NCT05810285已完成不适用
Total Knee Arthroplasty With Vitamin E Polyethylene
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 186
- 试验地点
- 1
- 主要终点
- Implant Survival for Aseptic Loosening
研究概览
简要总结
The aim of this observational study is to investigate if there is any difference in survival rate, clinical and radiological results after total knee replacement with vitamin E-blended polyethylene in comparison to conventional polyethylene at minimum 7-year follow-up
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient who received primary cemented total knee arthroplasty with GKS Prime Flex Mobile knee by Permedica Orthopaedics with vitamin E polyethylene bearing or with conventional polyethylene bearing.
- •Minimum 7-year follow-up;
- •Age ≥ 18 and < 85 years;
- •Patient who signed informed consent.
排除标准
- •Patient who received primary cemented total knee arthroplasty with a different knee prosthetic design;
- •Patient already enrolled in other clinical studies.
结局指标
主要结局
Implant Survival for Aseptic Loosening
时间窗: 10-year follow-up
Kaplan-Meier cumulative survival with revision due to aseptic loosening as the end-point
次要结局
- Implant Survival for Any Reason(10-year follow-up)
- Forgotten Joint Score (FJS-12)(At mean follow-up of 8.5 years and 8.3 years for Vitamin E and Polyethylene, respectively)
- American Knee Society Score (KSS)(At mean follow-up of 8.5 years and 8.3 years for Vitamin E and Polyethylene, respectively)
- Periprosthetic Radiolucent Line(At mean follow-up of 8.5 years and 8.3 years for Vitamin E and Polyethylene, respectively)
- Periprosthetic Osteolysis(At mean follow-up of 8.5 years and 8.3 years for Vitamin E and Polyethylene, respectively)
研究者
研究点 (1)
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