Muscle Function Following Anterior Cruciate Ligament Reconstruction: Impaired Power Output in Physically Active Individuals (ReGAIN)
2026年8月10日 更新者：Centre Hospitalier Metropole Savoie
The goal of this clinical trial is to to determine the extent of the association between objective changes in the muscle function of the knee extensors (strength and power) and the function reported by the patient following ACL reconstruction surgery. The main questions it aims to answer is:
- Pre- and post-operative (6 months) changes in maximum knee extensor strength following ACL reconstruction, correlated with the IKDC-SKF score.
研究概览
详细说明
Before surgery :
- The patient will undergo a series of assessment tests, including:
- An assessment of the force-velocity and power-velocity relationships for each leg during a cycling task
- An assessment of unilateral force-velocity and power-velocity relationships during a knee extension task
- An assessment of maximum strength and explosive strength in isometric (static) mode of the knee extensors.
- A questionnaire-based assessment of IKDC-SKF scores. Evaluations will be repeated at 3 and 6 month after surgery ; Patients will be monitored for up to 24 months following their surgery
研究类型
介入性
注册 (估计的)
110
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：leo blervaque
- 电话号码：04.79.96.58.13
- 邮箱：leo.blervaque@ch-metropole-savoie.fr
学习地点
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Challes-les-Eaux、法国、73190
- 招聘中
- Médipôle de Savoie
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接触：
- Vincent Morin
- 电话号码：04 79 26 80 80
- 邮箱：urc@ch-metropole-savoie.fr
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Patients requiring isolated or complex ACL reconstruction (combined with a meniscal injury)
- Patients who are physically active (Tegner score ≥ 4) and wish to resume such activity.
- Patients with no history of surgery on the ipsilateral knee (i.e., native knee).
- Patients able to comply with the study procedures
- Patients who have given their free and informed written consent, having been informed of the purpose of the study, its procedure and its risks.
- Be affiliated to a social security scheme.
Exclusion Criteria:
- Patient with comprehension difficulties
- Recurrent rupture of the ipsilateral ACL
- Multi-ligament injuries (i.e., injury to the medial collateral ligament, lateral collateral ligament or posterior cruciate ligament)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：evaluated group
assessment of knee function before and after cruciate ligament surgery
|
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Correlation of maximum knee extension strength to IKDC-SKF scores
大体时间：6 month
|
Relationship (r coefficient) between 0-6 month delta of maximum knee extension strength measurements and International Knee Documentation Commitee-SKF scores (100: no limitation)
|
6 month
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Peri-operatory trajectory of maximal dynamic force
大体时间：0, 3 and 6 month
|
Trajectory of evolution of F0 (maximal dynamic force) between baseline, 3 and 6 months, compared between legs (linear mixed effect model).
|
0, 3 and 6 month
|
|
Peri-operatory trajectory of maximal contraction velocity
大体时间：0, 3 and 6 month
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Trajectory of evolution of V0 (maximal contraction velocity) between baseline, 3 and 6 months, compared between legs (linear mixed effect model).
|
0, 3 and 6 month
|
|
Peri-operatory trajectory of rate of force development
大体时间：0, 3 and 6 month
|
Trajectory of evolution of rate of force development between baseline, 3 and 6 months, compared between legs (linear mixed effect model).
|
0, 3 and 6 month
|
|
Peri-operatory trajectory of maximal isometric force
大体时间：0, 3 and 6 month
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Trajectory of evolution of maximal isometric force (Fmax) between baseline, 3 and 6 months, compared between legs (linear mixed effect model).
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0, 3 and 6 month
|
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Peri-operatory trajectory of maximal dynamic force during cycling
大体时间：0, 3 and 6 month
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Trajectory of evolution of maximal dynamic force (F0) during cycling between baseline, 3 and 6 months (linear mixed effect model, one fixed factor).
|
0, 3 and 6 month
|
|
Peri-operatory trajectory of maximal contraction velocity during cycling
大体时间：0, 3 and 6 month
|
Trajectory of evolution of maximal contraction velocity (V0) during cycling between baseline, 3 and 6 months (linear mixed effect model, one fixed factor).
|
0, 3 and 6 month
|
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Determinants of fonctional prognosis
大体时间：0, 3 and 24 month
|
Multivariate analysis including the IKDC-SKF score at 24 months as dependant variable and, as predictors :
|
0, 3 and 24 month
|
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Determinants of fonctional prognosis
大体时间：0, 3 and 24 month
|
Multivariate analysis including the recurrence of ACL lesion at 24 months (0/1) as dependant variable and, as predictors :
|
0, 3 and 24 month
|
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Determinants of fonctional prognosis
大体时间：0, 3 and 24 month
|
Multivariate analysis including resuming physical activity at the pre-injury level at 24 months (0/1) as dependant variable and, as predictors :
|
0, 3 and 24 month
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年6月8日
初级完成 (估计的)
2030年6月8日
研究完成 (估计的)
2030年6月8日
研究注册日期
首次提交
2026年6月1日
首先提交符合 QC 标准的
2026年8月10日
首次发布 (实际的)
2026年8月14日
研究记录更新
最后更新发布 (实际的)
2026年8月14日
上次提交的符合 QC 标准的更新
2026年8月10日
最后验证
2026年8月1日
更多信息
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