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

非手术性肩袖撕裂的手术治疗与非手术治疗：多中心随机对照试验

• 批准号: 9173286
• 负责人: Nitin B Jain
• 金额: $ 19.75万
• 依托单位: VANDERBILT UNIVERSITY MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-07-25 至 2018-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9173286
• 关键词: Academy; Accounting; Address; Affect; Age; Age-Years; Ambulatory Care; Ambulatory Surgical Procedures; American; Area; Caring; Case Series; Clinic; Clinical; Clinical Trials Data Monitoring Committees; Code; Conduct Clinical Trials; Data; Data Collection; Data Storage and Retrieval; Databases; Decision Making; Enrollment; Ensure; Equilibrium; Failure; Frequencies; Funding; Future; Goals; Government; Grant; Healed; Health Care Research; Healthcare Systems; Heterogeneity; Human Resources; Individual; Institutional Review Boards; Intervention; Investigation; Literature; Magnetic Resonance Imaging; Manuals; Measurement; Measures; Medicine; Modification; Muscle; Musculoskeletal; Operative Surgical Procedures; Orthopedics; Outcome; Outcome Measure; Pain; Patient Self-Report; Patients; Phase; Physicians' Offices; Pilot Projects; Positioning Attribute; Procedures; Protocols documentation; Public Health; Quality of life; Questionnaires; Randomized; Randomized Clinical Trials; Randomized Controlled Clinical Trials; Randomized Controlled Trials; Records; Recruitment Activity; Rehabilitation therapy; Reporting; Research; Research Infrastructure; Research Personnel; Research Priority; Rotator Cuff; Sample Size; Secure; Shoulder; Shoulder Pain; Site; Societies; Standardization; Surgeon; Symptoms; Tendon structure; Testing; Thick; Training; United States; Visit; Work; abstracting; aging population; base; bone; clinical practice; comparative; cost; design; disability; economic impact; evidence base; experience; follow-up; functional improvement; head-to-head comparison; healing; health care quality; health economics; indexing; medical specialties; older patient; operation; physical therapist; post-operative rehabilitation; randomized trial; repaired; response; rotator cuff tear; standard of care; treatment effect; willingness

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.

项目摘要/摘要 我们提交了一份经过大幅修改的申请，以回应我们评审员的关切。主要问题是 讨论内容包括：(A)完成规划活动的说明和步骤；(B)标准化 康复治疗；(C)衡量依从性和康复内容；(D)康复 我们团队的专业知识，并确保外科和非外科调查人员的平衡；(E)成果衡量 选择和随访时间；(F)评估患者参与随机试验的意愿； (G)样本量理由；和(H)统计分析。 2010年，肩部症状在美国门诊就诊人数为1150万人次。肩袖 泪水是导致肩部疼痛和残疾的主要原因之一，估计有272,148人流泪 2006年进行了门诊手术。尽管肩袖撕裂对公共健康和经济造成了巨大的影响 以及他们的治疗方法，缺乏手术和非手术的面对面比较的证据 治疗。这方面的研究和精心设计的随机对照临床试验的迫切需要是 由包括美国矫形外科医生学会在内的多个权威机构重点介绍 (AAOS)，医疗研究和质量机构(AHRQ)，以及在Cochrane评论中。 我们的多学科团队处于独特的地位，可以进行手术和治疗的随机对照试验 50岁≥患者无创性全层肩袖撕裂的非手术治疗我们 建议从六(6)个高流量站点进行招聘，这些站点是大型多中心财团的一部分，称为 多中心矫形外科结果网络(MOUNE)。利用这一基础设施，我们计划招聘400人 无创性全层肩袖撕裂的患者随机分为手术组和非手术组 手术治疗的目的是在一(1)年的随访中比较这两组患者的疼痛和功能。 我们还将研究肩袖撕裂大小和患者年龄对疗效的影响。 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，以： (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)建立物理治疗师转介 按邮政编码建立数据库；(E)获得所有试验地点的内部审查机构批准；(F)建立和测试红帽数据库，以 安全的数据存储和在线随机化；(G)培训所有现场人员，使招聘、研究标准化 (H)设立数据和安全监测委员会。在U34期间，我们将 执行试点研究以评估同质性和遵守康复方案，并验证患者 自我报告康复频率和临床记录的依从性。我们将评估是否愿意 患者参加一项手术和非手术治疗肩袖撕裂的随机试验。 因此，U34对于完成后续的随机临床试验至关重要。