NCT03505580终止不适用
Etude rétrospective et Prospective, Multicentrique, Non contrôlée, Non randomisée, Ouverte évaluant la Performance et la sécurité de l'Implant AMIStem
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Presence of radiolucencies
研究概览
简要总结
The purpose of this study is to evaluate radiological performance of the cementless femoral stem AMIStem H at 1 and 5-year follow-up.
All the patients operated at the investigational sites between April 2009 and April 2012 will be reviewed at 1, 5 and 10 year according to standard practice
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
- •patients who underwent total hip arthroplasty at the investigational sites between April 2009 and April 2012
- •patients bearing an AMIStem-H cementless femoral stem
排除标准
- •patients who refuse to give consent for the treatment of data
结局指标
主要结局
Presence of radiolucencies
时间窗: 5 years
次要结局
- evaluation of radiolucent lines progression(5 years, 10 years)
- Record of adverse events(1, 5 years and 10 years)
- correlation between the presence of radiolucencies and patient/implant characteristics(5 years, 10 years)
研究者
研究点 (2)
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