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临床试验/NCT04684160
NCT04684160Unknown不适用

Comparison of Joint Awareness Between Fixed-bearing and Mobile-bearing Total Knee Arthroplasty Using Titanium-nitride Coated Posterior-stabilized Prostheses

The Catholic University of Korea1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年10月19日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Forgotten joint score

研究概览

简要总结

Comparison of postoperative patient's joint awareness as well as clinical and radiological outcomes between fixed- and mobile-bearing total knee arthroplasty of which the prosthesis is coated with Titanium-nitride.

详细描述

Despite numerous comparison studies between mobile- and fixed-bearing TKA as well as several comparison studies regarding clinical and radiological outcomes using titanium-nitride(TiN) prosthesis, there has been no study on postoperative joint awareness despite mobile- and fixed-bearing TKA using TiN prosthesis.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
55 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with knee joint advanced osteoarthritis
  • Age over 55 years old
  • Scheduled to undergo primary total knee arthroplasty

排除标准

  • Post-traumatic or inflammatory osteoarthritis
  • Those who undertook previous ligamentous surgery
  • Those who do not understand and give answers to a survey

结局指标

主要结局

Forgotten joint score

时间窗: Postoperative 3 years

Questionnaire of evaluating how much the patients are aware of their operate joint during daily activities. The higher, the worse. Range: 0-100

Crepitus

时间窗: Postoperative 3 years

Any grating, crackling or popping sensation around knee when moving a joint

次要结局

  • Crepitus(Postoperative 5 years)
  • Forgotten joint score(Postoperative 5 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yong In

Professor

The Catholic University of Korea

研究点 (1)

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