Pulsed electromagnetic fields after arthroscopic treatment for osteochondral defects of the talus: double-blind randomized controlled multicenter trial.
BACKGROUND
Osteochondral talar defects usually affect athletic patients. The primary surgical treatment consists of arthroscopic debridement and microfracturing. Although this is mostly successful, early sport resumption is difficult to achieve, and it can take up to one year to obtain clinical improvement. Pulsed electromagnetic fields (PEMFs) may be effective for talar defects after arthroscopic treatment by promoting tissue healing, suppressing inflammation, and relieving pain. We hypothesize that PEMF-treatment compared to sham-treatment after arthroscopy will lead to earlier resumption of sports, and aim at 25% increase in patients that resume sports.


METHODS
A prospective, double-blind, randomized, placebo-controlled trial (RCT) will be conducted in five centers throughout the Netherlands and Belgium. 68 patients will be randomized to either active PEMF-treatment or sham-treatment for 60 days, four hours daily. They will be followed-up for one year. The combined primary outcome measures are (a) the percentage of patients that resume and maintain sports, and (b) the time to resumption of sports, defined by the Ankle Activity Score. Secondary outcome measures include resumption of work, subjective and objective scoring systems (American Orthopaedic Foot and Ankle Society--Ankle-Hindfoot Scale, Foot Ankle Outcome Score, Numeric Rating Scales of pain and satisfaction, EuroQol-5D), and computed tomography. Time to resumption of sports will be analyzed using Kaplan-Meier curves and log-rank tests.


CONCLUSIONS
This trial will provide level-1 evidence on the effectiveness of PEMFs in the management of osteochondral ankle lesions after arthroscopy.


BACKGROUND
Netherlands Trial Register (NTR1636).
van Bergen
Christiaan J A
CJ
Orthopaedic Research Center Amsterdam, Department of Orthopaedic Surgery, Academic Medical Center, Amsterdam, The Netherlands. c.j.vanbergen@amc.nl
Blankevoort
Leendert
L
de Haan
Rob J
RJ
Sierevelt
Inger N
IN
Meuffels
Duncan E
DE
d'Hooghe
Pieter R N
PR
Krips
Rover
R
van Damme
Geert
G
van Dijk
C Niek
CN
D000328:Adult; D016512:Ankle Injuries / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery / Q000628:therapy*; D001182:Arthroscopy; D001265:Athletic Injuries / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery / Q000628:therapy*; D001530:Belgium; D002358:Cartilage, Articular / Q000000981:diagnostic imaging / Q000293:injuries / Q000503:physiopathology / Q000601:surgery*; D003131:Combined Modality Therapy; D003646:Debridement; D004185:Disability Evaluation; D004311:Double-Blind Method; D004867:Equipment Design; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D055909:Magnetic Field Therapy / Q000295:instrumentation; D008297:Male; D009426:Netherlands; D011446:Prospective Studies; D020127:Recovery of Function; D012107:Research Design; D018582:Sick Leave; D013628:Talus / Q000000981:diagnostic imaging / Q000293:injuries / Q000503:physiopathology / Q000601:surgery*; D013997:Time Factors; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome