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临床试验/NCT01027819
NCT01027819Unknown4 期

Comparison of Outcomes in Mobile and Fixed-bearing Total Knee Arthroplasty

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2009年11月最近更新:
适应症

试验速览

阶段
4 期
入组人数
80
试验地点
1
主要终点
Rotational Angle Between Femur and Tibia

研究概览

简要总结

The purpose of this study is to compare the clinical and radiological outcomes of mobile-bearing with that of fixed-bearing in total knee arthroplasty.

详细描述

Double blind, randomized prospective study Mobile or fixed bearing of the same company

  • Mobile bearing group : group M
  • Fixed bearing group : group F

Inclusion criteria

  • patients expected primary total knee arthroplasty without severe deformity

Clinical outcomes

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • primary total knee arthroplasty

排除标准

  • infection
  • severe deformity in knee

结局指标

主要结局

Rotational Angle Between Femur and Tibia

时间窗: 2 weeks

次要结局

  • Knee Society Score(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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