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1日最近更新: 2012年12月20日

适应症

干预措施

试验速览

阶段: 4 期
发起方: Seoul National University Hospital
入组人数: 80
试验地点: 1
主要终点: Rotational Angle Between Femur and Tibia

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

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: 否

入选标准

•primary total knee arthroplasty

排除标准

•infection
•severe deformity in knee

研究组 & 干预措施

Mobile bearing

Active Comparator

Mobile bearing type between polyethylene insert and tibial component MB type will be randomly used in total knee arthroplasty

干预措施: Mobile bearing (Device)

Fixed bearing

Active Comparator

Fixed bearing type between polyethylene insert and tibial component FB type will be randomly used in total knee arthroplasty

干预措施: Fixed bearing (Device)

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

发起方

Seoul National University Hospital

申办方类型

Other

责任方

Sponsor

研究点 (1)

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