NCT02934802招募中不适用
Non-Interventional Consecutive and Prospective Study of e.Motion® PS Pro Prosthesis in the Total Knee Artroplasty
BBraun Medical SAS1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2016年5月26日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Survival rate at 5 years of the e motion PS Pro
研究概览
简要总结
This post-market clinical follow-up study intends to investigate the survival rate at 5 years of the e.motion® PS Pro System.
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
- •Patient having signed informed consent
- •Patients over 18 for which a Total Knee Prosthesis with e.motion® PS Pro was decided
- •Patients willing to participate in a 5 years follow-up
排除标准
- •Active or suspected infection
- •Tumor on the concerned knee
- •Patient vulnerable and under legal protection
结局指标
主要结局
Survival rate at 5 years of the e motion PS Pro
时间窗: the survival rate will be evaluated 6-12 weeks; 1; 2; 3; 4 and 5 years after the knee arthroplasty
The endpoint is the revision of at least one of the prosthesis components. If a patient withdraws from the study for any reason, counts as the end date for the survival of the implant of the last day on which the implants were well known even in place.
次要结局
未报告次要终点
研究者
研究点 (1)
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