Examining Anterior Cruciate Ligament Reconstruction With Quadriceps- vs. Semitendinosus Tendon Graft for Young Federated Male Football Players.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Lower limb strength
研究概览
简要总结
To investigate the differences between the two methods for reconstruction of the anterior cruciate ligament (ACL), to support the development of the best method for young federated male football players. After surgery with quadricipital tendon graft or semitendinosus tendon graft, a two-year follow-up and the rate of return to sport are proposed.
详细描述
The anterior cruciate ligament is one of the most common traumatic injuries in football, and surgery is proposed to restore knee stability. However, following surgery, few studies have focused on functional recovery of the knee with a wide arsenal of physical tests. Therefore, this study aims to study the efficacy for young football players of two types of grafts based on the most common tendons, the quadricipital and the semitendinosus (without the semimembranosus). Follow-ups will be performed at three months, six months, one year and two years after reconstruction. The variables measured will be isokinetic strength of flexors and extensors, unipodal jump test, self-perceived function, pain and tendon architecture with ultrasound.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 40 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Confirmed anterior cruciate ligament rupture by MRI.
- •Prognosis of anterior cruciate ligament reconstruction surgery.
- •Be a registered or recreational football player.
排除标准
- •Previous knee surgery.
- •Having articular cartilage lesions of Outerbridge grade greater than III-IV.
研究组 & 干预措施
Semitendinosus tendon graft
Surgical reconstruction of primary ACL rupture with autograft harvested from the semitendinosus tendon (ST).
The ST graft is harvested through a 4-5 cm incision at the pes anserinus. The semitendinosus is identified and harvested. The tendon is prepared and folded to a four-stranded graft with a total diameter of 8-11 mm.
The femoral tunnel is placed anatomically central in the native footprint of the ACL. The tibia tunnel is also placed anatomically; the center of the tunnel being medially between the eminential spines at the level of the posterior margin of the anterior horn of the lateral meniscus.
The quadrupled ST graft is fixed proximally with the RIGIDLOOP® adjustable cortical system (DePuy Synthes) and distally with the RIGIDLOOP® XL adjustable cortical system.
干预措施: ACL reconstruction (Procedure)
Quadriceps tendon graft
Surgical reconstruction of primary ACL rupture with autograft harvested from the quadriceps tendon (QT) without bone block.
The QT graft is harvested through a 4-5 cm incision at the upper pole of the patella. A graft sized 10-12 mm in with and app. 6 mm in depth is harvested from the middle part of the tendon.
The femoral tunnel is placed anatomically central in the native footprint of the ACL. The tibia tunnel is also placed anatomically; the center of the tunnel being medially between the eminential spines at the level of the posterior margin of the anterior horn of the lateral meniscus.
The QT graft is fixed proximally with the RIGIDLOOP® adjustable cortical system (DePuy Synthes) and distally with the RIGIDLOOP® XL adjustable cortical system
干预措施: ACL reconstruction (Procedure)
结局指标
主要结局
Lower limb strength
时间窗: Participants will be followed over 24 months
assessed by an isokinetic test with an isokinetic dynamometer (HUMAC NORM)
Horizontal hop test
时间窗: Participants will be followed over 24 months
assessed by horizontal jump with one leg and hands on the waist, measured with a centimetric tape (three jumping opportunities)
次要结局
- Perimeters(Participants will be followed over 24 months)
- Self-reported functionality(Participants will be followed over 24 months)
- Knee pain(Participants will be followed over 24 months)
- Pressure pain threshold(Participants will be followed over 24 months)
- Tendon ultrasound(Participants will be followed over 24 months)
研究者
Maria Lopez-Garzon
PhD
Universidad de Granada