DePuy Attune Total Knee Arthroplasty RSA Study

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02103504
• Other study ID #: DEP ATT
• Status: Completed
• Phase: N/A
• Start date: July 2014
• Est. completion date: December 2018

Study information

• Verified date: January 2019
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Device:
• DePuy Attune posterior stabilized fixed bearing total knee replacement

Locations

Country	Name	City	State
Canada	Capital District Health Authority	Halifax	Nova Scotia
Canada	Hopital Maisonneuve-Rosemont	Montreal	Quebec
Canada	Concordia Hospital	Winnipeg	Manitoba

Sponsors (3)

Lead Sponsor	Collaborator
Michael Dunbar	Concord Hospital, Maisonneuve-Rosemont Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant migration		2 years
Secondary	Functional range of motion		2 years
Secondary	Self-reported health status	EQ-5D score	2 years
Secondary	Self-reported joint status		2 years