Ligamys Technique Versus Standard Technique for the Anterior Cruciate Ligament Rupture
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Measuring anterior knee laxity with KT 1000 arthrometer
研究概览
简要总结
The assess results of Anterior Cruciate Ligament (ACL) repair with the Ligamys® surgical technique versus standard technique.
The aim of the study is to compare (laxity, instability, and safety) these two types of treatment by using a prospective, randomised multicenter analysis.
详细描述
The treatment of acute ruptures of the anterior cruciate ligament is surgical in some cases with ligamentoplasty technique.
Contrary to the classic ligamentoplasty, the treatment with Ligamys consists of promoting heating of the ligament itself by controlling mechanical environment.
It allows a "dynamic" stabilization of the torn Anterior Cruciate Ligament with in the 3 weekly following traumatism. These techniques may improve the recovery process, proprioceptive results, decrease morbidity of transplant harvesting and faster for the patients. It's all these issues we would like to assess with a randomised multicenter study.
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
- None
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
- •Age between 18 to 35 years
- •Primary Anterior Cruciate Ligament rupture
- •signed patient consent
- •surgery 21 days or less after traumatism for Ligamys technique
排除标准
- •infection of the operating site
- •previous osseous disease
- •pregnant or nursing woman.
结局指标
主要结局
Measuring anterior knee laxity with KT 1000 arthrometer
时间窗: at 12 months
次要结局
- Tegnér scores(at 12 months)
- Lysholm scores(at 12 months)
- IKDC score safety(at 12 months)