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临床试验/NCT02103504
NCT02103504已完成不适用

Roentgen Stereophotogrammetric Analysis (RSA) of the ATTUNETM Posterior Stabilized Fixed Bearing Knee System

Michael Dunbar4 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2014年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
4
主要终点
Implant migration

研究概览

简要总结

The DePuy Attune knee system incorporates several key features aimed at improving kinematics of the knee joint, range of motion, and smoothness of use compared to existing total knee replacement technologies. As this is a newly approved medical device, clinical testing in patients using high precision diagnostics is important to evaluate the stability of implant fixation and in vivo function. We propose a multi-centre consecutive series study examining the stability of the Attune posterior-stabilized knee design in 30 patients undergoing total knee arthroplasty for a follow-up period of 2 years. Radiostereometric analysis (RSA) will be utilized to identify the micromotion of the tibial tray with respect to the surrounding bone. Health status and functional outcome measures will be recorded to quantify functional status of subjects before surgery and at follow-up intervals.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
21 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Symptomatic osteoarthritis of the knee indicating primary total knee arthroplasty
  • Between the ages of 21 and 80 inclusive
  • Patients willing and able to comply with follow-up requirements and self-evaluations
  • Ability to give informed consent

排除标准

  • Active or prior infection
  • Medical condition precluding major surgery

结局指标

主要结局

Implant migration

时间窗: 2 years

次要结局

  • Self-reported health status(2 years)
  • Functional range of motion(2 years)
  • Self-reported joint status(2 years)

研究者

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

Michael Dunbar

Orthopedic Surgeon

Nova Scotia Health Authority

研究点 (4)

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DePuy Attune Total Knee Arthroplasty RSA Study | 临床试验