Ambispective Open Multicentric Study Evaluating Clinical Results of Unicondylar Knee Arthroplasty Performed With U-Knee/Uni-Kroma Implants
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Survival rate
研究概览
简要总结
This clinical investigation was led as a post-market clinical follow-up study (post-market device development stage).The main objective of this study is to collect short- and medium-term clinical data on the unicondylar knee prosthesis U-Knee / Uni-Kroma, in order to evaluate the performance of these implants.
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
- •- All patients using a U-Knee / Uni-Kroma unicompartmental knee prosthesis and benefiting from the social security affiliation scheme.
排除标准
- •Patients who objected to participating in the study and the processing of their data
- •Patients unable to understand the surgeon's instructions to complete their questionnaires or perform postoperative follow-up
- •Patients who already have a unicompartmental prosthesis on the knee in question that need to be revised.
研究组 & 干预措施
Fixed cementless UKP
Patient implanted with a fixed cementless Unicompartmental prosthesis
干预措施: Unicompartmental knee arthroplasty (Device)
Fixed cemented UKP
Patient implanted with a fixed cemented Unicompartmental prosthesis
干预措施: Unicompartmental knee arthroplasty (Device)
Mobile Cementless UKP
Patient implanted with a mobile cementless Unicompartmental prosthesis
干预措施: Unicompartmental knee arthroplasty (Device)
Mobile Cemented UKP
Patient implanted with a mobile cemented Unicompartmental prosthesis
干预措施: Unicompartmental knee arthroplasty (Device)
Fixed Cementless UKP (TIT coating)
Patient implanted with a fixed cementless Unicompartmental prosthesis coating with "TIT"
干预措施: Unicompartmental knee arthroplasty (Device)
结局指标
主要结局
Survival rate
时间窗: 5 years
Assess the survival rate of the investigational medical devices at 5 year follow-up
次要结局
- Functional improvement(From pre-operative to 10 years)
- Activity(From pre-operative to 10 years)
- Survival rate(12-18 months to 10 years)
- Forgetfulness of prosthesis(From pre-operative to 10 years)