NCT04310956已完成不适用
A Multi-center, Randomized Controlled Trial to Evaluate the Effectiveness and Safety of Y-Knot All-suture Anchor in Ankle Ligaments Injury Repair
ConMed Linvatec Beijing4 个研究点 分布在 1 个国家目标入组 148 人开始时间: 2019年12月23日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 148
- 试验地点
- 4
- 主要终点
- improvement of AOFAS score
研究概览
简要总结
Purpose of this study is to evaluate the effectiveness and safety of Y-Knot all-suture anchor by comparing patients' clinical outcome after ankle ligaments repair surgery.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female, no less than 18 years old;
- •Patient was diagnosed as Collateral Ligament injury or Achilles tendon injury based on MRI or X-Ray who need to conduct foot&ankle repair surgery by investigator;
- •Patient willing to sign a written consent form participating in this study；
- •Subject is able to understand study, willing to comply the study procedures, and willing to return to hospital for follow-up up to 6 months postoperative；
- •Life expectancy is more than 2 years post-operationally;
排除标准
- •Conducted surgery at index ankle and possibly influence the outcome evaluation;
- •Bilateral ankle surgery;
- •Suffering concurrent ankle disease that may leads to a surgery during the study phase;
- •known or suspected allergies to implant and/or instrument materials;
- •pathological conditions of bone which would adversely affect the anchor fixation; with concurrent severe injury at index leg that may influence the outcome evaluation; Severe obesity;
- •With concurrent disease that may influence the index ankle function;
- •Patients with active sepsis or infection;
- •With concurrent disease that may influence the stability of device and rehabilitation;
- •Immune suppression, impairment of immune function, or autoimmune disease;
- •Pregnant or lactating women;
- •Known noncompliance or lost follow-up risk;
- •Participated other drug, biologic, or device clinical trial 12 months before enrollment;
- •Alcohol or drug abuser;
- •Other inappropriate condition based on investigator determination;
结局指标
主要结局
improvement of AOFAS score
时间窗: From pre-operation to 6 months postoperative
次要结局
- improvement of AOFAS score(From pre-operation to 3 months postoperative)
- ligament injury recurrences(up to 6 months postoperative)
- secondary surgery(up to 6 months postoperative)
- Improvement of VAS score(From pre-operation to 3 and 6 months postoperative)
研究者
研究点 (4)
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