NCT02230826招募中不适用
Multicentric Observational PMCF Study to Evaluate Long-term Outcome, Performance and Safety of Implantable Devices in Hip Arthroplasty
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Corin
- 入组人数
- 2,500
- 试验地点
- 25
- 主要终点
- Evaluation of long-term outcome after hip arthroplasty with Corin implants.
研究概览
简要总结
This long-term outcomes study is designed to collect safety and efficacy data on designated, commercially available, hip arthroplasty products.
详细描述
Outcome data collected from this study will be used for Post Market Surveillance (PMS) and Clinical Evaluations on Corin hip devices and will support peer-reviewed publications on products performance and safety at long term follow-up.
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
- •Man or woman >18 years
- •Subjects with indication of arthroplasty surgery with Corin hip devices which are under assessment as part of this PMCF study
- •Subjects who agreed for study participation.
排除标准
- •Subjects with existing tumour and/or particularly high surgical risk-
- •Subjects with anaesthetic risk class IV or higher
- •Subjects under guardianship and/or unable to follow procedures or matters related to the study (examples: Illiterate, recent psychotic or mania disorders and / or inability to comply with usual follow-up visits.)
- •Contraindications for arthroplasty with a Corin hip devices as per product IFU
研究组 & 干预措施
Patients with Hip arthroplasty
Patients with Hip implants.
结局指标
主要结局
Evaluation of long-term outcome after hip arthroplasty with Corin implants.
时间窗: At 10 years
Implants revision rate at 10-year FU hip arthroplasty
次要结局
- Evaluation of patient quality of life(starting intraoperatively up to 20-year FU)
- Evaluation of long-term outcome after hip arthroplasty with Corin implants at 15 and 20-year FU.(at 15- and 20-year)
- Evaluation of patient satisfaction following surgery(3 months ; 2.5-year; 6, 11, 15, 20-year visits)
- Radiological evaluation of positioning and osteointegration of Corin hip implants.(starting intraoperatively up to 20-year FU)
- Evaluation of clinical performance of Corin hip implants(starting intraoperatively up to 20-year FU)
- Evaluation of Safety of Corin hip implants(starting intraoperatively up to 20-year FU)
研究者
研究点 (25)
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