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临床试验/NCT03668691
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

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

发起方
St. Helena Hospital Coon Joint Replacement Institute
申办方类型
Other
责任方
Sponsor

研究点 (1)

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