Observational Study of Shoulder Surgery Using FH ORTHO Medical Devices
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- FH ORTHO
- 入组人数
- 500
- 试验地点
- 3
- 主要终点
- Performance of the medical devices over long term follow-up (maximum10 years)
研究概览
简要总结
This study is a real-life observatory designed to collect long-term clinical data on patients who have undergone shoulder joint replacement or repair following shoulder trauma.
In this type of intervention, one or more medical devices distributed by FH ORTHO SAS may be used by surgeons.
This study meets the requirement for post-market clinical follow-up (PMCF) as defined in the European Medical Device Regulation (MDR 2017/745).
It therefore involves collecting in real life, i.e. under the usual conditions of surgery and short and long-term patient follow-up, minimal clinical data that will make it possible to document the continued benefit/risk of the medical devices concerned.
This study is designed as a permanent long-term observatory, of a non-interventional nature, with the objective of having long-term follow-up data (5 to 10 years depending on the devices concerned) for a maximum number of patients included.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Performance of the medical devices over long term follow-up (maximum10 years)
时间窗: maximum 10 years
Functional performance measured by the Constant-Murley score
次要结局
- revision rate medical devices over long term follow-up (maximum10 years)(maximum 10 years)
