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; 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.

项目摘要/摘要 这项纵向结果研究的目标是评估创伤后的进展 在男性和 手术后15年的女性患者，并确定在 手术和性别影响与关节有关的长期结局。 ACL的破坏是常见的伤害 这通常需要手术重建以恢复功能并防止PTOA。 “初始移植张力” 手术时应用的调节联合接触力学又可能促进PTOA。然而， 低初始移植紧张张力对PTOA发育的影响尚不清楚。还知道性爱 是ACL损伤和随后的移植失败的危险因素。那是女性的风险增加 手术后的PTOA。拟议的工作将利用一组ACL重建患者的队列 先前参加了一项随机对照试验，以研究初始移植张力的影响。患者，谁 用自体移植进行ACL重建的候选者被随机分为两个治疗组之一：1） 初始移植张力集，使重建的膝盖的前后骨（AP）松弛等于 对侧正常膝盖（“低张力”治疗； n = 46）和2）最初的移植张力设置以减少AP 相对于对侧膝盖的膝盖松弛2毫米（“高张紧”治疗； n = 44）。另一个 招募了没有膝盖损伤证据的受试者组（n = 60），以作为未受伤的对照。在 以前的资金周期，我们发现两者之间出现的几种结果指标的差异 在3年随访中不存在的7年随访中的初始移植张力组。在此提案中， 该患者队列及其匹配的对照组的后续措施将延长至15年，这个时间点将 使我们能够清楚地识别出具有射线照相和有症状PTOA的患者。这 第一个假设是“高张力”队列重建膝盖的胫骨关节空间宽度将 等于对照组的，而“低张紧”队列的组将小于对照组 ACL重建15年后的组。第二个假设是中位关节空间宽度下降 与男性患者相比，在ACL重建后，女性患者将更大。综合套装 要使用的结果包括成像模式以监测PTOA开发和其他经过验证的患者 - 报告，临床和功能测量。 X射线尺寸的关节宽度被认为是唯一的 经过验证的PTOA进展指标用于膝盖的临床试验，并将作为主要结果 拟议研究的量度。关节健康评估（OARSI评分）和MR基于MR 关节健康（蠕虫）的度量将作为次要成像结果。膝盖骨关节炎 结果评分（KOO）将用于确定哪些患者有症状PTOA。综合 一组结果将使我们能够建立初始移植张力的长期影响，并系统地建立 评估ACL重建手术后性别对PTOA发育的影响。拟议的研究是 小说，因为ACL重建的队列由当时孤立的单侧ACL损伤患者组成 伤害包括评估这些患者PTOA开发所需的长期随访，以及 包括一个匹配的对照组，以比较未受伤的人群中的关节炎发展。