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Original Investigation
October 26, 2021

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

Author Affiliations
  • 1Amsterdam UMC, University of Amsterdam, Department of Orthopedic Surgery, Amsterdam Movement Sciences, Amsterdam, the Netherlands
  • 2Academic Center for Evidence-based Sports medicine (ACES), Amsterdam, the Netherlands
  • 3Amsterdam Collaboration for Health and Safety in Sports (ACHSS), AMC/VUmc IOC Research Center, Amsterdam, the Netherlands
  • 4The Sport Physician Group, Department of Sports Medicine, OLVG, Amsterdam, the Netherlands
  • 5Department of Orthopedic Surgery and Sports Medicine, Erasmus MC University Medical Center, Rotterdam, the Netherlands
  • 6Aspetar Sports Groin Pain Centre, Aspetar Orthopedic and Sports Medicine Hospital, Doha, Qatar
  • 7Sport medicine and exercise clinic Haarlem (SBK), Haarlem, the Netherlands
  • 8Department of Sports Medicine, Bergman Clinics, Naarden, the Netherlands
  • 9Department of General Practice, Erasmus University Medical Center, Rotterdam, the Netherlands
  • 10Aspetar Orthopedic and Sports Medicine Hospital, Doha, Qatar
JAMA. 2021;326(16):1595-1605. doi:10.1001/jama.2021.16602
Key Points

Question  Do intra-articular platelet-rich plasma injections improve ankle symptoms and function in patients with ankle osteoarthritis?

Findings  In this randomized clinical trial that included 100 patients, treatment with 2 intra-articular platelet-rich plasma injections vs placebo injections with saline resulted in a mean change in the American Orthopaedic Foot and Ankle Society score (range, 0-100; higher scores indicate less pain and better function) of 10 vs 11 points over 26 weeks; the between-group difference was not statistically significant.

Meaning  These findings do not support the use of platelet-rich plasma injections for patients with ankle osteoarthritis.

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

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