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

Liam D.A. Paget*, Gustaaf Reurink, Robert Jan De Vos, Adam Weir, Maarten H. Moen, Sita M.A. Bierma-Zeinstra, Sjoerd A.S. Stufkens, Gino M.M.J. Kerkhoffs, Johannes L. Tol

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

69 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)1595-1605
Number of pages11
JournalJAMA - Journal of the American Medical Association
Volume326
Issue number16
DOIs
Publication statusPublished - 26 Oct 2021

Bibliographical note

Funding Information:
conduct of the study. Dr Moen reported receiving institutional nonfinancial support from Arthrex (Hettich centrifuge on loan) during the conduct of the study. Dr Bierma-Zeinstra reported receiving or having independent research grants pending from The Netherlands Organisation for Health Research and Development, CZ, European Union, Foreum, the Dutch Arthritis Society, personal fees from Osteoarthritis Research Society International as an associate editor of Osteoarthritis and Cartilage, and consultancy fees from Pfizer outside the submitted work. Dr Stufkens reported receiving an institutional grant from the Dutch Arthritis Society and institutional nonfinancial support from Arthrex (Hettich centrifuge on loan) during the conduct of the study. Dr Kerkhoffs reported receiving an institutional grant from the Dutch Arthritis Society and nonfinancial support from Arthrex (Hettich centrifuge on loan) during the conduct of the study and grants from Arthrex for research-related payments and personal fees as an associate editor for the Knee Surgery, Sports Traumatology, Arthroscopy outside the submitted work. Dr Tol reported grants from the Dutch Arthritis Society (a Dutch nonprofit patient organization) and institutional nonfinancial support from Arthrex (Hettich centrifuge on loan) during the conduct of the study.

Publisher Copyright:
© 2021 American Medical Association. All rights reserved.

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