A Prospective Observational 5 Year Follow-up on a Historical Consecutive Cohort of 100 Primary Total Knee Arthroplasty (TKA) Cases Treated With the Posterior-stabilized VEGA System® PS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Aesculap AG
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Revision (non-survival) rate
研究概览
简要总结
Voluntary Post-Marketing Clinical Follow-up (PMCF) as part of the post marketing surveillance plan for the product under investigation.
For this PMCF only CE-marked medical devices have been used and will be used within their intended purpose and no additional invasive or other stressful examinations have been or are to be carried out (acc. to MPG §23b).
详细描述
This non-interventional clinical study (NIS) is conducted to clinically confirm the safety and performance of the Aesculap® VEGA System® PS components under routine conditions. The VEGA System® PS is an established TKA design, and there is a long-lasting experience in the use of PS components in particular; thus a NIS is thought to be sufficient to give the required confirmation. For this NIS only CE-marked medical devices have been used and will be used within their intended purpose and no additional invasive or other stressful examinations have been and are to be carried out (acc. to MPG §23b). This voluntary NIS is part of the post-marketing surveillance for the product under investigation.
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
- •Patient has received primary TKA at the study site five to six years ago using the product under investigation because of the following severe knee joint conditions that could not be treated through other therapies:
- •degenerative osteoarthritis,
- •rheumatoid arthritis,
- •posttraumatic arthritis,
- •symptomatic knee instability, knee stiffness or deformation of the knee joint
- •Age at the time of surgery ≥ 18 years
- •Patient signed informed consent
排除标准
- •Age younger than 18 years at the time of surgery
- •Any prior joint replacement at the index knee
- •Patient did not sign informed consent
- •All cases not listed under indications (according to IfU)
- •All cases showing any contraindication (according to IfU)
结局指标
主要结局
Revision (non-survival) rate
时间窗: 5 years
The objective of the study is to collect clinical 5 year outcome information on the product under investigation when used in routine clinical practice.
次要结局
- Knee injury and Osteoarthritis Outcome Score (KOOS)(5 years)
- Physical Component Summary (PCS-12) of SF-12® Health Survey (SF-12)(5 years)
- Pain(5 years)
- Mental Component Summary (MCS-12) of SF-12® Health Survey (SF-12)(5 years)
- Knee Score (KS) of Knee Society Score (KSS)(5 years)
- Functional Score (FS) of Knee Society Score (KSS)(5 years)