跳至主要内容
临床试验/NCT03668756
NCT03668756已完成不适用

Comparison of Computer-Assisted Navigation and Conventional Instrumentation for Bilateral Total Knee Arthroplasty: The Functional Outcome of Mid-Term Follow-up Study

Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2017年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
56
试验地点
1
主要终点
International Knee Society (IKS)

研究概览

简要总结

To compare the functional outcomes of Computer-Assisted Navigation (CAS) and Conventional Instrumentation TKA at the 8-year follow-up.

详细描述

The data of the present study was collected from the review of the medical chart of the patients who were scheduled to undergo staged bilateral TKA and randomly assigned to receive Computer-Assisted Navigation (CAS) TKA in one limb and conventional TKA. Then, comparing the functional outcomes of CAS and Conventional Instrumentation was performed by statistical software.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • The patients who were scheduled to undergo staged bilateral TKA and randomly assigned to receive CAS TKA in one limb and conventional TKA in the other at the 8-year follow-up.

排除标准

  • 未提供

结局指标

主要结局

International Knee Society (IKS)

时间窗: up to 8-year follow-up

To assess the functional outcome of TKA by self-explanatory questionnaire

次要结局

  • Hospital for Special Surgery (HSS) Questionnaire(Baseline, 8-year follow-up)
  • Western Ontario and McMaster University Osteoarthritis Index (WOMAC)(Baseline, 8-year follow-up)
  • Short Form-36 (SF-36) Health Survey(Baseline, 8-year follow-up)
  • Radiographic evaluation(Baseline and 3 months after operation)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Comparison of Computer-Assisted Navigation and... | 临床试验