Amsterdam UMC, University of Amsterdam, Department of Orthopedic Surgery, Amsterdam Movement Sciences, Amsterdam, the Netherlands.
Academic Center for Evidence-based Sports medicine (ACES), Amsterdam, the Netherlands.
JAMA. 2021 Oct 26;326(16):1595-1605. doi: 10.1001/jama.2021.16602.
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.
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.
Patients were randomly assigned (1:1) to receive 2 ultrasonography-guided intra-articular injections of either PRP (n = 48) or placebo (saline; n = 52).
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.
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.
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.
Netherlands Trial Register: NTR7261.
大约有 3.4%的成年人患有踝（距下）骨关节炎，在年轻患者中，踝骨关节炎比膝骨关节炎和髋骨关节炎更为常见。目前几乎没有有效的非手术干预措施，但富血小板血浆（PRP）注射被广泛应用，并且有一些证据表明其对膝骨关节炎有效。
确定 PRP 注射治疗踝骨关节炎患者症状和功能的效果。
设计、地点和参与者：这是一项在荷兰 6 个地点进行的多中心、分组随机、双盲、安慰剂对照的临床试验，共纳入了 100 名疼痛评分大于 40（评分范围 0-100）且距下关节间隙变窄的患者。招募工作于 2018 年 8 月 24 日开始，2020 年 12 月 3 日完成随访。
患者被随机（1:1）分配接受 2 次超声引导下关节内注射 PRP（n=48）或安慰剂（生理盐水；n=52）。
主要结局是 26 周时经过验证的美国矫形足踝协会评分（评分范围 0-100；评分越高表示疼痛越少、功能越好；最小临床重要差异为 12 分）。
在 100 名随机患者（平均年龄 56 岁；45[45%]名女性）中，没有患者因主要结局而失访。与基线值相比，PRP 组的美国矫形足踝协会评分平均提高 10 分（从 63 分提高至 73 分[95%CI，6-14]；P<.001），安慰剂组提高 11 分（从 64 分提高至 75 分[95%CI，7-15]；P<.001）。26 周时两组间的调整后差异为-1（[95%CI，-6 至 3]；P=0.56）。安慰剂组报告了 1 例严重不良事件，但与干预无关；PRP 组有 13 例其他不良事件，安慰剂组有 8 例。
在踝骨关节炎患者中，与安慰剂注射相比，关节内注射 PRP 并未在 26 周内显著改善踝部症状和功能。本研究结果不支持 PRP 注射用于踝骨关节炎。
荷兰临床试验注册库：NTR7261。
