NCT01274546已完成不适用
A Long-term, Multicenter Follow Up Study of the Cruciate-retaining Foundation Knee System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Survivorship of the Device
研究概览
简要总结
The purpose of this study is to obtain long-term (10+ yrs) clinical and patient outcomes data on patients who received the cruciate-retaining Foundation Knee system during or prior to the year 2000.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject must have received a cruciate-retaining Foundation Knee system during or prior to the year
- •Surgery must have been a primary knee replacement.
- •Subject must have received only one primary knee replacement per hospitalization
- •Subject must have had a primary diagnosis of osteoarthritis of the operative knee.
- •Subject is able and willing to sign the informed consent document
排除标准
- •Subject must not have had any previous knee implants (unicondylar or total joint replacements)
- •Subject has a mental condition that may interfere with the subject's ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the Subject cannot understand the informed consent process, global dementia, prior strokes that interfere with the Subject's cognitive abilities, senile dementia, and Alzheimer's Disease)
- •Subject is a prisoner
结局指标
主要结局
Survivorship of the Device
时间窗: Single visit
The subject meets the inclusion/exclusion of the study and has a Foundation Knee that has survived without revision to date.
次要结局
- WOMAC Osteoarthritis Index(Single visit)
- Knee Society Score Evaluation(Single visit)
- Short Form - 36(Single Visit)
- Oxford Knee Score Assessment(Single visit)
- Range of Motion(Single visit)
- Radiographic failure(Single visit)
研究者
研究点 (1)
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