退行性巨大肩袖撕裂的治疗：一项随机非劣效性比较外科试验的研究方案
Treatment of degenerative massive rotator cuff tears: a study protocol for a randomized non-inferiority comparative surgical trial.
作者信息
Lädermann Alexandre, Pernoud Anthony, Cochard Blaise, Bothorel Hugo
机构信息
Division of Orthopaedics and Trauma Surgery, La Tour Hospital, Rue J.-D. Maillard 3, 1217, Meyrin, CH-1217, Switzerland.
Faculty of Medicine, University of Geneva, Rue Michel-Servet 1, Geneva 4, 1211, Switzerland.
出版信息
Trials. 2025 Aug 4;26(1):270. doi: 10.1186/s13063-025-08990-9.
BACKGROUND
Massive degenerative rotator cuff tears (MRCTs) represent a persistent challenge in shoulder surgery. While arthroscopic rotator cuff repair (ARCR) remains a widely accepted treatment with good functional outcomes, it is associated with a risk of retear and progression to cuff tear arthropathy. Reverse shoulder arthroplasty (RSA) has emerged as a viable alternative, particularly in cases where the reparability of the cuff is uncertain, offering pain relief and functional improvement. However, the optimal treatment approach for repairable MRCT in patients aged 60 to 80 years remains debated. This trial aims to assess whether RSA provides non-inferior outcomes to ARCR in patients with degenerative MRCTs, with a particular focus on function, pain, and quality of life.
METHODS
This is a prospective, randomized, controlled, non-inferiority trial. A total of 145 patients with symptomatic, repairable MRCT will be enrolled and randomized in a 1:1 ratio to undergo either ARCR or RSA. The primary outcome is the American Shoulder and Elbow Surgeons (ASES) score at 24 months postoperatively. Secondary outcomes include ASES at 6 weeks and 6 months; Visual Analog Scale (VAS) for pain; Single Assessment Numeric Evaluation (SANE); Constant score; range of motion (ROM) in flexion, extension, and internal/external rotation; repair integrity (ultrasound for ARCR, radiographs for RSA); and complication rates. PROMs will be assessed at baseline, 1.5, 6, and 24 months. All adverse events and complications will be systematically recorded.
DISCUSSION
This trial will provide robust comparative data to assess whether RSA is non-inferior to ARCR at two years postoperatively in terms of shoulder function and patient-reported outcomes in patients with repairable MRCT. The results aim to support evidence-based decision-making in clinical practice.
TRIAL REGISTRATION
The protocol was approved by the Ethics Committee Board (CCER 2023-00111) in March 2023 and by ClinicalTrial.gov (NCT05807854).
背景
巨大退行性肩袖撕裂（MRCT）是肩部手术中持续存在的挑战。虽然关节镜下肩袖修复术（ARCR）仍是一种广泛接受且功能预后良好的治疗方法，但它存在再次撕裂和发展为肩袖撕裂性关节病的风险。反向全肩关节置换术（RSA）已成为一种可行的替代方案，特别是在肩袖可修复性不确定的情况下，能缓解疼痛并改善功能。然而，60至80岁可修复性MRCT患者的最佳治疗方法仍存在争议。本试验旨在评估RSA在退行性MRCT患者中是否能提供不劣于ARCR的疗效，特别关注功能、疼痛和生活质量。
方法
这是一项前瞻性、随机、对照、非劣效性试验。总共145例有症状的、可修复的MRCT患者将被纳入，并按1:1的比例随机分组，分别接受ARCR或RSA。主要结局指标是术后24个月时的美国肩肘外科医师（ASES）评分。次要结局指标包括术后6周和6个月时的ASES评分；疼痛视觉模拟量表（VAS）；单项评估数字评定法（SANE）；Constant评分；屈伸及内/外旋转活动度（ROM）；修复完整性（ARCR用超声，RSA用X线片）；以及并发症发生率。患者报告结局量表（PROMs）将在基线、1.5、6和24个月时进行评估。所有不良事件和并发症都将被系统记录。
讨论
本试验将提供有力的比较数据，以评估在可修复性MRCT患者中，术后两年时RSA在肩部功能和患者报告结局方面是否不劣于ARCR。结果旨在支持临床实践中的循证决策。
试验注册
该方案于2023年3月获得伦理委员会（CCER 2023 - 00111）批准，并在ClinicalTrial.gov注册（NCT05807854）。
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