NCT04997005进行中（未招募）不适用
Prospective, Multicentre, Open Study Evaluating the Performance and Stability of the AMIStem-P Femoral Stem
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 550
- 试验地点
- 5
- 主要终点
- Survival rate
研究概览
简要总结
This is a Post-Market Surveillance study of AMIStem-P femoral stem prosthesis
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a disease (primary coxarthrosis, inflammatory arthritis of the hip, necrosis of the femoral head, etc.) requiring a total hip replacement
- •Patient eligible to receive an uncemented AMIStem-P femoral stem
- •Patient agreeing to comply with the study requirements
- •Patient willing to provide written informed consent
- •Patient affiliated to a social security system
- •Patients between 18 and 85 years old
排除标准
- •Participation in biomedical research
- •Patients younger than 18 years old
- •Vulnerable adult patients according to article L1121-6 of the French Public Health Code
- •Pregnant or breastfeeding women
- •Patients unable to provide written informed consent
结局指标
主要结局
Survival rate
时间窗: 10 years
Kaplan Meier method
次要结局
- Harris Hip Score(3/6 months, 1, 3, 5 and 10 years)
- Oxford Hip Score(3/6 months, 1, 3, 5 and 10 years)
- Radiographic performance of the implants(3/6 months, 1, 3, 5 and 10 years)
- Quality of life - Euroqol questionnaire(3/6 months, 1, 3, 5 and 10 years)
- Adverse events(intraop, 3/6 months, 1, 3, 5 and 10 years)
研究者
研究点 (5)
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