Study protocol

Pulsed electromagnetic fields after arthroscopic treatment for osteochondral defects of the talus: double-blind randomized controlled multicenter trial

Christiaan JA van Bergen¹ , Leendert Blankevoort¹ , Rob J de Haan² , Inger N Sierevelt¹ , Duncan E Meuffels³ , Pieter RN d'Hooghe⁴ , Rover Krips⁵ , Geert van Damme⁶ and C Niek van Dijk¹

¹  Orthopaedic Research Center Amsterdam, Department of Orthopaedic Surgery, Academic Medical Center, Amsterdam, The Netherlands

²  Department of Clinical Epidemiology and Biostatistics, Academic Medical Center, Amsterdam, The Netherlands

³  Department of Orthopaedic Surgery, Erasmus MC, University Medical Center Rotterdam, The Netherlands

⁴  Department of Orthopaedic Surgery, Stedelijk Ziekenhuis, Roeselare, Belgium

⁵  Department of Orthopaedic Surgery, Diaconessenhuis, Leiden, The Netherlands

⁶  Department of Orthopaedic Surgery, Algemeen Ziekenhuis Sint Lucas, Brugge, Belgium

author email corresponding author email

BMC Musculoskeletal Disorders 2009, 10:83doi:10.1186/1471-2474-10-83

Published:	10 July 2009

Abstract

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/Design

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.

Discussion

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

Trial registration

Netherlands Trial Register (NTR1636)