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

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:
依托单位国家:
美国
项目类别:
财政年份:
2019
资助国家:
美国
项目状态:
已结题
起止时间:
2019-05-10 至 2023-04-30

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中文摘要
翻译
项目总结/摘要 这项纵向结果研究的目的是评估创伤后的进展, 男性前交叉韧带(ACL)手术重建后的骨关节炎(PTOA), 术后15年的女性患者,并确定是否在移植时施加初始张力 手术和性别是否影响关节病相关的长期结局。前交叉韧带断裂是一种常见的损伤 通常需要手术重建以恢复功能并防止PTOA。“初始移植物张力” 在手术时施加的药物调节关节接触力学,这反过来可以促进PTOA。但是,在这方面, 低和高初始接枝张力对PTOA发展的影响是未知的。众所周知,性 是ACL损伤和随后移植物失败的危险因素。因此,很可能女性的风险增加, 手术后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,研究初始移植物张力的影响。例患者 自体移植物ACL重建的候选者被随机分为两个治疗组:1) 初始移植物张力设置,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),和2)初始移植物张力设置为降低AP 相对于对侧膝关节的膝关节松弛度,膝关节松弛度降低2 mm(“高张力”治疗; n=44)。额外 招募一组没有膝关节损伤迹象的受试者(n=60)作为未受伤的对照。在 在上一个融资周期,我们发现两者之间开始出现几个结果指标的差异 7年随访时的初始移植物张力组,3年随访时不存在。在本提案中, 该患者队列及其匹配对照组的随访将延长至15年, 使我们能够清楚地识别那些同时存在放射学和症状性PTOA的患者。的 第一个假设是“高张力”组群的重建膝关节的胫股关节间隙宽度将 与对照组相同,而“低张力”队列的血压低于对照组 ACL重建术后15年组。第二个假设是内侧关节间隙宽度的减小 女性患者ACL重建后的疼痛程度高于男性患者。一整套全面 使用的结局包括监测PTOA发展的成像模式和其他经验证的患者- 报告、临床和功能测量。关节间隙宽度的X射线测量被认为是唯一的 膝关节临床试验中PTOA进展的有效指标,并将作为主要结局 为拟议的研究。关节健康的放射学评估(OARSI评分)和基于MR的 关节健康指标(蠕虫)将作为次要成像结果。膝骨性关节炎 结局评分(KOOS)将用于确定哪些患者有症状性PTOA。综合 一组结果将使我们能够建立初始移植物张力的长期影响,并系统地 评价性别对ACL重建手术后PTOA发展的影响。拟定研究 新的ACL重建队列由当时孤立的单侧ACL损伤患者组成 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,以比较未受伤人群中关节病的发展。
英文摘要
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.
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Knee Arthrosis after ACL Reconstruction: A Long-term Cohort Study with Matched Controls
  • 批准号:
    10424422
  • 项目类别:
  • 资助金额:
    $31.56万
  • 财政年份:
    2019
  • 负责人:
    Braden C Fleming
  • 依托单位:
Planning A Clinical Trial of Bio-enhanced ACL Repair versus ACL Reconstruction
  • 批准号:
    9233601
  • 项目类别:
  • 资助金额:
    $44.45万
  • 财政年份:
    2017
  • 负责人:
    Braden C Fleming
  • 依托单位:
Non-invasive assessment of ligament healing in vivo
  • 批准号:
    8928046
  • 项目类别:
  • 资助金额:
    $56.98万
  • 财政年份:
    2014
  • 负责人:
    Braden C Fleming
  • 依托单位:
Non-invasive assessment of ligament healing in vivo
  • 批准号:
    8759439
  • 项目类别:
  • 资助金额:
    $56.27万
  • 财政年份:
    2014
  • 负责人:
    Braden C Fleming
  • 依托单位:
海外基金