Induced ACL Healing With the Ligamys Technique: a Prospective, Multicenter Observational Case Series
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 3
- 主要终点
- Knee stability and function plus safety aspects
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of the Ligamys technique for the treatment of acute ruptures of the anterior cruciate ligament in a multicenter routine clinical setting. To conduct a long-term follow-up of the case series as a post-market product surveillance endeavor.
详细描述
The Ligamys method was successfully applied in an animal study including eleven white alpine sheep. Healing of the torn ACL and a stable joint without signs of intra-articular damages or osteoarthritis three months postoperative were observed (Kohl KSSTA 2013). In a first clinical study with ten patients, the Ligamys surgical technique resulted in stable clinical and radiological healing of the torn ACL in nine patients with one re-rupture after four months. Nine patients obtained normal knee scores, reported excellent patient satisfaction, and could return to their previous levels of sporting activity (Kohl Swiss Med Wkly 2011).
The purpose of this study is to evaluate the safety and effectiveness of the Ligamys technique for the treatment of acute ruptures of the anterior cruciate ligament in a multicenter routine clinical setting. To conduct a long-term follow-up of the case series as a post-market product surveillance endeavor.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary rupture of the anterior cruciate ligament
- •Signed patient informed consent
- •Willingness to present for follow-up
- •Age between 18 and 50 years at the time of inclusion in the study
- •Injury - surgery time interval of 21 days or less
排除标准
- •Medical non-compliance
- •Unwillingness to follow the rehabilitation programme
- •Traumatic cartilage lesion requiring cartilage repair procedure (Microfracturing, MACI, ACT) or degenerative cartilage lesions (Outerbridge >ll and defect >1cm2)
- •Non-repairable meniscus lesions requiring a resection of >20%
- •Previous tendon removal on injured leg
- •Relevant permanent medication (Steroids, cytostatic drugs, ...)
- •Pregnancy
结局指标
主要结局
Knee stability and function plus safety aspects
时间窗: 12 months follow-up
Knee stability: Lachman test Knee function: Lysholm score, IKDC score Safety: ACL re-ruptures or instabilities leading to an implant removal
次要结局
- Patient satisfaction, work absence, activity, pain and secondary degenerative changes of the knee joint(10 years follow-up)