Audigé Laurent, Bucher Heiner C C, Aghlmandi Soheila, Stojanov Thomas, Schwappach David, Hunziker Sabina, Candrian Christian, Cunningham Gregory, Durchholz Holger, Eid Karim, Flury Matthias, Jost Bernhard, Lädermann Alexandre, Moor Beat Kaspar, Moroder Philipp, Rosso Claudio, Schär Michael, Scheibel Markus, Spormann Christophe, Suter Thomas, Wieser Karl, Zumstein Matthias, Müller Andreas M
Research and Development, Schulthess Klinik, Zurich, Switzerland
Orthopaedic Surgery and Traumatology, University Hospital Basel, Basel, Switzerland.
BMJ Open. 2021 Apr 22;11(4):e045702. doi: 10.1136/bmjopen-2020-045702.
In the field of arthroscopic rotator cuff repair (ARCR), reporting standards of published studies differ dramatically, notably concerning adverse events (AEs). In addition, prognostic studies are overall methodologically poor, based on small data sets and explore only limited numbers of influencing factors. We aim to develop prognostic models for individual ARCR patients, primarily for the patient-reported assessment of shoulder function (Oxford Shoulder Score (OSS)) and the occurrence of shoulder stiffness 6 months after surgery. We also aim to evaluate the use of a consensus core event set (CES) for AEs and validate a severity classification for these events, considering the patient's perspective.
A cohort of 970 primary ARCR patients will be prospectively documented from several Swiss and German orthopaedic clinics up to 24 months postoperatively. Patient clinical examinations at 6 and 12 months will include shoulder range of motion and strength (Constant Score). Tendon repair integrity status will be assessed by ultrasound at 12 months. Patient-reported questionnaires at 6, 12 and 24 months will determine functional scores (subjective shoulder value, OSS), anxiety and depression scores, working status, sports activities, and quality of life (European Quality of Life 5 Dimensions 5 Level questionnaire). AEs will be documented according to a CES. Prognostic models will be developed using an internationally supported regression methodology. Multiple prognostic factors, including patient baseline demographics, psychological, socioeconomic and clinical factors, rotator cuff integrity, concomitant local findings, and (post)operative management factors, will be investigated.
This project contributes to the development of personalised risk predictions for supporting the surgical decision process in ARCR. The consensus CES may become an international reference for the reporting of complications in clinical studies and registries. Ethical approval was obtained on 1 April 2020 from the lead ethics committee (EKNZ, Basel, Switzerland; ID: 2019-02076). All participants will provide informed written consent before enrolment in the study.
NCT04321005.
Version 2 (13 December 2019).
在关节镜下肩袖修复（ARCR）领域，已发表研究的报告标准差异巨大，尤其是在不良事件（AE）方面。此外，预后研究总体上方法学质量较差，基于小数据集且仅探索了有限数量的影响因素。我们旨在为个体ARCR患者开发预后模型，主要用于患者报告的肩部功能评估（牛津肩部评分（OSS））以及术后6个月肩部僵硬的发生情况。我们还旨在评估使用不良事件共识核心事件集（CES）并验证这些事件的严重程度分类，同时考虑患者的观点。
将从瑞士和德国的多家骨科诊所前瞻性记录970例初次ARCR患者，直至术后24个月。术后6个月和12个月的患者临床检查将包括肩部活动范围和力量（Constant评分）。术后12个月通过超声评估肌腱修复完整性状态。术后6个月、12个月和24个月的患者报告问卷将确定功能评分（主观肩部价值、OSS）、焦虑和抑郁评分、工作状态、体育活动以及生活质量（欧洲生活质量5维度5水平问卷）。不良事件将根据CES进行记录。将使用国际支持的回归方法开发预后模型。将研究多个预后因素，包括患者基线人口统计学、心理、社会经济和临床因素、肩袖完整性、伴随的局部发现以及（术）后管理因素。
该项目有助于开发个性化风险预测，以支持ARCR的手术决策过程。共识CES可能成为临床研究和注册中并发症报告的国际参考。2020年4月1日获得了牵头伦理委员会（瑞士巴塞尔EKNZ；ID：2019 - 02076）的伦理批准。所有参与者在纳入研究前将提供知情书面同意。
NCT04321005。
版本号2（2019年12月13日）。
