Osteoarthritis
Conditions
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.
Interventions
DEVICEDePuy Attune posterior stabilized fixed bearing total knee replacement
Sponsors
Concord Hospital
Maisonneuve-Rosemont Hospital
Michael Dunbar
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Implant migration | 2 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional range of motion | 2 years | — |
| Self-reported health status | 2 years | EQ-5D score |
| Self-reported joint status | 2 years | — |
Countries
Canada
Outcome results
None listed