Roentgen Stereophotogrammetric Analysis (RSA) of the ATTUNETM Posterior Stabilized Fixed Bearing Knee System
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Osteoarthritis
- Sponsor
- Michael Dunbar
- Enrollment
- 30
- Locations
- 3
- Primary Endpoint
- Implant migration
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Michael Dunbar
Orthopedic Surgeon
Nova Scotia Health Authority
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •Active or prior infection
- •Medical condition precluding major surgery
Outcomes
Primary Outcomes
Implant migration
Time Frame: 2 years
Secondary Outcomes
- Self-reported health status(2 years)
- Functional range of motion(2 years)
- Self-reported joint status(2 years)