Department of Rheumatology, Henri Mondor Hospital Rheumatology Service, Creteil, France
Department of Public Health, AP-HP, Henri Mondor Hospital, Creteil, France.
BMJ Open. 2024 Nov 29;14(11):e085025. doi: 10.1136/bmjopen-2024-085025.
Despite their exponential use, intra-articular (IA) injections of platelet-rich plasma (PRP) are not part of the recommended treatments for knee osteoarthritis (OA) by most international scientific societies. The most recent clinical trials have shown conflicting results, and some did not find any clinical benefit of PRP injections. The PRP In Knee OsteoArthritis (PIKOA) trial was designed to assess the clinical efficacy and structural benefit of IA injections of PRP vs saline solution (placebo) in symptomatic knee OA.
PIKOA is an academic phase 3, superiority, triple-blind (patients, investigators and injectors), multicentre, randomised placebo-controlled trial (1:1 ratio). It compares the efficacy of 1 weekly IA injection of 5 mL PRP or placebo (saline solution) for 3 weeks with a 6-month follow-up. The trial will enrol 210 participants ≥40 years old with symptomatic and moderate radiographic knee OA (Kellgren and Lawrence grade 2 or 3). PRP is prepared with the A-CP-Kit-T (20 mL) kit and its cellular composition is characterised for each patient. The main objective is to compare change in pain on a 0 mm to 100 mm visual analogue scale (VAS) between W0 and W14. The secondary objectives are to compare the two groups in terms of decrease in VAS pain, Western Ontario and McMaster Universities Osteoarthritis Index total score and subscores, analgesics consumption, OMERACT-Osteoarthritis Research Society International responder rate and improvement in quality of life measured by the EQ-5D-5L score. All these criteria are assessed at W8, W14 and W26. The decrease in serum Coll2-1 and Coll2-1 NO₂ levels (catabolic markers, reflecting cartilage destruction or joint inflammation) and increase in N-propeptide of cartilage IIA level (reflecting cartilage formation) are assessed at W8 and W14. Adverse events and study withdrawals are collected during the study.
Ethics approval was obtained from the Nord Ouest ethical committee (2021-A00742-39). All participants need to provide written informed consent. The findings will be published in peer-reviewed journals.
NCT05378815 (ClinicalTrials.gov); pre-results.Protocol version and number: V.3 of 17 July 2023.
尽管关节内（IA）注射富含血小板的血浆（PRP）的使用呈指数增长，但大多数国际科学协会并不将其作为治疗膝关节骨关节炎（OA）的推荐治疗方法。最近的临床试验结果相互矛盾，有些甚至没有发现 PRP 注射的任何临床益处。PRP 在膝关节骨关节炎中的作用（PIKOA）试验旨在评估 IA 注射 PRP 与生理盐水（安慰剂）相比在有症状的膝关节 OA 中的临床疗效和结构获益。
PIKOA 是一项学术性 3 期、优效性、三盲（患者、研究者和注射者）、多中心、随机安慰剂对照试验（1:1 比例）。它比较了每周 1 次 IA 注射 5ml PRP 或安慰剂（生理盐水）3 周与 6 个月随访的疗效。该试验将招募 210 名年龄≥40 岁、有症状且影像学中度膝关节 OA（Kellgren 和 Lawrence 分级 2 或 3）的患者。PRP 是用 A-CP-Kit-T（20ml）试剂盒制备的，其细胞组成对每个患者进行了特征描述。主要目的是比较 W0 和 W14 时 0mm 至 100mm 视觉模拟量表（VAS）疼痛变化。次要目标是比较两组 VAS 疼痛、西安大略和麦克马斯特大学骨关节炎指数总分和子分、镇痛药消耗、OMERACT-骨关节炎研究协会国际反应率以及通过 EQ-5D-5L 评分衡量的生活质量改善情况。所有这些标准均在 W8、W14 和 W26 时进行评估。W8 和 W14 时还评估了血清 Coll2-1 和 Coll2-1NO₂水平（反映软骨破坏或关节炎症的分解代谢标志物）的降低以及软骨 IIA 型 N 端肽水平（反映软骨形成）的增加。在研究期间收集不良事件和研究退出情况。
该研究获得了 Nord Ouest 伦理委员会（2021-A00742-39）的批准。所有参与者都需要提供书面知情同意。研究结果将发表在同行评议的期刊上。
NCT05378815（ClinicalTrials.gov）；预结果。方案版本和编号：2023 年 7 月 17 日第 3 版。
