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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

基本信息

批准号：
9382843
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
项目类别：
财政年份：
2016
资助国家：
美国
起止时间：
2016-07-25 至 2019-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9382843
关键词：
Academy 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 Eligibility Determination Enrollment Ensure Equilibrium Failure Frequencies Funding Future Goals Government Grant 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&apos Offices Physiological 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 Statistical Data Interpretation Surgeon Symptoms Tendon structure Testing Thick Thinness Training United States Visit Work 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 indexing medical specialties multidisciplinary older patient operation physical therapist post-operative rehabilitation randomized trial repaired response rotator cuff tear standard of care treatment effect willingness

项目摘要

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.

项目概要/摘要为了回应审稿人的担忧，我们提出了一个经过大幅修改的应用程序。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) 标准化康复治疗； (c) 依从性和康复内容的衡量； (d) 康复我们团队的专业知识并确保手术和非手术研究人员的平衡； (e) 结果措施选择和后续持续时间； (f) 评估患者参加随机试验的意愿； (g) 样本量的合理性； (h) 统计分析。 2010 年，美国因肩部症状而接受门诊护理的人数达到 1150 万人次。肩袖眼泪是导致肩部疼痛和残疾的主要原因之一，估计有 272,148 人因流泪而流泪。 2006 年进行了门诊手术。尽管肩袖撕裂对公共健康和经济产生了巨大影响及其治疗方法，缺乏手术与非手术的头对头比较的证据治疗。迫切需要该领域的研究和精心设计的随机对照临床试验受到美国骨科医师学会等多个权威机构的重点关注 (AAOS)、医疗保健研究和质量机构 (AHRQ) 以及 Cochrane 评论。我们的多学科团队处于独特的地位，可以进行手术与手术的随机对照试验 ≥50 岁患者的非创伤性全层肩袖撕裂的非手术治疗。我们建议从六 (6) 个高容量站点进行招募，这些站点构成一个名为“the”的大型多中心联盟的一部分多中心骨科成果网络 (MOON)。利用这一基础设施，我们建议招募 400 名患有非创伤性肩袖全层撕裂的患者，并将他们随机分为手术组或非手术组手术治疗的目的是在一 (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 拨款将为我们提供所需的资金： (a) 起草操作和程序手册（MOOP）； (b) 完成研究调查问卷和表格； (三) 最终确定手术和非手术干预护理标准； (d) 安排物理治疗师转介按邮政编码的数据库； (e) 获得所有试验中心的 IRB 批准； (f) 设置并测试 REDCap 数据库安全数据存储和在线随机化； (g) 对所有现场人员进行培训，规范招聘、学习程序和数据收集，以及； (h) 设立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康复方案的同质性和依从性，并验证患者自我报告康复频率和遵守临床记录。我们将评估以下人士的意愿患者参加一项手术与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。