Orthopaedic Surgery, Amsterdam UMC-Location AMC, Amsterdam, The Netherlands
Amsterdam Collaboration for Health and Safety in Sports (ACHSS), AMC/VUMC IOC Research Center, Amsterdam, The Netherlands.
BMJ Open. 2019 Oct 7;9(10):e030961. doi: 10.1136/bmjopen-2019-030961.
Platelet-rich plasma (PRP) is a potentially efficacious treatment for ankle osteoarthritis (OA), but its use has not been examined in high-quality studies. Systematic reviews show that PRP injections significantly decrease pain and improve function in patients with knee OA. Ankle OA is more common than hip or knee OA in the young active population; with a prevalence of 3.4%.PRP injections in ankle OA are shown to be safe and improve quality of life over time, but no randomised controlled trial has been conducted. Our randomised controlled trial will evaluate the efficacy of PRP injections for symptom reduction and functional improvement, compared with placebo, in the treatment of ankle (talocrural) OA.
We will conduct the Platelet-Rich plasma Injection Management for Ankle OA study: a multicentre, randomised, placebo-controlled trial. One hundred patients suffering from ankle OA will be randomised into two treatment groups: PRP injection or placebo (saline) injection. Both groups will receive two injections of PRP or placebo at an interval of 6 weeks. Primary outcome is the American Orthopaedic Foot and Ankle Society score at 26 weeks. Secondary outcomes determined at several follow-up moments up to 5 years, include Ankle Osteoarthritis Score, Foot and Ankle Outcome Score, pain subscale of (0-40), Visual Analogue Scale score (0-100), Ankle Activity Score (0-10), subjective patient satisfaction Short Form Health Survey-36, Global Attainment Scaling and the EuroQol-5 dimensions-3 levels utility score. A cost-effectiveness analysis will be performed at 1 year.
The study is approved by the Medical Ethics Review Committee Amsterdam Medical Center, the Netherlands (ABR 2018-042, approved 23 July 2018) and registered in the Netherlands trial register (NTR7261). Results and new knowledge will be disseminated through the Dutch Arthritis Association (ReumaNederland), Dutch patient federation, conferences and published in a scientific peer-reviewed journal.
NTR7261.
富含血小板的血浆（PRP）是一种治疗踝关节骨关节炎（OA）的有效方法，但尚未在高质量的研究中进行检验。系统评价显示，PRP 注射可显著减轻膝关节 OA 患者的疼痛并改善其功能。在年轻活跃人群中，踝关节 OA 比髋关节或膝关节 OA 更为常见；其患病率为 3.4%。研究表明，PRP 注射治疗踝关节 OA 是安全的，并且随着时间的推移可以提高生活质量，但尚未进行随机对照试验。我们的随机对照试验将评估 PRP 注射治疗踝关节（距下）OA 时与安慰剂相比，在减轻症状和改善功能方面的疗效。
我们将开展富含血小板的血浆注射治疗踝关节 OA 研究：一项多中心、随机、安慰剂对照试验。100 名患有踝关节 OA 的患者将被随机分为两组：PRP 注射组或安慰剂（生理盐水）注射组。两组均在 6 周间隔内接受两次 PRP 或安慰剂注射。主要结局指标为 26 周时的美国矫形足踝协会评分。次要结局指标在 5 年内的多个随访时间点确定，包括踝关节骨关节炎评分、足踝结局评分、疼痛亚量表（0-40）、视觉模拟量表评分（0-100）、踝关节活动评分（0-10）、患者满意度主观量表（36 项简短健康调查简表）、总体疗效评分和欧洲五维健康量表 3 级效用评分。将在 1 年时进行成本效果分析。
该研究已获得荷兰阿姆斯特丹医学中心医学伦理审查委员会的批准（ABR 2018-042，于 2018 年 7 月 23 日批准），并在荷兰试验注册中心（NTR7261）注册。结果和新知识将通过荷兰关节炎协会（ReumaNederland）、荷兰患者联合会、会议传播，并发表在科学同行评议期刊上。
NTR7261。
