A Prospective, Observational, Monocentre 5-year Follow-up Clinical Trial on a Historical Consecutive Cohort of Unicompartmental Knee Arthroplasty Patients Treated With the Mobile Bearing Unicondylar Knee Prosthesis Univation XM
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Aesculap AG
- 试验地点
- 1
- 主要终点
- Survival Rate of the Implant
研究概览
简要总结
The study is set up due to regulatory purposes and to collect routine clinical data of the mobile-bearing implant univation XM. The study is designed as a prospective follow-up study with a historic patient cohort who have been treated with the product under investigation two years ago. This design is selected to quicker realize follow-up data as patients have already been treated in the past.
As the mobile version of the implant is not widely used, the study will be set up as a monocentric study in France. The clinical hypothesis of the study is that patients who are treated with the product under investigation have a similar outcome and survival rate in comparison to other established unicondylar knee systems on the market. Comparison for the later evaluation will be taken out of recent orthopaedic registries.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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 has received a primary mobile bearing UKA at the study site between January 2017 and December 2018 using the product under investigation
- •Patient's written consent and willingness to participate at the clinical study and the follow-up examinations
排除标准
- •Pregnancy
- •Patient Age <18 years at the time of the surgery
结局指标
主要结局
Survival Rate of the Implant
时间窗: 5 years after surgery
Revision-free survival rate after 5 years according to Kaplan-Meier
次要结局
- Development of Knee joint function(in the postoperative course, up to 5 years after surgery)
- Development of Oxford Knee Score(in the postoperative course, up to 5 years after surgery)
- Intraoperative/surgery Data(intraoperative)
- Radiographic evaluation(in the postoperative course, up to 5 years after surgery)
- Rate of Serious Adverse Events(in the postoperative course, up to 5 years after surgery)