Effect of Platelet-Rich Plasma Injections vs Placebo on Ankle Symptoms and Function in Patients With Ankle Osteoarthritis: A Randomized Clinical Trial

Amsterdam UMC, University of Amsterdam, Department of Orthopedic Surgery, Amsterdam Movement Sciences, Amsterdam, the Netherlands. Academic Center for Evidence-based Sports medicine (ACES), Amsterdam, the Netherlands. Amsterdam Collaboration for Health and Safety in Sports (ACHSS), AMC/VUmc IOC Research Center, Amsterdam, the Netherlands. The Sport Physician Group, Department of Sports Medicine, OLVG, Amsterdam, the Netherlands. Department of Orthopedic Surgery and Sports Medicine, Erasmus MC University Medical Center, Rotterdam, the Netherlands. Aspetar Sports Groin Pain Centre, Aspetar Orthopedic and Sports Medicine Hospital, Doha, Qatar. Sport medicine and exercise clinic Haarlem (SBK), Haarlem, the Netherlands. Department of Sports Medicine, Bergman Clinics, Naarden, the Netherlands. Department of General Practice, Erasmus University Medical Center, Rotterdam, the Netherlands. Aspetar Orthopedic and Sports Medicine Hospital, Doha, Qatar.

Jama. 2021;326(16):1595-1605
Abstract
IMPORTANCE Approximately 3.4% of adults have ankle (tibiotalar) osteoarthritis and, among younger patients, ankle osteoarthritis is more common than knee and hip osteoarthritis. Few effective nonsurgical interventions exist, but platelet-rich plasma (PRP) injections are widely used, with some evidence of efficacy in knee osteoarthritis. OBJECTIVE To determine the effect of PRP injections on symptoms and function in patients with ankle osteoarthritis. DESIGN, SETTING, AND PARTICIPANTS A multicenter, block-randomized, double-blinded, placebo-controlled clinical trial performed at 6 sites in the Netherlands that included 100 patients with pain greater than 40 on a visual analog scale (range, 0-100) and tibiotalar joint space narrowing. Enrollment began on August 24, 2018, and follow-up was completed on December 3, 2020. INTERVENTIONS Patients were randomly assigned (1:1) to receive 2 ultrasonography-guided intra-articular injections of either PRP (n = 48) or placebo (saline; n = 52). MAIN OUTCOMES AND MEASURES The primary outcome was the validated American Orthopaedic Foot and Ankle Society score (range, 0-100; higher scores indicate less pain and better function; minimal clinically important difference, 12 points) over 26 weeks. RESULTS Among 100 randomized patients (mean age, 56 years; 45 [45%] women), no patients were lost to follow-up for the primary outcome. Compared with baseline values, the mean American Orthopaedic Foot and Ankle Society score improved by 10 points in the PRP group (from 63 to 73 points [95% CI, 6-14]; P < .001) and 11 points in the placebo group (from 64 to 75 points [95% CI, 7-15]; P < .001). The adjusted between-group difference over 26 weeks was -1 ([95% CI, -6 to 3]; P = .56). One serious adverse event was reported in the placebo group, which was unrelated to the intervention; there were 13 other adverse events in the PRP group and 8 in the placebo group. CONCLUSIONS AND RELEVANCE Among patients with ankle osteoarthritis, intra-articular PRP injections, compared with placebo injections, did not significantly improve ankle symptoms and function over 26 weeks. The results of this study do not support the use of PRP injections for ankle osteoarthritis. TRIAL REGISTRATION Netherlands Trial Register: NTR7261.
Study details
Language : eng
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