initiated between 16 weeks and 6 months postoperatively. Treatment was discontinued if: (1) patients demonstrated radiological union or (2) patients did not demonstrate any progress to union for a 3 month period.
Intervention:
PEMF treatment group: Immediately after enrollment in the study, patients (n=31) received pulsed electromagnetic field (PEMF) therapy for 8 hours per day. This treatment consisted of a coil (Orthopulse II, OSSATEC, Uden, The Netherlands) which was placed directly over the fracture site and provided an electromagnetic field at a signal adjusted according to Punt et al. (Mean age: 41.1 years [SD 14.5])
Comparison:
Control group: Immediately after enrolling in the study, patients (n=27) received a sham signal generator for 8 hours per day. The coil used in this group was manufactured by the same company as the one used in the treatment group. (Mean age: 38.4 years [SD 11.6])
Outcomes:
Clinical outcomes included pain when stressed and during motion at the fracture site. Furthermore, anteroposterior an lateral radiographs were examined for cortical bridging. Union was defined as no pain (neither when stressed nor during motion) and callus bridging in 3/4 cortices on orthogonal radiographs.
Methods:
RCT; Single Centre; Double-blinded (patients & assessors)
Time:
Treatment efficacy was assessed at 3-month intervals.
What were the important findings?
- At 3 months, union success was found in 12 patients (38.7%) in the treatment group and 6 patients (22.2%) in the control group, a non-significant difference (RR 1.74; p=0.256).
- At study completion, the union success rate was significantly greater in the treatment group (24/31 or 77.4%; 95% CI 0.58 to 0.90) compared to the control group (13/27 or 48.1%; 95% CI 0.28 to 0.68) (RR 1.61; p=0.029).
- The average length of treatment was similar between groups at the end of the study (treatment: 4.8 months; control: 4.4 months) (p=0.489).
What should I remember most?
Although union success rates were similar between groups at the 3-month assessment, pulsed electromagnetic field (PEMF) therapy was associated with a significantly higher union success rate compared to the control group at study completion (77.4% versus 48.1%). The average length of treatment at the end of the study was similar between groups.
How will this affect the care of my patients?
Results from this study support the early application (i.e. 16 weeks to 6 months postoperatively) of pulsed electromagnetic field (PEMF) therapy in the treatment of patients with delayed union of long bone fractures. These findings are limited by varying degrees of damage in each patient, the small number of patients for each fracture location, and variability in the patients' activity levels. Future studies should determine whether there is a difference in patient outcome whether PEMF is administered at 16 weeks versus 6 months postoperatively.
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