NCT02319291已完成不适用
Outcomes of Total Knee Arthroplasty (TKA) Using the Sigma PS150 Primary Total Knee System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 175
- 试验地点
- 4
- 主要终点
- Implant Survivorship
研究概览
简要总结
This registry is intended to evaluate the clinical outcomes of the DePuy P.F.C. Sigma PS150 RP Total Knee System. 200 participants will be enrolled prospectively or retrospectively and the follow up period will be 5 years. Data collection will include Radiographic Analysis, Knee Society Evaluation and Adverse Events.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary total knee replacement for any indication in accordance with the Instructions For Use accompanying the SIGMA PS150 implant.
- •Signed Informed Patient Consent
排除标准
- •There are no exclusion criteria for this registry.
结局指标
主要结局
Implant Survivorship
时间窗: 5 years
Lack of revision with revision meaning no removal or replacement of any TKA component.
次要结局
- Flexion(1, 3 & 5 years)
- Knee Society Score - Function(1, 3 & 5 years)
- Knee Society Score - Knee Score(1, 3 & 5 years)
- Extension(1, 3 & 5 years)
- Adverse Events(1, 3 & 5 years)
- Pain sub-question of the Knee Society Score(1, 3 & 5 years)
- Radiographic Analysis(1, 3 & 5 years)
研究者
研究点 (4)
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