NCT01705366终止不适用
Clinical Outcomes of Joint Arthroplasty
Northwest Surgical Specialists, Vancouver1 个研究点 分布在 1 个国家目标入组 316 人开始时间: 2012年10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
- 316
- 试验地点
- 1
- 主要终点
- Survivorship of Components
研究概览
简要总结
The objective of this study is to document the demographic and clinical characteristics and the long-term clinical outcomes of patients who require a robot assisted knee arthroplasty.
The hypothesis is that MAKO® robot assisted surgery replacing one or two compartments of the knee joint has 10 year implant survival and clinical outcomes that are equivalent to other knee replacement systems.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •requires either primary or revision knee replacement surgery because of pain and joint stiffness that interferes with performance of normal daily activities
- •has failed non-operative management of their joint disease
排除标准
- •cognitively unable to complete study health-related quality of life forms
- •pregnant women
结局指标
主要结局
Survivorship of Components
时间窗: 10 years
Survivorship of components is defined as knee implant device(s) remaining in patient.
次要结局
- American Knee Society Knee Score(1-2 weeks prior to surgery, 1-2 weeks after surgery, 4-6 weeks after surgery, 10-12 weeks after surgery, 6 months after surgery, 1 year, 2 years, 5 years, and 10 years after surgery)
研究者
研究点 (1)
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