NCT05142462进行中（未招募）不适用
Post Market Clinical Follow-up of EUROSCUP Fixe Acetabular Cup
EUROS4 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2021年10月27日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- Safety of EUROSCUP Fixe
研究概览
简要总结
EUROSCUP Fixe is intended for use in primary and revision total hip replacement surgery.
Hip replacement is intended to provide increased patient mobility and reduce pain by replacing the damages hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.
As part of post market vigilance, EUROS will collect data on EUROSCUP Fixe performances and safety
详细描述
Post market observational study. This study is retropective and prospective, non comparative.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient who received EUROSCUP Fixe.
- •Patient informed of its participation to the study
- •Patient aged between 18 and 80 years old (<80).
排除标准
- •Patient presenting a contraindication to EUROSCUP Fixe implantation.
- •Patient who refused to participate to the study
- •Vulnerable subjects
结局指标
主要结局
Safety of EUROSCUP Fixe
时间窗: 1 year
Collect the safety of the device trought complications occurence rate
次要结局
- Radiological performances of EUROSCUP Fixe(1 year)
- Survival of EUROSCUP Fixe(10 years)
- Clinical performances of EUROSCUP Fixe(1 year)
研究者
研究点 (4)
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