NCT03668717进行中（未招募）不适用
Survivorship and Outcomes of Robotic-Arm Assisted Medial Unicompartmental Knee Arthroplasty
St. Helena Hospital Coon Joint Replacement Institute1 个研究点 分布在 1 个国家目标入组 133 人开始时间: 2011年10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
- 133
- 试验地点
- 1
- 主要终点
- % of patients with revisions
研究概览
简要总结
The purpose of the study is to determine the survivorship of robotic-arm assisted MCK medial onlay Unicompartmental knee arthroplasty implants at two, five and tem year follow up.
详细描述
The purpose of the study is to determine the survivorship of robotic-arm assisted MCK medial onlay unicompartmental knee arthroplasty implants at two, five, and ten year follow up. Study participants will also be asked about their level of satisfaction with their knee function following their robotic-arm assisted Unicompartmental Arthroplasty.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
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 underwent primary robotic-arm assisted unicompartmental arthroplasty and received a medial MCK onlay implant and are at least 24 months post-operative.
- •Patient has signed an IRB approved Informed Consent Form or with IRB approved waiver of written consent, patient has verbally consented to study participations.
- •Patient willing to comply with follow up.
排除标准
- •Patient will be excluded from participation in the study if they are cognitively unable to answer questions related to their index procedure and health related quality of life forms.
- •Patient had active infection
- •Medial MCK onlay implants were implanted without bone cement
- •Patients did not have sufficient bone stock to allow for insertion and fixation of components
- •Patient did not have sufficient soft tissue integrity to allow for stability
- •Patient had a neurological or muscular deformity that did not allow for control of the knee.
结局指标
主要结局
% of patients with revisions
时间窗: 10 year after surgery
To determine the revision rate in this patient population
次要结局
- % of patients with revisions(2 years after surgery)
研究者
研究点 (1)
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