NCT00698854进行中（未招募）不适用
A Prospective, Non-controlled, Clinical Investigation of the Vanguard™ Complete Knee System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 600
- 试验地点
- 8
- 主要终点
- KSS
研究概览
简要总结
The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of the Vanguard™ Complete Knee System.
详细描述
This is a 10-year prospective observational data collection on the Vanguard Total Knee system. Patients are asked to come in for a preop, operative, immediate post-operative, 6 Month, 1 Year, 3 Year,5 Year, 7 year, and 10 year visits to check on the function, range of motion, and radiographic assessment of their total knee device.
The Vanguard Knee is an FDA cleared device, and has been on the market since 2004.
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
KSS
时间窗: 10 year
Knee Society Score Assessment
次要结局
- Radiographic Information(10 years)
- Survivorship(10 years)
研究者
研究点 (8)
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