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Scientific Articles   |    
Pulsed Electromagnetic Field Stimulation for Acute Tibial Shaft FracturesA Multicenter, Double-Blind, Randomized Trial
Sam Adie, BSc(Med), MBBS, MSpMed, MPH1; Ian A. Harris, MBBS, MMed(Clin Epi), FRACS, PhD1; Justine M. Naylor, BAppSc, PhD1; Hamish Rae, MBBS, MMed(Clin Epi)1; Alan Dao, MBBS1; Sarah Yong, MBBS, MIPH1; Victoria Ying, BSc1
1 Orthopaedic Department, Liverpool Hospital, Locked Bag 7103, Liverpool BC, NSW Australia 1871. E-mail address for S. Adie: sam.adie@gmail.com
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Disclosure: None of the authors received payments or services, either directly or indirectly (i.e., via his or her institution), from a third party in support of any aspect of this work. One or more of the authors, or his or her institution, has had a financial relationship, in the thirty-six months prior to submission of this work, with an entity in the biomedical arena that could be perceived to influence or have the potential to influence what is written in this work. No author has had any other relationships, or has engaged in any other activities, that could be perceived to influence or have the potential to influence what is written in this work. The complete Disclosures of Potential Conflicts of Interest submitted by authors are always provided with the online version of the article.

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Investigation performed at the Orthopaedic Department, Liverpool Hospital, Liverpool, New South Wales, Australia

Copyright © 2011 by The Journal of Bone and Joint Surgery, Inc.
J Bone Joint Surg Am, 2011 Sep 07;93(17):1569-1576. doi: 10.2106/JBJS.J.00869
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Abstract

Background: 

Tibial shaft fractures are sometimes complicated by delayed union and nonunion, necessitating further surgical interventions. Pulsed electromagnetic field stimulation is an effective treatment for delayed unions and nonunions, but its efficacy in preventing healing complications in patients with acute fractures is largely untested. The purpose of this pragmatic trial was to determine whether adjuvant pulsed electromagnetic field therapy for acute tibial shaft fractures reduces the rate of surgical revision because of delayed union or nonunion.

Methods: 

In a double-blind randomized trial involving six metropolitan trauma hospitals, 259 participants with acute tibial shaft fractures (AO/OTA type 42) were randomized by means of external allocation to externally identical active and inactive pulsed electromagnetic field devices. Participants were instructed to wear the device for ten hours daily for twelve weeks. Management was otherwise unaltered. The primary outcome was the proportion of participants requiring a secondary surgical intervention because of delayed union or nonunion within twelve months after the injury. Secondary outcomes included surgical intervention for any reason, radiographic union at six months, and the Short Form-36 Physical Component Summary and Lower Extremity Functional Scales at twelve months. Main analyses were by intention to treat.

Results: 

Two hundred and eighteen participants (84%) completed the twelve-month follow-up. One hundred and six patients were allocated to the active device group, and 112 were allocated to the placebo group. Compliance was moderate, with 6.2 hours of average daily use. Overall, sixteen patients in the active group and fifteen in the inactive group experienced a primary outcome event (risk ratio, 1.02; 95% confidence interval, 0.95 to 1.14; p = 0.72). According to per-protocol analysis, there were six primary events (12.2%) in the active, compliant group and twenty-six primary events (15.1%) in the combined placebo and active, noncompliant group (risk ratio, 0.97; 95% confidence interval, 0.86 to 1.10; p = 0.61). No between-group differences were found with regard to surgical intervention for any reason, radiographic union, or functional measures.

Conclusions: 

Adjuvant pulsed electromagnetic field stimulation does not prevent secondary surgical interventions for delayed union or nonunion and does not improve radiographic union or patient-reported functional outcomes in patients with acute tibial shaft fractures.

Level of Evidence: 

Therapeutic Level I. See Instructions to Authors for a complete description of levels of evidence.

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    Accreditation Statement
    These activities have been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of the American Academy of Orthopaedic Surgeons and The Journal of Bone and Joint Surgery, Inc. The American Academy of Orthopaedic Surgeons is accredited by the ACCME to provide continuing medical education for physicians.
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