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- Title
Effect of Intra-articular Platelet-Rich Plasma vs Placebo Injection on Pain and Medial Tibial Cartilage Volume in Patients With Knee Osteoarthritis: The RESTORE Randomized Clinical Trial.
- Authors
Bennell, Kim L.; Paterson, Kade L.; Metcalf, Ben R.; Duong, Vicky; Eyles, Jillian; Kasza, Jessica; Wang, Yuanyuan; Cicuttini, Flavia; Buchbinder, Rachelle; Forbes, Andrew; Harris, Anthony; Yu, Shirley P.; Connell, David; Linklater, James; Wang, Bing Hui; Oo, Win Min; Hunter, David J.
- Abstract
<bold>Importance: </bold>Most clinical guidelines do not recommend platelet-rich plasma (PRP) for knee osteoarthritis (OA) because of lack of high-quality evidence on efficacy for symptoms and joint structure, but the guidelines emphasize the need for rigorous studies. Despite this, use of PRP in knee OA is increasing.<bold>Objective: </bold>To evaluate the effects of intra-articular PRP injections on symptoms and joint structure in patients with symptomatic mild to moderate radiographic medial knee OA.<bold>Design, Setting, and Participants: </bold>This randomized, 2-group, placebo-controlled, participant-, injector-, and assessor-blinded clinical trial enrolled community-based participants (n = 288) aged 50 years or older with symptomatic medial knee OA (Kellgren and Lawrence grade 2 or 3) in Sydney and Melbourne, Australia, from August 24, 2017, to July 5, 2019. The 12-month follow-up was completed on July 22, 2020.<bold>Interventions: </bold>Interventions involved 3 intra-articular injections at weekly intervals of either leukocyte-poor PRP using a commercially available product (n = 144 participants) or saline placebo (n = 144 participants).<bold>Main Outcomes and Measures: </bold>The 2 primary outcomes were 12-month change in overall average knee pain scores (11-point scale; range, 0-10, with higher scores indicating worse pain; minimum clinically important difference of 1.8) and percentage change in medial tibial cartilage volume as assessed by magnetic resonance imaging (MRI). Thirty-one secondary outcomes (25 symptom related and 6 MRI assessed; minimum clinically important difference not known) evaluated pain, function, quality of life, global change, and joint structures at 2-month and/or 12-month follow-up.<bold>Results: </bold>Among 288 patients who were randomized (mean age, 61.9 [SD, 6.5] years; 169 [59%] women), 269 (93%) completed the trial. In both groups, 140 participants (97%) received all 3 injections. After 12 months, treatment with PRP vs placebo injection resulted in a mean change in knee pain scores of -2.1 vs -1.8 points, respectively (difference, -0.4 [95% CI, -0.9 to 0.2] points; P = .17). The mean change in medial tibial cartilage volume was -1.4% vs -1.2%, respectively (difference, -0.2% [95% CI, -1.9% to 1.5%]; P = .81). Of 31 prespecified secondary outcomes, 29 showed no significant between-group differences.<bold>Conclusions and Relevance: </bold>Among patients with symptomatic mild to moderate radiographic knee OA, intra-articular injection of PRP, compared with injection of saline placebo, did not result in a significant difference in symptoms or joint structure at 12 months. These findings do not support use of PRP for the management of knee OA.<bold>Trial Registration: </bold>Australian New Zealand Clinical Trials Registry Identifier: ACTRN12617000853347.
- Subjects
OSTEOARTHRITIS treatment; PAIN management; PLATELET-rich plasma; KNEE diseases; RESEARCH; PAIN measurement; PAIN; RESEARCH methodology; MEDICAL cooperation; EVALUATION research; TREATMENT failure; COMPARATIVE studies; RANDOMIZED controlled trials; OSTEOARTHRITIS; INTRA-articular injections; ARTICULAR cartilage; KNEE; DISEASE complications
- Publication
JAMA: Journal of the American Medical Association, 2021, Vol 326, Issue 20, p2021
- ISSN
0098-7484
- Publication type
Article
- DOI
10.1001/jama.2021.19415