Effect of Intra-articular Platelet-Rich Plasma vs Placebo Injection on Pain and Medial Tibial Cartilage Volume in Patients With Knee Osteoarthritis

医学 骨关节炎 安慰剂 物理疗法 膝关节痛 磁共振成像 富血小板血浆 最小临床重要差异 随机对照试验 内科学 外科 放射科 病理 血小板 替代医学
作者
Kim L. Bennell,Kade L. Paterson,Ben Metcalf,Vicky Duong,Jillian Eyles,Jessica Kasza,Yuanyuan Wang,Flavia Cicuttini,Rachelle Buchbinder,Andrew Forbes,Anthony Harris,Shirley P. Yu,David Connell,James Linklater,Bing H. Wang,Win Min Oo,David J. Hunter
出处
期刊:JAMA [American Medical Association]
卷期号:326 (20): 2021-2021 被引量:286
标识
DOI:10.1001/jama.2021.19415
摘要

Importance

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.

Objective

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.

Design, Setting, and Participants

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.

Interventions

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).

Main Outcomes and Measures

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.

Results

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.

Conclusions and Relevance

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.

Trial Registration

Australian New Zealand Clinical Trials Registry Identifier:ACTRN12617000853347
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