NCT01768871终止不适用
Prospective, Long-Term, Multi-Center Study on the Efficacy of the VEGA System® for Total Knee Arthroplasty.
Aesculap Implant Systems3 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2013年1月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 3
- 主要终点
- WOMAC
研究概览
简要总结
The primary objective of this study is to evaluate the function of the knee after a total knee replacement with the VEGA system®.
详细描述
To evaluate patients after total knee arthroplasty in terms of function for five years.
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
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •willing to sign the informed consent.
- •Patient has intact collateral ligaments.
排除标准
- •Inflammatory arthritis
- •Patients that have had a high tibial osteotomy or femoral osteotomy
- •Patients with neuromuscular or neurosensory deficiency which would make it difficult to assess the device performance.
结局指标
主要结局
WOMAC
时间窗: Two years
WOMAC function score 2 years post arthroplasty
次要结局
- Health related quality of life(Two years)
研究者
研究点 (3)
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