Assessment of the Results of Combined Anterolateral Ligament (ALL) + Antero Crusader Ligament (ACL) Plasty Compared to Classical KJ Plasty in Isolated ACL Ruptures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 592
- 试验地点
- 2
- 主要终点
- Ligament re-rupture rate
研究概览
简要总结
The aim of the study is to show a reduction of a re-rupture rate with an ACL (antero crusader ligament) + ALL (anterolateral ligament) combined technique compared to a classical Kenneth-Jones ACL (antero crusader ligament) reconstruction technique.
详细描述
The aim is to evaluate the rate of re-rupture and to analyze knee function through scores analysis as International Knee Documentation Committee Subjective Knee (IKDC), Knee injury and osteoarthritis outcome score (KOOS), Lysholm-Tegner, and by objective measurements of laximetry and rotation.
This study should include 2 groups of 296 patients with isolated ACL (antero crusader ligament) with clinical rotation :
- operated by a conventional patellar tendon technique (first group)
- operated by a technique combining a ALL (anterolateral ligament) and ACL plasty for the second group
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
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with total isolated antero crusader ligament (ACL) rupture who are candidates for surgical reconstruction
- •Patients between 18 and 35 years old
- •Patients with weekly sporting activities
- •Patients with chronic rotatory instability with a positive pivot shift
- •Patients who have been informed and do not object the research
排除标准
- •Patients with multi-ligament knee involvement
- •Patients under 18 years old or over 35 years old
- •Patients with a BMI of under 18.5 or over 30
- •Patients with any contraindication to general anaesthesia
- •Professional sportsmen/women
- •Patients with congenital malformation or a rheumatic disease
- •Patients with repeated antero crusader ligament (ACL) rupture
- •Patients with serious ligament disease in the contralateral knee
- •Patients who refuse to take part in the study
研究组 & 干预措施
ACL plasty
The surgical procedure consists of a ligamentoplasty of the antero crusader ligament (ACL) with the patellar tendon according to a conventional arthroscopic procedure.
干预措施: ACL plasty (Procedure)
ACL + ALL plasty
The surgical procedure consists of a hamstring ligamentoplasty (DIDT) of the antero crusader ligament (ACL) and anterolateral ligament (ALL) according to a published arthroscopic procedure.
干预措施: ACL + ALL plasty (Procedure)
结局指标
主要结局
Ligament re-rupture rate
时间窗: 3 years
Clinical instability, laximetry, IRM
次要结局
- International Knee Documentation Committee Subjective Knee (IKDC) clinical score(preoperatively, 1 year and 3 years)
- Tegner Lysholm score(Preoperatively, 1 year and 3 years)
- Knee injury and osteoarthritis outcome score (KOOS) clinical score(preoperative, 1 year and 3 years)
- Rolimeter test(pre-operatively, 6 months, 1 year and 3 years)
- KiRA test(preoperatively, 6 months and 3 years)
- Knee radiography(preoperatively and 3 years)