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炎的疼痛，尽管进行了全面的医学治疗，这种疼痛仍然存在。尽管广泛使用，但手术实践和结局仍存在很大差异。此外，缺乏比较有效性数据来指导外科医生和患者决定最佳植入时机、手术入路、植入物选择和围手术期管理，以防止不良后遗症和翻修。因此，国家骨科结局登记研究（NOOR）和队列研究将建立一个由130名骨科医生组成的33，000多名不同患者的国家登记研究，这些医生代表了该国所有地区和不同的医院和外科医生实践环境。因此，该登记研究旨在反映典型的美国临床实践，而不是仅关注高容量的学术中心。数据将包括基线患者属性;手术方法和技术;住院过程;外科医生和机构特征;纵向患者功能、术后并发症和翻修以及血清/DNA样本。基于网络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局指标，并确定患者因素、技术使用和分娩因素对（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使用和结局的差异，寻求阐明根本原因;（4）进行经济分析，以确定TJR在工作年龄成人中的个人和社会价值。一个全国性的整形外科医生网络将与具有大规模注册开发和实施、基于网络的技术、结果测量和统计技术方面专业知识的创新科学家合作，以确保成功。健全的治理原则将确保有效执行。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.