Graft Type and Outcomes After ACL Reconstruction in Female Athletes (LCA-WOMEN)
2026年7月19日 更新者：Luis Gutiérrez Sánchez、Universidad Católica San Antonio de Murcia
Influence of Graft Type on Functional and Neuromuscular Outcomes After Anterior Cruciate Ligament Reconstruction in Female Athletes: A Prospective Multicenter Cohort Study
This prospective multicenter cohort study aims to compare clinical and functional outcomes between hamstring tendon and quadriceps tendon autografts in anterior cruciate ligament (ACL) reconstruction in female athletes.
Participants will be followed for two years after surgery to evaluate graft failure rates, return to sport, knee stability, and patient-reported outcomes.
研究概览
地位
尚未招聘
详细说明
Anterior cruciate ligament injuries are particularly prevalent in female athletes and represent a major challenge in sports medicine.
The choice of graft type in ACL reconstruction may influence clinical outcomes, yet evidence specifically in female populations remains limited.
This study prospectively enrolls female athletes undergoing ACL reconstruction with either hamstring tendon or quadriceps tendon autograft across multiple centers in Spain.
Primary outcome is graft failure rate at 24 months.
Secondary outcomes include return to sport rate, IKDC score, KOOS, Lysholm scale, limb symmetry index, and re-injury rate.
Data will be collected preoperatively and at 6, 12, and 24 months postoperatively.
研究类型
观察性的
注册 (估计的)
82
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：Luis Gutiérrez Sánchez, MD
- 电话号码：625733811
- 邮箱：luis_gutierrez_sanchez@hotmail.com
学习地点
-
-
Alicante
-
Alicante、Alicante、西班牙、03540
- IMED Hospitales
-
接触：
- Luis Gutiérrez Sánchez, MD
- 电话号码：+34625733811
- 邮箱：luis_gutierrez_sanchez@hotmail.com
-
-
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
- 孩子
- 成人
接受健康志愿者
不
取样方法
非概率样本
研究人群
Female athletes aged 16 to 35 years undergoing primary ACL reconstruction with either hamstring tendon or quadriceps tendon autograft across multiple sports medicine centers in Spain.
描述
Inclusion Criteria:
- Female patients aged 16 to 35 years with skeletal maturity
- Active athlete: minimum two training sessions per week during the six months prior to injury in pivoting sports
- Confirmed complete ACL rupture by MRI and clinical examination
- Primary ACL reconstruction (first ligament surgery on the index knee)
- Time from injury to surgery no longer than 6 months
- Signed informed consent
Exclusion Criteria:
- Previous ligament surgery on either knee
- Multiligament injury: simultaneous PCL, grade III MCL or LCL injury
- Neuromuscular, rheumatological or systemic pathology interfering with rehabilitation or functional assessments
- Pre-existing radiological osteoarthritis grade Kellgren-Lawrence ≥2 in the index knee
- Inability to complete 24-month follow-up protocol
- Pregnancy at inclusion or during follow-up period
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
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Hamstring tendon autograft
Female athletes undergoing ACL reconstruction with hamstring tendon autograft
|
ACL reconstruction using ipsilateral hamstring tendon autograft (semitendinosus and gracilis tendons) with arthroscopic technique
|
|
Quadriceps tendon autograft
Female athletes undergoing ACL reconstruction with quadriceps tendon autograft
|
ACL reconstruction using ipsilateral quadriceps tendon autograft with arthroscopic technique
|
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 |
|---|---|---|
|
Graft failure rate
大体时间：24 months after surgery
|
Proportion of patients requiring revision ACL reconstruction or presenting with objetive graft rupture confirmed by MRI or arthroscopy
|
24 months after surgery
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
return to sport rate
大体时间：12 and 24 months after surgery
|
proportion of athletes who returned to their pre-injury sport level, assessed by athlete and surgeon
|
12 and 24 months after surgery
|
|
IKDC Subjective knee Evaluation Form
大体时间：6, 12 and 24 months after surgery
|
Patient-reported outcomes measure assessing knee symptoms, function and sports activity.
|
6, 12 and 24 months after surgery
|
|
KOOS (Knee Injury and Osteoarthritis outcome Score)
大体时间：6, 12 and 24 months after surgery
|
Patient-reported outcome measure assessing pain, symptoms, function in daily living, function in sport and recreation, and knee-related quality of life
|
6, 12 and 24 months after surgery
|
|
Lysholm Knee Scoring Scale
大体时间：6, 12 and 24 months after surgery
|
Clinician-reported outcome measure assessing knee function including pain, instability, locking, swelling, stair climbing, squatting and limp
|
6, 12 and 24 months after surgery
|
|
Limb Symetry Index (LSI)
大体时间：6, 12 and 24 months after surgery
|
Assessed vy isokinetic dynamometry and single-leg hop tests to evaluate quadriceps and hamstring strength symmetry between limbs
|
6, 12 and 24 months after surgery
|
|
Re-injury rate
大体时间：24 months after surgery
|
Proportion of patients sustaining a new ipsilateral or contralateral ACL injury during the follow-up period.
|
24 months after surgery
|
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 (估计的)
2026年8月1日
初级完成 (估计的)
2028年8月1日
研究完成 (估计的)
2028年12月1日
研究注册日期
首次提交
2026年7月19日
首先提交符合 QC 标准的
2026年7月19日
首次发布 (实际的)
2026年7月23日
研究记录更新
最后更新发布 (实际的)
2026年7月23日
上次提交的符合 QC 标准的更新
2026年7月19日
最后验证
2026年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.