Knee Arthrosis after ACL Reconstruction: A Long-term Cohort Study with Matched Controls

ACL 重建后的膝关节病：一项具有匹配对照的长期队列研究

• 批准号: 10159846
• 负责人: Braden C Fleming
• 金额: $ 30.92万
• 依托单位: RHODE ISLAND HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-05-10 至 2023-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10159846
• 关键词: Anterior; Anterior Cruciate Ligament; Autologous Transplantation; Caring; Clinical; Clinical Research; Clinical Trials; Contralateral; Control Groups; Data; Degenerative polyarthritis; Development; Diagnostic radiologic examination; Economic Burden; Enrollment; Epidemic; Female; Femur; Frequencies; Funding; Future; Health; Image; Incidence; Injury; Joints; Knee; Knee Injuries; Knee Osteoarthritis; Knee joint; Long-Term Effects; Longitudinal Studies; Longitudinal cohort study; Longterm Follow-up; Measures; Mechanics; Medial; Modification; Monitor; Operative Surgical Procedures; Outcome; Outcome Measure; Patients; Population; Process; Protocols documentation; Randomized; Randomized Controlled Trials; Reconstructive Surgical Procedures; Reporting; Risk; Risk Factors; Roentgen Rays; Sex Differences; Sex Factors; Structure; Techniques; Time; Traumatic Arthropathy; United States National Institutes of Health; Width; Work; anterior cruciate ligament injury; anterior cruciate ligament reconstruction; base; cartilage degradation; cohort; control trial; design; follow-up; functional outcomes; functional restoration; graft failure; high risk; imaging modality; male; novel; patient oriented; prevent; primary outcome; reconstruction; recruit; retention rate; sample fixation; secondary outcome; sex; tibia; treatment group; treatment guidelines; trend; trial comparing

PROJECT SUMMARY/ABSTRACT The objectives of this longitudinal outcome study are to evaluate the progression of post-traumatic osteoarthritis (PTOA) following surgical reconstruction of the anterior cruciate ligament (ACL) in male and female patients 15 years after surgery, and to determine if the initial tension applied to the graft at the time of surgery and if sex influences long-term outcomes related to arthrosis. Disruption of the ACL is a common injury that usually requires surgical reconstruction to restore function and prevent PTOA. The “initial graft tension” applied at the time of surgery modulates joint contact mechanics, which in turn, may promote PTOA. However, the effects of low- and high-initial graft tensions on PTOA development are unknown. It is also known that sex is a risk factor for ACL injury and subsequent graft failure. Thus, it is likely that females are at increased risk for PTOA following surgery. The proposed work will leverage a cohort of ACL reconstructed patients that were previously enrolled in a randomized control trial to study the effects of initial graft tension. Patients, who were candidates for ACL reconstruction with an autograft, were randomized into one of two treatment groups: 1) initial graft tension set such that the anterior-posterior (AP) laxity of the reconstructed knee was equal to that of the contralateral normal knee (the “low-tension” treatment; n=46), and 2) initial graft tension set to reduce AP knee laxity by 2 mm relative to that of the contralateral knee (the “high-tension” treatment; n=44). An additional group of subjects without evidence of knee injury (n=60) was recruited to serve as an uninjured control. In the previous funding cycle, we found differences in several outcome measures starting to emerge between the two initial graft tension groups at 7-year follow-up that were not present at 3-year follow-up. In this proposal, the follow-up of this patient cohort and its matched control group will be extended to 15 years, a time point that will enable us to clearly identify those patients who present with both radiographic and symptomatic PTOA. The first hypothesis is that tibiofemoral joint space width of the reconstructed knees of the “high-tension” cohort will be equal to that of the control group, while that of the “low-tension” cohort will be less than that of the control group 15 years after ACL reconstruction. The second hypothesis is that decreases in medial joint space width after ACL reconstruction will be greater in female patients compared to male patients. The comprehensive set of outcomes to be used include imaging modalities to monitor PTOA development and other validated patient- reported, clinical, and functional measures. X-ray measures of joint space width are considered the only validated indicator of PTOA progression for clinical trials of the knee, and will serve as the primary outcome measure for the proposed study. Radiographic assessment of joint health (OARSI score) and a MR-based measure of joint health (WORMS) will serve as secondary imaging outcomes. The Knee Osteoarthritis Outcome Score (KOOS) will be used to identify which patients have symptomatic PTOA. The comprehensive set of outcomes will allow us to establish the long-term effects of initial graft tension, and to systematically evaluate the effects of sex on PTOA development following ACL reconstruction surgery. The proposed study is novel as the ACL reconstructed cohort is comprised of patients with isolated unilateral ACL injuries at the time of injury, includes the long-term follow-up required to assess PTOA development in these patients, and includes a matched control group in order to compare arthrosis development in the uninjured population.

项目概要/摘要 这项纵向结果研究的目的是评估创伤后应激障碍的进展情况 男性和女性前十字韧带 (ACL) 手术重建后的骨关节炎 (PTOA) 女性患者术后 15 年，并确定手术时是否对移植物施加了初始张力 手术以及性别是否影响与关节病相关的长期结果 ACL 破坏是一种常见损伤。 通常需要手术重建来恢复功能并防止 PTOA “初始移植物张力”。 手术时应用的药物可调节关节接触力学，从而可能促进 PTOA。 低和高初始移植张力对 PTOA 发育的影响尚不清楚。 是 ACL 损伤和随后的移植失败的危险因素，因此，女性发生 ACL 的风险可能更高。 手术后的 PTOA 拟议的工作将利用一组 ACL 重建患者。 之前参加了一项随机对照试验，以研究初始移植物张力的影响。 使用自体移植物重建 ACL 的候选者被随机分为两个治疗组之一：1) 初始移植物张力设定使得重建膝关节的前后（AP）松弛度等于 对侧正常膝关节（“低张力”治疗；n=46），以及 2) 设置初始移植物张力以减少 AP 膝关节相对于对侧膝关节松弛 2 毫米（“高张力”治疗；n=44）。 招募没有膝关节损伤证据的一组受试者（n = 60）作为未受伤的对照。 在上一个融资周期中，我们发现两者之间开始出现一些结果指标的差异 7 年随访时的初始移植物张力组在 3 年随访中不存在。 该患者队列及其匹配对照组的随访将延长至 15 年，这一时间点将 使我们能够清楚地识别那些同时患有放射学和症状性 PTOA 的患者。 第一个假设是“高张力”组重建膝盖的胫股关节间隙宽度将 与对照组相同，而“低张力”组则低于对照组 ACL 重建后 15 年的组第二个假设是内侧关节间隙宽度减小。 与男性患者相比，ACL 重建后女性患者的患病率更高。 所使用的结果包括监测 PTOA 发展的成像方式和其他经过验证的患者 报道的、临床和功能性的关节间隙宽度测量被认为是唯一的。 膝关节临床试验中 PTOA 进展的经过验证的指标，并将作为主要结果 关节健康的放射学评估（OARSI 评分）和基于 MR 的测量。 关节健康指标（WORMS）将作为膝骨关节炎的次要影像结果。 结果评分 (KOOS) 将用于确定哪些患者患有有症状的 PTOA。 一系列结果将使我们能够确定初始移植物张力的长期影响，并系统地 评估性别对 ACL 重建手术后 PTOA 发育的影响。 新颖的是，ACL 重建队列由当时孤立的单侧 ACL 损伤的患者组成 损伤情况，包括评估这些患者 PTOA 发展所需的长期随访，以及 包括一个匹配的对照组，以便比较未受伤人群的关节发育情况。