NCT Number: NCT02103504
DePuy Attune Total Knee Arthroplasty RSA Study
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.
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Notify MeKey information
Age range
21 year–80 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Concordia Hospital, Winnipeg, Manitoba, Canada
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Implant migration
Time frame: 2 years
Secondary outcomes
-
Functional range of motion
Time frame: 2 years
-
Self-reported health status
Time frame: 2 years
EQ-5D score
-
Self-reported joint status
Time frame: 2 years
Sponsors and collaborators
Lead sponsor
Michael Dunbar
Other
Collaborators
- Concord Hospital
- Maisonneuve-Rosemont Hospital
Registry information
Official study title
Roentgen Stereophotogrammetric Analysis (RSA) of the ATTUNETM Posterior Stabilized Fixed Bearing Knee System
Important dates
- Study start
- 2014
- Primary completion
- 2018
- Study completion
- 2018
- First posted
- Apr 4, 2014
- Registry last updated
- Feb 1, 2019
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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