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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
Bennell KL, Paterson KL, Metcalf BR, Duong V, Eyles J, Kasza J, Wang Y, Cicuttini F, Buchbinder R, Forbes A, et al
Jama. 2021;326(20):2021-2030
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Abstract
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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Efficacy of platelet-rich plasma injections for treating Achilles tendonitis : Systematic review of high-quality randomized controlled trials
Wang Y, Han C, Hao J, Ren Y, Wang J
Der Orthopade. 2019
Abstract
BACKGROUND The Achilles tendon is the coarsest tendon in the body. Achilles tendonitis is relatively common and its incidence is increasing. PURPOSE To evaluate the efficacy of platelet-rich plasma (PRP) injections for treating Achilles tendonitis. METHODS A literature search was carried out in the Cochrane Library Central Register of Controlled Trials (2017), PubMed (January 1976-March 2017) and EMBASE (January 1976-March 2017) databases to retrieve the available clinical evidence for PRP in the treatment of Achilles tendon lesions for a systematic review. The inclusion criteria were (1) conservative PRP treatment of Achilles tendon inflammation in a randomized controlled trial (RCT), (2) level I clinical research evidence and (3) published in English. The exclusion criteria were (1) unclear experimental methods and data and (2) PRP treatment of other diseases. RESULTS A total of 4 articles involving 152 cases were included in the analysis. The mean age of subjects was 49 years. Data on the Victorian Institute of Sport Assessment-Achilles (VISA-A) score, color Doppler ultrasound index and recovery time to normal exercise were extracted. There were no significant differences between the treatment groups and control groups following the PRP injections. CONCLUSION The lack of differences between data from the control group and the patient groups included in the studies may be related to the difficulty of performing a randomized controlled trial (RCT). A strong basis for using PRP to treat Achilles tendonitis was not found, although PRP has important clinical significance for treating Achilles tendonitis.