Revision ACL Reconstruction: A Comparative Effectiveness Treatment Study

修正 ACL 重建：比较疗效治疗研究

• 批准号: 10019326
• 负责人: Rick W Wright
• 金额: $ 63.3万
• 依托单位: VANDERBILT UNIVERSITY MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-02 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10019326
• 关键词: Age; Allografting; American; Anterior Cruciate Ligament; Autologous Transplantation; Back; Clinical; Cohort Analysis; Data Set; Disease Progression; Enrollment; Gender; Grant; Individual; Inferior; Joints; Knee; Knee Osteoarthritis; Lesion; Location; Longitudinal cohort; Longterm Follow-up; Measures; Meniscus structure of joint; Methodology; Mind; Modeling; Multicenter Studies; Natural History; Online Systems; Operative Surgical Procedures; Orthopedics; Outcome; Pain; Pathology; Patient Outcomes Assessments; Patient-Focused Outcomes; Patients; Physicians; Private Practice; Prospective Studies; Prospective cohort; Questionnaires; Radiology Specialty; Repeat Surgery; Reporting; Research Design; Risk Factors; Roentgen Rays; Rupture; SF-36; Societies; Sports Medicine; Standardization; Structure; Surgeon; Telephone; Time; Treatment Effectiveness; Weight-Bearing state; Western Ontario and McMaster Universities Arthritis Index; anterior cruciate ligament reconstruction; articular cartilage; base; clinical predictors; cohort; comparative effectiveness; follow-up; graft failure; improved; outcome prediction; personalized risk prediction; prospective; reconstruction; risk prediction model; standardize measure

PROJECT SUMMARY/ ABSTRACT Revision anterior cruciate ligament (ACL) reconstruction represents an infrequent but clinically important challenge in orthopaedic practice. It is commonly reported that the results of revision surgery remain inferior to primary ACL reconstructions. These poorer outcomes include worse patient based outcomes, increased knee laxity, higher graft failure rate, meniscal degeneration, and chondral lesions. A number of reasons for the poorer outcome rate have been proposed, including compromised tunnel location, pathology untreated during the primary reconstruction, and greater reliance on allografts for revisions. In order to evaluate the contributions of these and other factors to outcome, large numbers of patients who are undergoing revisions must be identified and followed prospectively. However, due to the relative infrequency of revision ACL reconstructions in any one center, a large multicenter study is necessary to accumulate enough subjects over a reasonable time frame to allow for multivariable analyses. With this in mind, the Multicenter ACL Revision Study (MARS) group was established as an 83 surgeon multicenter consortium to perform a prospective longitudinal cohort analysis of revision ACL reconstruction. This is a mixed group of academic and private practice physicians and has been supported and endorsed by the American Orthopedic Society for Sports Medicine (AOSSM). Our previous grant (5R01 AR060846) has allowed us to enroll over 1,200 patients and obtain both short (2- year) and mid-term (6-year) follow-up. This study design involves a longitudinal prospective cohort for whom we have baseline, 2-year and 6-year follow-up on. At both follow-up time points, we have been able to obtain a minimum of 80% follow-up using validated patient-reported outcome questionnaires and 92% via phone follow-up. The objective of this grant renewal is to assess the 10-year progression of outcomes following revision ACL reconstruction, and to determine how the initial factors at the time of revision surgery may influence and predict disease progression. New to this proposal is the addition of PROMIS patient reported outcomes to the entire cohort, as well as the addition of a nested cohort, for which we aim to bring back 400 of these enrolled patients for onsite standardized radiographs and physical exam measures. The focus of this renewal application is to characterize the 10-year natural history of this unique dataset, quantified by 3 complementary methodologies: patient-reported outcomes, radiologic and physical exam measures. This renewal will build upon the findings demonstrated at 2 and 6 years and determine if these continue to hold true at long-term follow-up.

项目概要/摘要 前十字韧带 (ACL) 修复重建是一种罕见但具有临床意义的手术 骨科实践中的挑战。据报道，修复手术的结果仍然存在 不如初次 ACL 重建。这些较差的结果包括较差的基于患者的结果， 膝关节松弛增加、移植物失败率更高、半月板变性和软骨病变。一些 已经提出了较差结果率的原因，包括隧道位置受损、病理学 在初次重建期间未经治疗，并且更多地依赖同种异体移植进行修复。为了 评估这些因素和其他因素对结果的贡献，大量患者 必须识别并前瞻性地跟踪正在进行的修订。但由于相对 在任何一个中心进行 ACL 重建修复的频率都不高，因此需要进行大型多中心研究 在合理的时间范围内积累足够的受试者以进行多变量分析。有了这个 多中心 ACL 修复研究 (MARS) 小组是由 83 名外科医生组成的多中心 联盟对 ACL 重建修复进行前瞻性纵向队列分析。这是一个 由学术和私人执业医师组成的混合团体，并得到了 美国运动医学骨科学会 (AOSSM)。 我们之前的资助 (5R01 AR060846) 使我们能够招募超过 1,200 名患者并获得短期 (2- 年）和中期（6 年）随访。本研究设计涉及纵向前瞻性队列 我们对其进行基线、2 年和 6 年随访。在两个后续时间点，我们都能够 使用经过验证的患者报告结果问卷获得至少 80% 的随访，通过 电话跟进。此次赠款续展的目的是评估 10 年的进展情况 修正 ACL 重建后的结果，并确定当时的初始因素 修复手术的发生率可能会影响和预测疾病进展。该提案的新内容是 添加 PROMIS 患者向整个队列报告结果，以及添加嵌套 我们的目标是让 400 名入组患者返回现场进行标准化 X 光检查 和体检措施。本次续签申请的重点是描述 10 年自然保护的特征 这个独特数据集的历史，通过 3 种补充方法进行量化：患者报告的结果， 放射学和体检措施。此次更新将建立在 2 和 6 中展示的调查结果的基础上 年并确定这些在长期随访中是否继续成立。