No significant benefit of PEMF on outcomes after debridement/microfracture for talar OCDs

Study Type: Therapy
OE Level of Evidence: 1
Journal Level of Evidence: 1
Synopsis
68 patients scheduled for arthroscopic debridement and microfracture for osteochondral defects (OCD) of the talus were randomized to postoperative rehabilitation with or without the use of pulsed electromagnetic field (PEMF) therapy. The purpose of this study was to test the hypothesis that the use of PEMF therapy postoperatively in these patients would increase the rate of return to sport and also reduce the time to return to sport. Results demonstrated no Please login to view the rest of this report. Please login to view the rest of this report.
Funding: Industry funded
Sponsor: Stryker; IGEA medical
Conflicts: None disclosed
CONTENT IS LOCKED
Why was this study needed now?
Arthroscopic debridement with microfracture is a common surgical intervention for osteochondral defects (OCD) of the talus, and while arthroscopy typically enjoys high success and patient satisfaction rates, postoperative recovery can be a lengthy process. Many patients with talar OCDs are young individuals who are active in sports, and a delayed or slow recovery in these patients may lead to patient dissatisfied. Therefore, augmentative interventions in the rehabilitation phase after arthroscopy are of keen interest. More specifically, the use of pulsed electromagnetic field (PEMF) therapy has been considered as a possible intervention to expedite postoperative recovery.
What was the principal research question?
Following arthroscopic debridement and microfracture for an osteochondral defect of the talus, does pulsed electromagnetic field therapy significantly improve the rate of return to sport and reduce the time to return to sport?
Population: 68 patients, 18 years of age or older, with a symptomatic osteochondral defect of the talus, <15mm on computed tomography, scheduled for arthroscopic debridement and microfracture, with a pre-symptom Ankle Activity Score of 4 or more. All procedures were standardized; unstable bone, cartilage, and cysts (if present) were removed, followed by microfracture of the subchondral bone at approximately 3mm intervals. Postoperative rehabilitation, with the exception of randomized treatment, was also standardized.
Intervention: PEMF group: Beginning at 3 days after surgery, patients were provided with a PEMF stimulator (I-ONE; IGEAmedical) and instructed to use the device for 4 hours/day for 60 days. The device was set to a peak magnetic field intensity of 1.5mT and a frequency of 75Hz. (n=36; Mean age: 32+/-10)
Comparison: Placebo group: Beginning at 3 days after surgery, patients were provided with a PEMF stimulator (I-ONE; IGEAmedical), though the device was set to deliver a negligible dose (<0.05mT). Devices were also to be worn 4 hours/day for 60 days. (n=32; Mean age: 34+/-7)
Outcomes: The primary outcomes were the return of postoperative Ankle Activity Score (AAS) within 1 point of the pre-symptom AAS score, and the time to return to that benchmark. Secondary outcome measures were the time to resume work activity, the American Orthopaedic Foot and Ankle Society (AOFAS) ankle-hindfoot score, the Foot and Ankle Outcome Score (FAOS), the Euro-Qol (EQ-5D), and pain and satisfaction on numeric rating scales (NRS). Postoperative CT was used to assess the level of the subchondral bone plate (depressed, flush, or proud) and grade the degree of bone filling (good, moderate, or poor).
Methods: RCT
Time: Patients were followed-up for 1 year postoperatively.
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The authors responsible for this critical appraisal and ACE Report indicate no potential conflicts of interest relating to the content in the original publication.