Performance and Safety of the Composite Interference Screw Used in Anterior Cruciate Ligament Reconstructions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Biomatlante
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Change of the objective International Knee Documentation Committee score before and after surgery
研究概览
简要总结
The evaluation of the clinical data has demonstrated the conformity of the Composite Interference Screw (CIS), with the relevant essential requirements for its use in orthopaedic applications. The Composite Interference Scres are intended for tibial and femoral ligament/graft fixation in the case or Anterior Cruciate Ligament (ACL) reconstructions. It has been concluded that the risks associated with the use of the device are acceptable when weighted against the benefits to the patients. In order to improve the clinical data on the CIS, the manufacturer, Biomatlante, decided to assess that the performance and safety of the device are maintained until the reaching of its intended use. In this objective, the goal of this study will be to observe the following parameters:
- Objective IKDC score (clinical evaluation)
- Subjective IKDS score (functional evaluation)
- Safety (report of any adverse event)
- Follow-up of the patient's recovery
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute or chronic ACL deficiency with complete or partial lesion of the anteromedial bundle requiring primary reconstruction of the Anterior Cruciate Ligament with hamstring tendons
- •Males or females aged froù 18 to 60 years
- •No history of surgery on the affected knee
- •Patients not under guardianship or judicial protection
- •Signature of non opposition form (consent of the patient
排除标准
- •History of ligament, meniscal surgery or fracture of the affected knee
- •Pregnancy of breastfeeding women
结局指标
主要结局
Change of the objective International Knee Documentation Committee score before and after surgery
时间窗: 4 months before surgey / 7 months post-surgery
Record of the objective International Knee Documentation Committee score (A = normal, B = almost normal, C = abnormal or D = very abnormal)
Change of the subjective International Knee Documentation Committee score before and after surgery
时间窗: 4 months before surgey / 7 months post-surgery
Record of the subjective International Knee Documentation Committee score (from 1 to 100 where 100 is the best result)
次要结局
- Number and precise description of any adverse event during the follow-up(Before surgery until 7 months post-surgery)
- Change in the patients recovery(2 months post-surgery)