CTRI/2025/09/094473招募中Unknown
A Prospective Post Market Clinical Follow up Study to Evaluate the Safety and Performance of the ACL Repair System
Auxein Medical Pvt Ltd1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年9月25日最近更新:
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
- Performance of Auxilock ACL Repair System will be assessed by improvement in KOOS score from pre-operative to post-operative follow-up visits
研究概览
简要总结
This is a multi-centric prospective PMCF study. The study aims to assess safety and performance of ACL 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 with confirmed ACL injury and who are planned for ACL repair through arthroscopy surgery.
排除标准
- •1 Patients 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 Patient has inadequate tissue coverage of the operative site.
- •3 Patients with concomitant meniscus or soft tissue injury.
- •4 Patient with history of effected ACL surgery 5 Patients with known history of metal allergies 6 Patients with documented mental disorders 7 Patients with life-threatning conditions 8 Patients 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
Performance of Auxilock ACL Repair System will be assessed by improvement in KOOS score from pre-operative to post-operative follow-up visits
时间窗: 6 week | 3 month | 6 month | 12 month
次要结局
- 1 Visual analogue scale (VAS) score will be recorded at pre-operative visit and post-operative follow up visits for assessment of improvement in pain
研究者
Dr Mohd Aslam
Auxein Medical Pvt Ltd
研究点 (1)
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