NCT03814044已完成不适用
PMCF Study on PEEK Suture Anchors for Hip Indications
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 149
- 试验地点
- 4
- 主要终点
- Number of Participants With Clinical Success of the Study Devices in the Hip Over a Time Period of 6 Months After Intervention
研究概览
简要总结
Post-market clinical follow-up (PMCF) on the PEEK Suture Anchors in the hip.
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
- 否
入选标准
- •Subjects who have undergone hip joint repair using the study devices.
- •Subjects aged 18 years and older at the time of surgery.
- •Subjects who had a visit to their provider between 3 and 15 months postoperative.
排除标准
- •Subjects who are < 12 months post-operative.
- •Subject is entered in another investigational drug, biologic, or device study or has been treated with an investigational product within 30 days prior to surgery
- •Subject had off-label use of the PEEK suture anchor during surgery.
结局指标
主要结局
Number of Participants With Clinical Success of the Study Devices in the Hip Over a Time Period of 6 Months After Intervention
时间窗: 6 months
Clinical success was defined as hip repairs without signs of device failure and/or re-intervention as assessed by the surgeon (Yes/No). Specifically, clinical success was achieved with "Yes" responses 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 (reintervention) on the index hip
次要结局
- Number of Participants With Clinical Success of the Study Devices in the Hip Over a Time Period of 12 Months After Intervention(12 months)
- Visual Analog Scale (VAS) - Pain(6 and 12 months)
- Count of Participants With Range of Motion (ROM) Full Functional Arc(6 months and 12 months)
- Range of Motion (ROM)(6 and 12 months)
研究者
研究点 (4)
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