Roentgen Stereophotogrammetric Analysis (RSA) of the ATTUNETM Posterior Stabilized Fixed Bearing Knee System
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Michael Dunbar
- Enrollment
- 30
- Locations
- 3
- Primary Endpoint
- Implant migration
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
DePuy Attune TKA
DePuy Attune posterior stabilized fixed bearing total knee replacement
Intervention: DePuy Attune posterior stabilized fixed bearing total knee replacement (Device)
Outcomes
Primary Outcomes
Implant migration
Time Frame: 2 years
Secondary Outcomes
- Self-reported joint status(2 years)
- Self-reported health status(2 years)
- Functional range of motion(2 years)
Investigators
Michael Dunbar
Orthopedic Surgeon
Nova Scotia Health Authority