Operative versus Non-Operative Treatments for Atraumatic Rotator Cuff Tears: A Mutlicenter Randomized Controlled Trial

项目总结/摘要 我们提出了一个重大修改的应用程序，以回应我们的审查员的关注。主要问题是， 涉及的内容包括：（a）完成规划活动的描述和步骤;（B） 康复治疗;（c）测量康复的依从性和内容;（d）康复 我们团队的专业知识，并确保手术和非手术研究者的平衡;（e）结果指标 选择和随访持续时间;（f）评估患者参与随机试验的意愿; (g)样本量合理性说明;（h）统计分析。 2010年，美国有1150万例肩关节症状门诊就诊。肩袖 眼泪是肩痛和残疾的主要原因之一，估计占272148 2006年的门诊手术尽管肩袖撕裂对公众健康和经济造成了重大影响， 和他们的治疗，缺乏证据的头对头比较手术与非手术 治疗迫切需要在这一领域进行研究，并设计一个良好的随机对照临床试验， 包括美国矫形外科学会在内的多个权威机构强调， （AAOS）、医疗保健研究和质量机构（AHRQ）以及科克伦综述中。 我们的多学科团队处于一个独特的位置，可以进行一项随机对照试验， 年龄≥50岁患者非创伤性全层肩袖撕裂的非手术治疗。我们 建议从六（6）个高容量研究中心招募，这些研究中心构成大型多中心联盟的一部分，称为 多中心骨科结局网络（MOON）。利用这一基础设施，我们建议招聘400名 非创伤性全层肩袖撕裂患者，并将其随机分为手术组或非手术组。 手术治疗，目的是在1年随访时比较这两组的疼痛和功能。 我们还将研究肩袖撕裂大小和患者年龄对效果的影响。 在进行如此大规模的随机试验之前，U34赠款将为我们提供所需的资金： (a)起草业务和程序手册;（B）最后确定研究问卷和表格;（c） 最后确定手术和非手术干预护理标准;（d）建立理疗师转诊制度 数据库;（e）从所有试验中心获得IRB批准;（f）建立并测试REDCap数据库， 安全的数据存储和在线随机化;（g）培训所有研究中心工作人员，使招募、研究 （h）设立一个数据和安全监测委员会。在U34期间，我们将 进行试点研究，以评估同质性和康复方案的依从性，并验证患者 自我报告的康复频率和遵守临床记录。我们将评估 患者参加一项随机试验，比较手术与非手术治疗肩袖撕裂。 因此，U34对于完成后续随机临床试验至关重要。

Project Summary/Abstract We present a substantially revised application in response to our reviewers' concerns. Major issues that were addressed include: (a) description and steps to accomplish planning activities; (b) standardization of rehabilitation treatments; (c) measurement of compliance and content of rehabilitation; (d) rehabilitation expertise of our team and ensuring a balance of surgical and non-surgical investigators; (e) outcome measures selection and follow-up duration; (f) assessment of willingness of patients to participate in a randomized trial; (g) sample size justification, and; (h) statistical analyses. Shoulder symptoms accounted for 11.5 million ambulatory care visits in 2010 in the United States. Rotator cuff tears are one of the leading causes of shoulder pain and disability, and accounted for an estimated 272,148 ambulatory surgeries in 2006. Despite the substantial public health and economic impact of rotator cuff tears and their treatments, there is lack of evidence on a head-to-head comparison of surgery versus non-operative treatment. The urgent need for research in this area and a well-designed randomized controlled clinical trial is highlighted by multiple authoritative agencies including the American Academy of Orthopaedic Surgeons (AAOS), Agency for Healthcare Research and Quality (AHRQ), and in Cochrane reviews. Our multi-disciplinary team is in a unique position to conduct a randomized controlled trial of operative versus non-operative treatments for atraumatic full-thickness rotator cuff tears in patients' ≥50 years of age. We propose recruitment from six (6) high volume sites that form part of a large multi-center consortium called the Multicenter Orthopaedic Outcomes Network (MOON). Using this infrastructure, we propose to recruit 400 patients with atraumatic full-thickness rotator cuff tears and randomize them to either operative or non- operative treatments with the goal to compare pain and function in these two groups at one (1) year follow-up. We will also study effect modification by rotator cuff tear size and patient age. Prior to conducting such a large scale randomized trial, the U34 grant would provide us the needed funding to: (a) Draft a manual of operations and procedures (MOOP); (b) Finalize study questionnaires and forms; (c) Finalize operative and non-operative intervention standards of care; (d) Set up physical therapist referral database by zip code; (e) Obtain IRB approval from all trial sites; (f) Set up and test REDCap database for secure data storage and online randomization; (g) Train all site personnel to standardize recruitment, study procedures, and data collection, and; (h) Set up a data and safety monitoring board. During the U34, we will perform a pilot study to assess homogeneity and compliance with rehabilitation protocols, and validate patient self-report of rehabilitation frequency and compliance with clinical records. We will assess willingness of patients to participate in a randomized trial of operative versus non-operative treatment for rotator cuff tears. Thus, the U34 is critical to accomplish the subsequent randomized clinical trial.