Status:
WITHDRAWN
Comparing X-3 To N2vac Polyethylene With the Triathlon Total Knee System
Lead Sponsor:
Dalhousie University
Collaborating Sponsors:
Stryker Canada LP
Conditions:
Osteoarthritis
OA
Eligibility:
All Genders
21-75 years
Phase:
PHASE4
Brief Summary
Methodology: This study will be a randomized, multi-center evaluation comparing N2vac polyethylene inserts and patellas with X3 inserts and patellas when used in the Triathlon PS total knee system. S...
Eligibility Criteria
Inclusion
- The subject requires a primary cemented total knee replacement.
- The subject has a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN).
- The subject has intact collateral ligaments.
- The subject has signed the ethic committee approved, study specific Informed Patient Consent Form.
- The subject is willing and able to comply with post-operative scheduled clinical and radiographic evaluations and rehabilitation.
Exclusion
- The subject has inflammatory arthritis.
- The subject is morbidly obese, BMI \> 40.
- The subject has a history of total or unicompartmental reconstruction of the affected joint.
- The subject has had a high tibial osteotomy or femoral osteotomy.
- The subject has a neuromuscular or neurosensory deficiency, that would limit the ability to assess the performance of the device.
- The subject has a systemic or metabolic disorder leading to progressive bone deterioration.
- The subject is immunologically suppressed, or receiving chronic steroids (\>30 days duration).
- The subject's bone stock is compromised by disease or infection and cannot provide adequate support and/or fixation to the prosthesis.
- The subject has had a knee fusion at the affected joint.
- The subject has an active or suspected latent infection in or about the knee joint.
- The subject is a prisoner.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00665964
Start Date
May 1 2008
End Date
May 1 2020
Last Update
January 31 2019
Active Locations (1)
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1
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 3A7