A Prospective Post Market Clinical Follow up Study to Evaluate the Safety and Performance of the Meniscus Repair System
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1. Patient reported outcomes (IKDC and KOOS) will be recorded at pre-operative visit and post-operative follow up visits to evaluate the change.
研究概览
简要总结
This is a multi-centric prospective post market clinical follow up study. The study is being done to collect more data on safety and performance of the implants used to repair meniscal tear. The specific aim of the study is to assess safety and performance of meniscus repair system. A total of 40 patients will be enrolled in the study. Total duration of study is two years.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients presenting to orthopaedic OPD or emergency with meniscus tear confirmed through MRI scan.
排除标准
- •1 Subjects with a disease entity or condition that could hinder healing and create unacceptable risk of fixation failure or complications such as known active cancer, neuromuscular disorder etc.
- •2 Subject with inadequate tissue coverage at the operative sites.
- •3 Patients with concomitant ligamentous injury.
- •4 Patient with history of meniscus surgery.
- •5 Patients with known history of metal allergies.
- •6 Patients with documented mental disorders.
- •7 Patients with life-threatning conditions.
- •8 Subjects who are incarcerated or have pending incarceration.
- •9 Associated other fractures which may interfere the rehabilitation and timely surgical fixation.
结局指标
主要结局
1. Patient reported outcomes (IKDC and KOOS) will be recorded at pre-operative visit and post-operative follow up visits to evaluate the change.
时间窗: 6 week | 3 month | 6 month | 12 month
2. Number of individuals who have returned to pre-injury level of activities of daily living/sports activities will be recorded at each post-operative follow up visit.
时间窗: 6 week | 3 month | 6 month | 12 month
次要结局
- Adverse event (AE), and serious adverse event (SAE), if any will be recorded at each post-operative follow up visit to assess the meniscus repair system.(6 week)
研究者
Dr Mohd Aslam
Auxein Medical Pvt Ltd