Efficacy of intra-articular injection of combined platelet-rich-plasma (PRP) and hyaluronic acid (HA) in knee degenerative joint disease: a prospective, randomized, double-blind clinical trial.
Chiara Fossati, Filippo M N Randelli, Fabio Sciancalepore, Daniela Maglione, Stefano Pasqualotto, Federico Ambrogi, Alessandra Menon
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引用次数: 0
Abstract
Purpose: Intra-articular injections of hyaluronic acid (HA) and platelet-rich plasma (PRP) represent promising options in the conservative treatment of early stages of knee osteoarthritis (OA). Although the combined use of these two compounds seems to have a synergistic effect in pre-clinical studies, few clinical trials compared the association of PRP and HA with PRP and HA alone. The aim of study is to evaluate the efficacy of combined intra-articular injections of PRP and HA in the treatment of mild to moderate knee OA, compared to PRP and HA alone.
Methods: One hundred and seventy-four patients were prospectively enrolled and randomized to undergo three intra-articular injections of either HA or PRP or the combination of PRP and HA with a two-week interval period. Patients were evaluated before treatment and after 3, 6, and 12 months using Western Ontario and McMaster Universities Osteoarthritis (WOMAC) score, Knee Injury and Osteoarthritis Outcome Score, International Knee Documentation Committee subjective score, Visual Analogue Scale and TEGNER Activity Scores.
Results: All the treatments proved to be effective in reducing pain and improving joint function. The analysis of covariance did not show statistically significant differences among the three groups for any of the investigated outcome parameters after 6 and 12 months (WOMAC: p = 0.45 and p = 0.64, respectively). No significant differences were found in terms of adverse events (p = 0.49) and painkiller use (p = 0.28 and p = 0.56, respectively) among the three groups.
Conclusion: This multicenter, prospective, randomized, double-blind controlled trial revealed that intra-articular injections of PRP + HA, PRP, or HA represent a safe and viable treatment with comparable efficacy in terms of pain relief and functional outcomes in mild to moderate knee OA.
目的:透明质酸(HA)和富血小板血浆(PRP)的关节内注射是膝关节骨性关节炎(OA)早期保守治疗中很有前景的选择。虽然这两种化合物的联合使用在临床前研究中似乎具有协同作用,但很少有临床试验对 PRP 和 HA 的联合使用与 PRP 和 HA 的单独使用进行比较。本研究旨在评估联合关节内注射 PRP 和 HA 与单独注射 PRP 和 HA 相比,在治疗轻度至中度膝关节 OA 中的疗效:174 名患者接受了前瞻性登记,并随机接受了三次 HA 或 PRP 或 PRP 与 HA 联合疗法的关节内注射,每次间隔两周。使用西安大略和麦克马斯特大学骨关节炎(WOMAC)评分、膝关节损伤和骨关节炎结果评分、国际膝关节文献委员会主观评分、视觉模拟量表和 TEGNER 活动评分对患者进行治疗前和治疗 3、6、12 个月后的评估:所有治疗方法均能有效减轻疼痛并改善关节功能。协方差分析表明,6 个月和 12 个月后,三组之间的任何研究结果参数均无显著统计学差异(WOMAC:分别为 p = 0.45 和 p = 0.64)。在不良事件(p = 0.49)和止痛药使用(分别为 p = 0.28 和 p = 0.56)方面,三组之间没有发现明显差异:这项多中心、前瞻性、随机、双盲对照试验表明,关节内注射 PRP + HA、PRP 或 HA 是一种安全可行的治疗方法,对轻度至中度膝关节 OA 患者的疼痛缓解和功能改善效果相当。
期刊介绍:
"Archives of Orthopaedic and Trauma Surgery" is a rich source of instruction and information for physicians in clinical practice and research in the extensive field of orthopaedics and traumatology. The journal publishes papers that deal with diseases and injuries of the musculoskeletal system from all fields and aspects of medicine. The journal is particularly interested in papers that satisfy the information needs of orthopaedic clinicians and practitioners. The journal places special emphasis on clinical relevance.
"Archives of Orthopaedic and Trauma Surgery" is the official journal of the German Speaking Arthroscopy Association (AGA).