Migration and Survival of All-polyethylene Tibial All Poly Components Compared to the Metal-backed Modular Components of the Triathlon CS Total Knee System. A Single Center RSA Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Region Skane
- 入组人数
- 60
- 主要终点
- Migration, measured by means of RSA
研究概览
简要总结
The primary objective is the assessment of prosthetic migration results after two years of the Triathlon CS Knee System with all-polyethylene tibial components compared to the Triathlon CS Knee System with metal-backed modular components by means of Roentgen Stereophotogrammetry.
详细描述
The secondary objective will be the prediction of the long-term survival based on the two-year migration patterns combined with clinical factors and radiographic aspects. In order to identify other clinical parameters besides the fixation of the prosthesis components, clinical scores and radiographic aspects will be correlated with the RSA outcome. The 10 years results will be used to verify the predicted long-term survival results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Migration, measured by means of RSA
时间窗: 2 years
Migration (MTPM in mm) of the prosthesis with respect to the host bone measured by means of roentgen stereophotogrammetric analysis (RSA)
次要结局
- Migration, measured by means of RSA(10 years)
- Investigation of clinical performance and patient outcome with the Knee Society Score (KSS)(pre-operative, 3 months, 1, 2, 5, 7 and 10 years)
- Investigation of clinical performance and patient outcome with the Knee Injury and Osteoarthritis Outcome Score (KOOS) patient questionnaire(pre-operative, 3 months, 1, 2, 5, 7 and 10 years)
- Investigation of clinical performance and patient outcome with EuroQuol-5 dimension (EQ-5D) patient questionnaire(pre-operative, 3 months, 1, 2, 5, 7 and 10 years)
- Investigation of clinical performance and patient outcome with the Forgotten Joint Score (FJS) patient questionnaire.(pre-operative, 3 months, 1, 2, 5, 7 and 10 years)
- Investigation of patient outcome with radiographic analysis(pre-operative, 3 months, 1, 2, 5, 7 and 10 years)