DePuy Attune Total Knee Arthroplasty RSA Study
Roentgen Stereophotogrammetric Analysis (RSA) of the ATTUNETM Posterior Stabilized Fixed Bearing Knee System
1 other identifier
interventional
30
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2014
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 28, 2014
CompletedFirst Posted
Study publicly available on registry
April 4, 2014
CompletedStudy Start
First participant enrolled
July 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedFebruary 1, 2019
January 1, 2019
4.4 years
March 28, 2014
January 30, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Implant migration
2 years
Secondary Outcomes (3)
Functional range of motion
2 years
Self-reported health status
2 years
Self-reported joint status
2 years
Study Arms (1)
DePuy Attune TKA
OTHERDePuy Attune posterior stabilized fixed bearing total knee replacement
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Active or prior infection
- Medical condition precluding major surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Michael Dunbarlead
- Concord Hospitalcollaborator
- Maisonneuve-Rosemont Hospitalcollaborator
Study Sites (3)
Concordia Hospital
Winnipeg, Manitoba, Canada
Capital District Health Authority
Halifax, Nova Scotia, B3H 3A7, Canada
Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Dunbar
Capital Health, Canada
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Orthopedic Surgeon
Study Record Dates
First Submitted
March 28, 2014
First Posted
April 4, 2014
Study Start
July 1, 2014
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
February 1, 2019
Record last verified: 2019-01