NCT03782298已完成不适用
Safety and Performance of PEEK Anchors (Dynomite, Spyromite, Raptormite, Footprint Ultra PK SL) in Extremities
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 4
- 主要终点
- Number of Participants With Clinical Success of the Study Devices in the Extremity Over a Time Period of 6 Months After Intervention
研究概览
简要总结
Safety and performance of the study devices in extremities over a time period of 6 months after intervention.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who have undergone extremity joint repair using the study devices.
- •Subjects aged 18 years and older at the time of surgery.
排除标准
- •Subject is entered in another investigational drug, biologic, or device study or has been treated with an investigational product within 12 months post-operative.
- •Subjects who are < 3 months post-operative
结局指标
主要结局
Number of Participants With Clinical Success of the Study Devices in the Extremity Over a Time Period of 6 Months After Intervention
时间窗: 6 months
Clinical success was defined as extremity repairs without signs of device failure and/or re-intervention as assessed by the surgeon. Specifically, clinical success was considered "Yes" based on the following 3 main criteria: * no inflammatory or allergic response * no device-related adverse event (AE) * no device deficiencies (DDs) leading to revision surgery (re intervention) on the index extremity
次要结局
- Number of Participants With Clinical Success of the Study Devices in the Extremity Over a Time Period of 12 Months After Intervention(12 months)
研究者
研究点 (4)
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