Status:
ACTIVE_NOT_RECRUITING
Porous Baseplate in Total Knee Replacement
Lead Sponsor:
Canadian Radiostereometric Analysis Network
Conditions:
Knee Osteoarthritis
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 Advance Porous fixed bearing tibial baseplate and compatible femoral, patellar, an...
Detailed Description
All patients will undergo post-operative model-based RSA to identify migration of the tibial baseplate with respect to the bone as well as migration of the patellar and femoral components with respect...
Eligibility Criteria
Inclusion
- Symptomatic osteoarthritis of the knee indicating primary unilateral total knee arthroplasty
- Sufficient ligamentous function to warrant retention of the posterior cruciate ligament
- Aged 21 years or older
- 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
- Known medical condition limiting patient life expectancy to \< 2 years
- Expected to receive contralateral TKA within 1 year
- Inflammatory arthropathy
- Prior patellectomy
- PCL deficiency
- Major (\>25 degree) coronal plane deformity
- Bilateral coronal plane deformity requiring simultaneous bilateral TKA
- Bone defects requiring augments, cones and/or stemmed implants
- Body Mass Index greater than 40
Key Trial Info
Start Date :
April 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2026
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT05226689
Start Date
April 11 2022
End Date
July 1 2026
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