Skip to main content
Clinical Trials/NCT02103504
NCT02103504
Completed
Not Applicable

Roentgen Stereophotogrammetric Analysis (RSA) of the ATTUNETM Posterior Stabilized Fixed Bearing Knee System

Michael Dunbar3 sites in 1 country30 target enrollmentJuly 2014
ConditionsOsteoarthritis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteoarthritis
Sponsor
Michael Dunbar
Enrollment
30
Locations
3
Primary Endpoint
Implant migration
Status
Completed
Last Updated
7 years ago

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.

Registry
clinicaltrials.gov
Start Date
July 2014
End Date
December 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor Investigator
Principal Investigator

Michael Dunbar

Orthopedic Surgeon

Nova Scotia Health Authority

Eligibility Criteria

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

Outcomes

Primary Outcomes

Implant migration

Time Frame: 2 years

Secondary Outcomes

  • Self-reported health status(2 years)
  • Functional range of motion(2 years)
  • Self-reported joint status(2 years)

Study Sites (3)

Loading locations...

Similar Trials