NCT00351793已完成不适用
A Clinical Trial Follow-up Study of the Genesis II Posterior Stabilized Total Knee Replacement
Ross Leighton1 个研究点 分布在 1 个国家目标入组 186 人开始时间: 2003年1月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 186
- 试验地点
- 1
- 主要终点
- Effectiveness and Safety
研究概览
简要总结
The purpose of this study is to look at the outcomes of the GENESIS II Posterior Stabilized Total Knee Replacement.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A combined deformity of <30 degrees = group 1
- •A combined deformity of >30 degrees = group 2
- •Patient is willing to consent to participate in the study
- •Patient is available for follow-up through at least 2 years but preferably 5 years
- •Patient has met acceptable preoperative medical clearance and is free of or treated for medical conditions that would pose excessive operative risk
- •Patients who are fluent in English and are able to understand their role in a clinical trial
排除标准
- •Active, local infection or systemic infection
- •Fibromyalgia patients
- •Patients whom, as judged by the surgeon, are not capable of understanding the informed consent or the requirements of the protocol and or are reasonably unlikely to be compliant with the prescribed routine and the follow-up evaluation schedule
结局指标
主要结局
Effectiveness and Safety
时间窗: 5 years
Will evaluate effectiveness and safety during a 5 year period via analysis of the Knee Society Score, revision status, and radiographic evaluation
次要结局
- Western Ontario and MacMaster Universities Osteoarthritis Index (WOMAC)(Pre-op, 6 months, 1 year, 2 years, 5 years)
- Knee Society Clinical Rating(Pre-op, 6 months, 1 year, 2 years, 5 years)
研究者
Ross Leighton
Orthopedic Surgeon
Nova Scotia Health Authority
研究点 (1)
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