Ambispective Study to Assess the Safety and the Performance of SAGITTA EVL R Stem
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Survival rate at mid/long term follow-up
研究概览
简要总结
This clinical study is conducted to collect data on hip arthroplasty with the SAGITTA EVL-R revision femoral stems manufactured by SERF.
This study will confirm the performance and safety of the SAGITTA EVL R revision femoral stems within the framework of MDR 2017/745 and in relation to the recommendations of the MEDDEV guide 2.7.1. Rev 4 (Clinical Evaluation Guide), which provides for a systematic procedure to monitor clinical data in order to verify the claimed performance of medical devices.
The primary objective is to evaluate the long-term survival rate (7 to 10 years post-op +/- 2 years) of SAGITTA EVL R stems.
Secondary objectives are to :
- study long term patient satisfaction with their hip prosthesis,
- confirm the long-term safety of these implants by studying the possible complications observed,
- evaluate the performance of these implants using clinical scores.
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 over 18 years old at the time of surgery,
- •Patient implanted with a SAGITTA EVL R revision femoral stem within its indications between 01/01/2010 and 31/12/2015,
- •Affiliated to French health insurance system
排除标准
- •Patient who has rejected to the use of his/her personal data,
- •Patient unable to understand the surgeon's instructions or to carry out the post-operative follow-up.
结局指标
主要结局
Survival rate at mid/long term follow-up
时间窗: At 7/10 years after surgery
Assess the survival rate at 7/10 year-follow-up, whatever the cause of revision
Survival Rate at Mid/Long Term Follow-up
时间窗: At 7/10 years after surgery
Assess the survival rate at 7/10 year-follow-up, whatever the cause of revision
次要结局
- Oblivion of prosthesis(At 7/10 years after surgery)
- Pain release(At 7/10 years after surgery)
- Patient's satisfaction(At 7/10 years after surgery)
- Adverse events(At 7/10 years after surgery)
- Functional improvement(At 7/10 years after surgery)
- Patient's Satisfaction(At 7/10 years after surgery)
- Adverse Events(At 7/10 years after surgery)
- Oblivion of Prosthesis(At 7/10 years after surgery)
- Absence of Squeaking(At 7/10 years after surgery)
- Functional Improvement(At 7/10 years after surgery)