Departamento de Ortopedia, Grupo de Ombro e Cotovelo do Hospital Alvorada Moema, Sao Paulo, Sao Paulo, Brazil
Programa Locomotor, Hospital Israelita Albert Einstein, Sao Paulo, Brazil.
BMJ Open. 2020 Dec 28;10(12):e043126. doi: 10.1136/bmjopen-2020-043126.
Rotator cuff injuries account for up to 70% of pain in the shoulder. However, there remains no consensus on the best surgical treatment for patients with rotator cuff injuries, in terms of the cost-effectiveness and cost-utility of open and arthroscopic methods for rotator cuff repair. The objective of this trial is to compare the efficacy, cost-effectiveness and cost-utility of open and arthroscopic procedures for rotator cuff repair.
The trial is a two-group, parallel-design, randomised controlled trial. A total of 100 patients with symptomatic rotator cuff lesions will be allocated in either open or arthroscopic technique in a 1:1 ratio, considering smoking (yes or no), lesion size (≤3 cm or >3 cm) and diabetes (present or absent) as stratification factors. All patients will be included in the same rehabilitation programme after the intervention. The primary outcome measure will be the Constant-Murley Score and the EuroQol-5D-3L score at 48 weeks postsurgery. Secondary outcomes include cost-effectiveness, cost-utility, pain, complications and clinical analysis, using the Simple Shoulder Test, Visual Analogue Pain Scale (VAS), integrity of the repair evaluated through MRI, and complications and failures of the proposed methods. For the cost-effectiveness analysis, we will use the VAS and the Constant-Murley Score as measures of effectiveness. For the cost-utility analysis, we will use the EuroQol-5D-3L as a measure of utility in terms of incremental cost per quality-adjusted life-years.
The study has been approved by the local research ethics committee of both institutions: Hospital Israelita Albert Einstein and Hospital Alvorada Moema/Hospital Pró-Cardíaco. The results will be published in a peer-reviewed, open access journal.
NCT04146987.
肩袖损伤占肩部疼痛的 70%。然而，在肩袖损伤的手术治疗方面，对于开放和关节镜方法修复肩袖的成本效益和成本效用，尚未达成共识。本试验旨在比较开放和关节镜方法修复肩袖的疗效、成本效益和成本效用。
该试验为两组成平行设计的随机对照试验。共纳入 100 例有症状肩袖病变患者，按开放或关节镜技术分为 1:1 组，考虑吸烟（是或否）、病变大小（≤3cm 或>3cm）和糖尿病（存在或不存在）作为分层因素。所有患者将在干预后纳入相同的康复计划。主要观察指标为术后 48 周时的 Constant-Murley 评分和 EuroQol-5D-3L 评分。次要观察指标包括成本效益、成本效用、疼痛、并发症和临床分析，使用简单肩测试、视觉模拟疼痛量表（VAS）、MRI 评估修复的完整性以及所提出方法的并发症和失败。对于成本效益分析，我们将使用 VAS 和 Constant-Murley 评分作为有效性指标。对于成本效用分析，我们将使用 EuroQol-5D-3L 作为每质量调整生命年增量成本的效用指标。
该研究已获得两家机构的当地研究伦理委员会的批准：爱因斯坦以色列医院和莫梅亚阿尔沃拉达医院/普罗斯卡尔迪奥心脏医院。研究结果将发表在同行评议的开放获取期刊上。
NCT04146987。
