Overview

This trial is active, not recruiting.

Condition osteoarthritis
Treatment depuy attune posterior stabilized fixed bearing total knee replacement
Sponsor Michael Dunbar
Collaborator Concord Hospital
Start date July 2014
End date December 2016
Trial size 30 participants
Trial identifier NCT02103504, DEP ATT

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
DePuy Attune posterior stabilized fixed bearing total knee replacement
depuy attune posterior stabilized fixed bearing total knee replacement

Primary Outcomes

Measure
Implant migration
time frame: 2 years

Secondary Outcomes

Measure
Functional range of motion
time frame: 2 years
Self-reported health status
time frame: 2 years
Self-reported joint status
time frame: 2 years

Eligibility Criteria

Male or female participants from 21 years up to 80 years old.

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

Additional Information

Official title Roentgen Stereophotogrammetric Analysis (RSA) of the ATTUNETM Posterior Stabilized Fixed Bearing Knee System
Principal investigator Michael Dunbar
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Nova Scotia Health Authority.