NCT03594071已完成不适用
Safety and Performance of Q-Fix™ All-Suture Anchor System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 294
- 试验地点
- 5
- 主要终点
- Clinical Success Rate, Defined as Participant Joints Without Reintervention at 6 Months Post-operative, as Assessed by the Surgeon
研究概览
简要总结
Post-market clinical follow-up needed to address existing clinical data and gaps on the existing Q-Fix™ device and meet existing MDD/MEDDEV requirements
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject has undergone arthroscopic or open soft tissue repair with Q-Fix™ All-Suture Anchor System
- •Subject was ≥ 13 of age at time of surgery
排除标准
- •Subject is ≤ 6 months post-operative
- •Subject is entered in another investigational drug, biologic, or device study or has been treated with an investigational product within 12 months post-operative.
结局指标
主要结局
Clinical Success Rate, Defined as Participant Joints Without Reintervention at 6 Months Post-operative, as Assessed by the Surgeon
时间窗: 6 months
All individuals for whom the outcome of re-intervention is known at 6 months
次要结局
- Hip Visual Analog Scale (VAS) - Pain(Screening, 6 months, and 12 months)
- Shoulder Visual Analog Scale (VAS) - Pain(Screening, 6 months, and 12 months)
- Shoulder Range of Motion (ROM)(Screening, 6 months, and 12 months)
- Clinical Success Rate, Defined as Participant Joints Without Reintervention at 12 Months Post-operative, as Assessed by the Surgeon(12 months)
- Hip Range of Motion (ROM)(Screening, 6 months, and 12 months)
- Knee Range of Motion (ROM)(Screening, 6 months, and 12 months)
- Knee Visual Analog Scale (VAS) - Pain(Screening, 6 months, and 12 months)
研究者
研究点 (5)
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