DePuy Attune Total Knee Arthroplasty RSA Study

Michael Dunbar

Status

Completed

Conditions

Osteoarthritis

Treatments

Device: DePuy Attune posterior stabilized fixed bearing total knee replacement

Study type

Interventional

Funder types

Other

Identifiers

NCT02103504

DEP ATT

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

21 to 80 years old

Volunteers

No Healthy Volunteers

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