Status:
ACTIVE_NOT_RECRUITING
Radiographic Migration Analysis of the ATTUNE Cementless CR Fixed-Bearing Total Knee Replacement
Lead Sponsor:
Canadian Radiostereometric Analysis Network
Conditions:
Osteo Arthritis Knee
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
This is a multi-centre, single cohort trial of patients undergoing cruciate-retaining total knee arthroplasty with the Attune Cementless, Fixed Bearing, Cruciate Retaining TKA System.
Detailed Description
All patients will undergo post-operative radiostereometric analysis (RSA) and computed tomography (CT) to quantify and characterize the in vivo migration pattern of the Attune AFFIXIUM Cementless Tibi...
Eligibility Criteria
Inclusion
- Symptomatic osteoarthritis of the knee indicating primary total knee arthroplasty
- Patients aged 21 years or older
- Sufficient ligamentous function to warrant retention of the posterior cruciate ligament
- Patients willing and able to comply with follow-up requirements and self-evaluations
- Ability to give informed consent
Exclusion
- Active or prior infection of ipsilateral extremity
- Medical condition precluding major surgery
- Inflammatory arthropathy
- Posterior cruciate ligament (PCL) deficiency
- Major coronal plane deformity
- Conditions that are cautioned against or contraindicated, as listed in the product monograph and/or instruction for use
- Bone defects requiring augments, cones and/or stemmed implants
Key Trial Info
Start Date :
October 21 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06189872
Start Date
October 21 2024
End Date
June 1 2027
Last Update
December 4 2025
Active Locations (3)
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1
Orthopaedic Innovation Centre
Winnipeg, Manitoba, Canada, R2K 2M9
2
Nova Scotia Health - Orthopedic
Halifax, Nova Scotia, Canada, B3H 2E1
3
London Health Sciences Centre
London, Ontario, Canada, N6A 5W9