NCT02047955终止不适用
Tornier Shoulder Outcomes Clinical Study
Stryker Trauma and Extremities15 个研究点 分布在 1 个国家目标入组 7,500 人开始时间: 2014年3月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 7,500
- 试验地点
- 15
- 主要终点
- Number of device associated and procedure associated adverse events
研究概览
简要总结
The Tornier Shoulder Outcomes Study is designed to collect safety and efficacy data on designated commercially available Tornier Shoulder repair products. In addition, this study will provide performance data for use in education, marketing materials, peer-reviewed publications and support research and development of future products.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •18 years or older
- •Willing and able to comply with the requirements of the study protocol
- •Considered for treatment with one or more Tornier shoulder arthroplasty or fracture devices included in this study
排除标准
- •Patients who are not able to comply with the study procedures based on the judgment of the assessor will be excluded (e.g. cannot comprehend study questions, inability to keep scheduled assessment times)
结局指标
主要结局
Number of device associated and procedure associated adverse events
时间窗: up to 10 years
Adverse events will be evaluated from inclusion to last follow-up and will be documented during the study and categorized as whether they are serious and whether they are related to the Sponsor device or implant procedure.
次要结局
- Rates of reoperation and revision surgery(up to 10 years)
研究者
研究点 (15)
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