NCT03668691进行中(未招募)不适用
Clinical Outcomes of Joint Arthroplasty
St. Helena Hospital Coon Joint Replacement Institute1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2011年7月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- % of patients with Revisions
研究概览
简要总结
The purpose of this study is to document the clinical outcomes of partial knee replacement surgery using robotic-arm assisted knee joint surgery at 3 weeks, 6 weeks, 12 weeks, 6 months, 1 year, 2 years, 5 years and 10 years post operative.
详细描述
The purpose of this study is to document the clinical outcomes of partial knee replacement surgery using robotic-arm assisted knee joint surgery at 3 weeks, 6 weeks, 12 weeks, 6 months, 1 year, 2 years, 5 years and 10 years post operative.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •All patients over 21 years of age who require a primary robotic-arm assisted unicompartmental knee arthroplasty or bicompartmental knee arthroplasty. These patients will have failed non-operative management of their joint disease and are candidates for partial joint replacement because of pain and stiffness that interferes with their performances or normal daily activities.
排除标准
- •Patient had an active infection
- •Onlay implants were implanted without bone cement
- •Patient does not have enough bone stock to allow for insertion and fixation of the components
- •Patient does not have sufficient soft tissue integrity to allow for stability
- •Patient has a neurological or muscular deformity that did not allow for control of the knee
- •Patient will be excluded from participation in the study if they are cognitively unable to answer study questions
- •Pregnant women are excluded.
结局指标
主要结局
% of patients with Revisions
时间窗: 10 years after surgery
To assess the revision rate of this patient population
次要结局
- Patient satisfaction rate(10 years after surgery)
研究者
研究点 (1)
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