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Revision ACL Reconstruction: A Comparative Effectiveness Treatment Study

修正 ACL 重建：比较疗效治疗研究

基本信息

批准号：
10250436
负责人：
Rick W Wright
金额：
$ 58.35万
依托单位：
VANDERBILT UNIVERSITY MEDICAL CENTER
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-09-02 至 2024-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10250436
关键词：
Age Allografting American Anterior Cruciate Ligament Autologous Transplantation Back Body mass index 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 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 risk stratification standardize measure

项目摘要

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.

项目总结/摘要前交叉韧带（ACL）重建翻修术是一种罕见但具有临床意义的骨科实践中的挑战。通常报告称，翻修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基于患者的较差结果，膝关节松弛增加、移植物失败率升高、膝关节退行性变和软骨损伤。一些已经提出了结局率较差的原因，包括隧道位置受损、病理学在初次重建期间未治疗，并且更依赖同种异体移植物进行翻修。为了评估这些因素和其他因素对结果的贡献，大量患者必须识别正在进行翻修的患者并进行前瞻性随访。然而，由于相对由于任何一家临床试验机构的ACL重建翻修率都很低，因此有必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，以便进行多变量分析。出于这种记住，多中心ACL翻修研究（MARS）组是由83名外科医生组成的多中心对ACL重建翻修术进行前瞻性纵向队列分析。这是一学术和私人执业医生的混合团体，并得到了支持和认可，美国运动医学骨科学会（AOSSM）。我们之前的资助（5 R 01 AR 060846）使我们能够招募1,200多名患者，并获得两个短期（2- 年）和中期（6年）随访。本研究设计包括一个纵向前瞻性队列，我们对他们进行了基线、2年和6年的随访。在这两个随访时间点，我们能够使用经验证的患者报告结局问卷获得至少80%的随访，通过电话随访。本次补助金更新的目的是评估10年的进展情况， ACL重建翻修后的结局，并确定当时的初始因素可能影响和预测疾病进展。新的建议是，在整个队列中增加PROMIS患者报告的结局，以及增加嵌套队列，我们的目标是带回400名这些入组患者进行现场标准化X光片检查和体检措施。本次更新申请的重点是对10年自然该独特数据集的历史，通过3种互补方法进行量化：患者报告的结局，放射学和体格检查措施。这一更新将建立在第2和第6节所展示的调查结果的基础上。年，并确定这些是否继续保持真实的长期随访。