Status:
COMPLETED
Trial Comparing Alignment Techniques - RSA of ATTUNE Knee System
Lead Sponsor:
Canadian Radiostereometric Analysis Network
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
21-80 years
Phase:
NA
Brief Summary
The purpose of this study is to compare migration patterns between mechanical and anatomic alignment surgical techniques for the Attune S+ CR-FB knee system using model-based RSA over the first 2 post...
Detailed Description
This is a multi-centre, randomized controlled trial of patients undergoing cruciate-retaining total knee arthroplasty with the Attune S+ fixed bearing TKR system. Patients will be randomized to two st...
Eligibility Criteria
Inclusion
- Symptomatic osteoarthritis of the knee indicating primary total knee arthroplasty
- Varus knee deformity of 0 to 10 degrees
- Sufficient ligamentous function to warrant retention of the posterior cruciate ligament
- 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
- Active or prior infection
- Medical condition precluding major surgery
- Inflammatory arthropathy
- Prior patellectomy
- PCL deficiency
- Major Coronal plane deformity
- Valgus alignment
- Bone defects requiring augments, cones and/or stemmed implants
- Body Mass Index 45 or more
Key Trial Info
Start Date :
May 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2022
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT04079751
Start Date
May 5 2019
End Date
February 1 2022
Last Update
December 4 2025
Active Locations (2)
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1
Concordia Hospital
Winnipeg, Manitoba, Canada, R2K 3S8
2
London Health Sciences Centre
London, Ontario, Canada, N6A 5W9