NCT02042846Unknown不适用
Prospective Clinical Evaluation of the Bioabsorbable SportWelding FijiAnchor® for Ligament Repair of the Hand and Hand Wrist
SportWelding GmbH1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2014年1月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Operation success
研究概览
简要总结
The SportWelding FijiAnchor is an absorbable suture anchor which is inserted by applying ultrasonic energy. This provides an intimate bond between implant and bone delivering immediate stability.
The purpose of this study is to evaluate the surgical and clinical outcome of the SportWelding Fiji Anchor in ligament repair of the hand and hand wrist.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Having a condition requiring (re)fixation or (re)construction of ligaments in the hand or hand wrist
- •Being able to comprehend, sign, and date the written informed consent form (ICF)); and
- •Being able to visit the hospital to be examined the repaired region after the procedure.
排除标准
- •Having serious concomitant disease
- •Being pregnant
- •Having the control hand not suitable to serve as comparator
研究组 & 干预措施
SportWelding Fiji Anchor
Experimental
干预措施: SportWelding Fiji Anchor (Device)
结局指标
主要结局
Operation success
时间窗: Day 1
Technical success confirmed at the end of surgery by mean of an assessment form (e.g anchor insertion without breaking and suture without pulling off from the tissue during surgery).
Procedure success
时间窗: 12 weeks
No dislodged/broken anchor nor ruptured sutures observed at 2, 6 and 12 weeks post operative evaluation
次要结局
- Clinical function(3 and 6 months)
- Adverse events(From Day 1 to 12 months)
研究者
研究点 (1)
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