DePuy Attune Total Knee Arthroplasty RSA Study
- Conditions
- Osteoarthritis
- Registration Number
- NCT02103504
- Lead Sponsor
- Michael Dunbar
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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
- Active or prior infection
- Medical condition precluding major surgery
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Implant migration 2 years
- Secondary Outcome Measures
Name Time Method Self-reported health status 2 years EQ-5D score
Functional range of motion 2 years Self-reported joint status 2 years
Trial Locations
- Locations (3)
Concordia Hospital
🇨🇦Winnipeg, Manitoba, Canada
Capital District Health Authority
🇨🇦Halifax, Nova Scotia, Canada
Hopital Maisonneuve-Rosemont
🇨🇦Montreal, Quebec, Canada
Concordia Hospital🇨🇦Winnipeg, Manitoba, Canada