Zanasi Lorenzo, Boffa Angelo, De Marziani Luca, Lisignoli Gina, Belvedere Claudio, Miceli Marco, Zaffagnini Stefano, Filardo Giuseppe, Di Martino Alessandro
Clinica Ortopedica e Traumatologica II, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.
Clinica Ortopedica e Traumatologica II, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy
BMJ Open. 2024 Dec 12;14(12):e087552. doi: 10.1136/bmjopen-2024-087552.
Knee osteotomy combined with meniscal allograft transplantation (MAT) showed promising results to treat unicompartmental knee osteoarthritis (OA) secondary to meniscal deficiency and knee malalignment. However, there is still no high-level evidence to demonstrate whether the combination of these two treatments is superior to osteotomy alone.
52 patients with unicompartmental knee OA Kellgren-Lawrence grade ≤3 secondary to meniscal deficiency and knee malalignment (aged 20-60 years) are randomised to undergo knee osteotomy associated with MAT or knee osteotomy alone in a 1:1 ratio. The primary outcome is the International Knee Documentation Committee (IKDC) subjective score at 12 months. The secondary outcomes are the IKDC subjective score at 1, 3 and 6 months, the Western Ontario and McMaster Universities Osteoarthritis Index score, the Knee Injury and Osteoarthritis Outcome Score, the Visual Analogue Scale, the EuroQol Visual Analogue Scale, the Tegner Activity Level Scale, objective parameters (transpatellar circumference, suprapatellar circumference and range of motion), patient expectation on treatment efficacy and patient satisfaction at 1, 3, 6 and 12 months. Radiographs are performed at baseline and at 1-, 6- and 12-month follow-ups and magnetic resonance evaluations at baseline and at 12 months. Biomechanical assessment is performed through gait analysis before surgery and at 12 months, investigating motion data, biomechanical parameters and muscle activation through electromyography. In addition, to detect early joint environment changes and potential MAT effects in protecting the articular surface providing a better knee homeostasis, biological markers of cartilage turnover and inflammation obtained from synovial fluid, serum and urine are evaluated at baseline and at 24 hours, 1-, 3-, 6- and 12-month follow-ups.
The study protocol has been approved by Emilia Romagna's Ethics Committee (CE-AVEC), Bologna, Italy. Written informed consent is obtained from all participants. Findings of this study will be disseminated through peer-reviewed publications and conference presentations.
March 2023.
NCT05840887.
膝关节截骨术联合半月板同种异体移植（MAT）在治疗半月板缺损和膝关节力线不正继发的单髁膝关节骨关节炎（OA）方面显示出了良好的效果。然而，目前仍缺乏高级别证据来证明这两种治疗方法的联合是否优于单纯截骨术。
52例半月板缺损和膝关节力线不正继发的单髁膝关节OA（Kellgren-Lawrence分级≤3级）患者，年龄在20至60岁之间，按1:1比例随机分为接受膝关节截骨术联合MAT组或单纯膝关节截骨术组。主要结局指标是12个月时的国际膝关节文献委员会（IKDC）主观评分。次要结局指标包括1、3和6个月时的IKDC主观评分、西安大略和麦克马斯特大学骨关节炎指数评分、膝关节损伤和骨关节炎结局评分、视觉模拟量表、欧洲五维度健康量表视觉模拟量表、Tegner活动水平量表、客观参数（髌周周长、髌上周长和活动范围）、患者对治疗效果的期望以及1、3、6和12个月时的患者满意度。在基线、1、6和12个月随访时进行X线检查，在基线和12个月时进行磁共振评估。通过术前和12个月时的步态分析进行生物力学评估，通过肌电图研究运动数据、生物力学参数和肌肉激活情况。此外，为了检测早期关节环境变化以及MAT在保护关节表面、提供更好的膝关节内环境稳定方面的潜在作用，在基线、术后24小时、1、3、6和12个月随访时评估从滑液、血清和尿液中获得的软骨周转和炎症生物标志物。
本研究方案已获得意大利博洛尼亚艾米利亚-罗马涅伦理委员会（CE-AVEC）的批准。所有参与者均获得书面知情同意。本研究的结果将通过同行评审出版物和会议报告进行传播。
2023年3月。
NCT05840887。
