NCT03826667已完成不适用
Post-market Clinical Follow-up (PMCF) Study on PEEK Suture Anchors for Shoulder Indications
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 464
- 试验地点
- 11
- 主要终点
- Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 6 Months After Intervention
研究概览
简要总结
Post-market clinical follow-up on the PEEK Suture Anchors in the shoulder.
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 shoulder joint repair using the study devices.
- •Subjects aged 18 years and older at the time of surgery.
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.
结局指标
主要结局
Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 6 Months After Intervention
时间窗: 6 months
Clinical success was defined as shoulder 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 shoulder
次要结局
- Number of Participants With Clinical Success of the Study Devices in the Shoulder 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 and 12 months)
- Range of Motion (ROM)(6 and 12 months)
研究者
研究点 (11)
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