Ambispective Study Evaluating the Clinical Results of SAGITTA EVL R Revision Stems
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Survival Rate at Mid 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. In order to reflect current practice, a comprehensive and continuous series of patients will be included.
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.
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 01/01/2016 and 31/12/2018,
- •Affiliated to French health insurance system
排除标准
- •Patient who has not expressed consent for data collection and participation in the study,
- •Patient unable to understand the surgeon's instructions or to perform postoperative follow-up.
- •Patient with a contraindication to the use of the SAGITTA EVL R revision femoral stem
- •Patient implanted with a SAGITTA EVL R revision femoral stem outside its indication
结局指标
主要结局
Survival Rate at Mid Term Follow-up
时间窗: Between 4 to 7 years after surgery
Assess the survival rate, at least 4 year-follow-up, whatever the cause of revision. Cumulative survival rate expressed in percentage of implants not revised (remaining in place) using Kaplan Meier calculation.
次要结局
- Adverse Events(From per operative period to 4/6 years after surgery)
- Survival Rates at Mid Term Follow-up (by Component)(At 4/6 years after surgery)
- Survival Rates at Mid Term Follow-up (by Etiology)(At 4/6 years after surgery)
- Patient's Satisfaction(At 4/6 years after surgery)
- Oblivion of Prosthesis(At 4/6 years after surgery)
- Functional Improvement(At 4/6 years after surgery)