Influence of Graft Type on Functional and Neuromuscular Outcomes After Anterior Cruciate Ligament Reconstruction in Female Athletes: A Prospective Multicenter Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Graft failure rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 35 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Hamstring tendon autograft
Female athletes undergoing ACL reconstruction with hamstring tendon autograft
干预措施: Hamstring tendon autograft ACL reconstruction (Procedure)
Quadriceps tendon autograft
Female athletes undergoing ACL reconstruction with quadriceps tendon autograft
干预措施: Quadriceps tendon autograft ACL reconstruction (Procedure)
结局指标
主要结局
Graft failure rate
时间窗: 24 months after surgery
Proportion of patients requiring revision ACL reconstruction or presenting with objetive graft rupture confirmed by MRI or arthroscopy
次要结局
- return to sport rate(12 and 24 months after surgery)
- IKDC Subjective knee Evaluation Form(6, 12 and 24 months after surgery)
- KOOS (Knee Injury and Osteoarthritis outcome Score)(6, 12 and 24 months after surgery)
- Lysholm Knee Scoring Scale(6, 12 and 24 months after surgery)
- Limb Symetry Index (LSI)(6, 12 and 24 months after surgery)
- Re-injury rate(24 months after surgery)
研究者
Luis Gutiérrez Sánchez
PhD Student
Universidad Católica San Antonio de Murcia