title: Pulsed electromagnetic field stimulation for acute tibial shaft fractures: a multicenter, double-blind, randomized trial.
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.
authors.affiliation: Orthopaedic Department, Liverpool Hospital, Locked Bag 7103, Liverpool BC, NSW Australia. sam.adie@gmail.com
authors.forename: Sam
authors.initials: S
authors.lastname: Adie
authors.forename: Ian A
authors.initials: IA
authors.lastname: Harris
authors.forename: Justine M
authors.initials: JM
authors.lastname: Naylor
authors.forename: Hamish
authors.initials: H
authors.lastname: Rae
authors.forename: Alan
authors.initials: A
authors.lastname: Dao
authors.forename: Sarah
authors.initials: S
authors.lastname: Yong
authors.forename: Victoria
authors.initials: V
authors.lastname: Ying
mesh_terms: D000328:Adult; D016001:Confidence Intervals; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D005592:Fracture Fixation / Q000379:methods; D017102:Fracture Healing / Q000502:physiology*; D005599:Fractures, Ununited / Q000000981:diagnostic imaging / Q000628:therapy*; D006801:Humans; D015601:Injury Severity Score; D055909:Magnetic Field Therapy / Q000379:methods*; D008297:Male; D015999:Multivariate Analysis; D011446:Prospective Studies; D011859:Radiography; D012016:Reference Values; D012044:Regression Analysis; D018570:Risk Assessment; D013978:Tibial Fractures / Q000000981:diagnostic imaging / Q000601:surgery / Q000628:therapy*; D016896:Treatment Outcome