International, Prospective, Longterm Study Comparing the Clinical Outcome and In-vivo Wear Behaviour of AS Coated Versus Uncoated Columbus® Total Knee Prosthesis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Aesculap AG
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Polyethylene wear over time
研究概览
简要总结
This clinical study is a Post-Market Clinical Follow-Up (PMCF) measure and is aiming to compare the in-vivo wear behaviour of the Columbus® total knee prosthesis between the standard Cobalt Chromium (CoCr) and the multilayer coated so called "Advanced Surface" (AS) of the same implant. The clinical investigation is designed as a International, prospective, longterm non-interventional study in order to gain clinical data of many patients within the routine clinical application of the investigational device.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Indication for a primary bicondylar total knee endoprosthesis with the Columbus® DD knee prosthesis
- •Written signed informed consent of patient
- •Willingness and mental ability to participate at the long-term follow-up examinations
排除标准
- •Pregnancy
- •Patient age <45 and >75years
- •Acute inflammatory arthritis
- •Coagulation disorders (e.g. Haemophilia)
结局指标
主要结局
Polyethylene wear over time
时间窗: until 10 years postoperatively
The in-vivo wear of the Polyethylene (PE) tibial tray will be assessed using the observer independent method of the imaging core lab. The PE wear assessment is based on the absolute object position of the knee prosthesis over time.
次要结局
- Progress of Clinical Outcome [Oxford Knee Score] compared to baseline(preoperatively and 3 months, 12 months, 2 years, 5 years, 10 years postoperatively)
- Radiographic comparison of alignment over time(baseline (assessed at discharge from hospital up to 10 days postoperatively); 3 months; 12 months; 5 years; 10 years)
- Quality of Life [EQ-5D-5L] compared to baseline(preoperatively and 3 months, 12 months, 2 years, 5 years, 10 years postoperatively)
- Implant survival(until 10 years postoperatively)
- Progress of Clinical Outcome (Forgotten Joint Score-12) over follow-up period(3 months, 12 months, 2 years, 5 years, 10 years postoperatively)
- Radiographic comparison of tibial slope over time(baseline (assessed at discharge from hospital up to 10 days postoperatively); 3 months; 12 months; 5 years; 10 years)
- Adverse events / serious adverse events(During the course of the study up to 10 years postoperatively)
- Number of Participants with radiological complications over time(During the course of the study up to 10 years postoperatively)
- Radiographic comparison of implant migration over time(baseline (assessed at discharge from hospital up to 10 days postoperatively); 3 months; 12 months; 5 years; 10 years)
- Radiographic comparison of the joint line over time(baseline (assessed at discharge from hospital up to 10 days postoperatively); 3 months; 12 months; 5 years; 10 years)
- Biomechanical analysis of retrievals in case of revision(During the course of the study up to 10 years postoperatively)