NCT02196818终止不适用
A Multi-centre, Prospective Post Marketing Surveillance Study to Assess Mid-term Performance of the Mpact Cup in Subjects Requiring Primary Total Hip Arthroplasty
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- The Kaplan-Meier analysis as a measure of implant performance.
研究概览
简要总结
This is a multi-centre, prospective post marketing surveillance study to assess mid-term performance of the Mpact cup in subjects requiring primary total hip arthroplasty.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to the patient's surgery.
- •Those presenting with disease that meets the indications for use for Medacta USA implants defined by this study (on-label use).
- •Patients must be willing to comply with the pre and post-operative evaluation schedule.
排除标准
- •Those with one or more medical conditions identified as a contraindication defined by the labeling on any Medacta implants used in this study.
结局指标
主要结局
The Kaplan-Meier analysis as a measure of implant performance.
时间窗: 5 years
次要结局
- Radiological analysis as a meausure of safety.(3/6 months, 1,2 and 5 years)
- The Harris Hip Score.(pre-op, 3/6 months, 1,2 and 5 years)
研究者
研究点 (4)
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