Improving Orthopedic Outcomes Through a National TJR Registry

描述（由申请人提供）：每年，超过70万美国成年人选择全关节置换（TJR）手术，以恢复身体功能，消除晚期膝关节或髋关节关节炎的疼痛，尽管进行了全面的医学治疗，但这种疼痛仍然存在。尽管广泛使用，但在手术实践和结果中仍然存在很大的差异。此外，缺乏比较有效的数据来指导外科医生和患者在最佳植入时间、手术入路、植入物选择和围手术期管理方面的决策，以防止不良后遗症和翻修。因此，国家骨科结果登记（NOOR）和队列研究将建立一个国家登记，包括来自全国所有地区和不同医院和外科医生实践环境的130名骨科医生的33,000多名不同患者。因此，该注册表的设计反映了典型的美国临床实践，而不是专注于高容量的学术中心。数据将包括基线患者属性；程序方法与技术；医院;外科医生和机构特点；纵向患者功能，术后并发症和修复，以及血清/DNA样本。基于web的数据收集将提高数据收集的效率。研究小组将开发新的结果测量方法，并确定患者因素、技术使用和运送因素对(1)早期功能衰竭和(2)关节置换术后不良事件的相对影响；(3)检查TJR使用和结果的差异，寻求阐明根本原因；(4)进行经济分析，以确定劳动年龄成人TJR的个人和社会价值。一个全国性的骨科医生网络将与具有创新精神的科学家合作，他们在大规模注册表的开发和实施、基于网络的技术、结果测量和统计技术方面具有专业知识，以确保成功。健全的治理原则将确保有效实施。登记处将积极鼓励辅助研究，以确保所有数据和生物材料的最佳利用。我们建议将临床中心和骨科办公室的网络转变为一个研究实验室，作为比较有效性研究的国家模式。

DESCRIPTION (provided by applicant): Each year, more than 700,000 US adults elect total joint replacement (TJR) surgery to restore physical function and eliminate the pain of advanced knee or hip arthritis that persists despite comprehensive medical treatment. Despite broad use, wide variation persists in surgical practice and outcomes. Furthermore, there is a lack of comparative effectiveness data to guide surgeon and patient decisions on optimal implant timing, surgical approach, implant selection, and peri-operative management to prevent adverse sequelae and revision. Therefore, the National Orthopedic Outcome Registry (NOOR) and Cohort Study will establish a national registry of over 33,000 diverse patients of 130 orthopedic surgeons representing all regions of the country and varied hospital and surgeon practice settings. As such, the registry is designed to reflect typical US clinical practice, rather than focusing exclusively on high-volume academic centers. Data will include baseline patient attributes; procedure approach and technology; hospital course; surgeon and institutional characteristics; longitudinal patient function, post-procedure complications and revisions, and serum/DNA samples. Web-based data collection will enhance efficient data gathering. The research team will develop new outcome measures and will determine the relative contributions of patient factors, technology use, and delivery factors to (1) early functional failure and (2) adverse post-arthroplasty events; (3) examine disparities in TJR use and outcome, seeking to elucidate root causes; and (4) conduct economic analyses to determine the personal and societal value of TJR in working aged adults. A national network of orthopedists will partner with innovative scientists with expertise in large-scale registry development and implementation, web-based technology, outcome measurement, and statistical techniques to assure success. Sound governance principles will ensure efficient implementation. The registry will actively encourage ancillary research to assure optimal use of all data and biomaterials. We propose to transform the network of clinical centers and orthopedic offices into a research laboratory that will serve as a national model for comparative effectiveness research. PUBLIC HEALTH RELEVANCE: The proposed national orthopedic outcome registry will collect important patient, surgical, and delivery setting data to answer critical patient and surgeon questions about optimal implant selection, surgical timing and approach, and peri-operative care for the large number of patients who undergo total joint replacement and other procedures each year. Research will also address TJR value in young patients and use disparities,