Status:
TERMINATED
Clinical Outcomes and Cost-effectiveness Analysis of ShapeMatch Technology
Lead Sponsor:
University of Alberta
Collaborating Sponsors:
Stryker Canada LP
Conditions:
Total Knee Arthroplasty
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
The currently held belief is that total knee replacement (TKR) requires the restoration of the overall limb alignment to coincide with the mechanical limb axis. To align the knee implants with this me...
Eligibility Criteria
Inclusion
- Patient is a male or non-pregnant female age 18 to 80 years of age at the time of study device implantation.
- Patient has primary diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD).
- Patient is a candidate for a primary total knee replacement (TKR).
- Patient is willing and able to comply with preoperative Magnetic Resonance Imaging (MRI) requirements, postoperative scheduled clinical and radiographic evaluations and rehabilitation.
Exclusion
- Patient has a Body Mass Index (BMI) ≥ 40.
- Patient has a varus or valgus deformity greater than 10 degrees or flexion contracture greater than 20o.
- Patient has an active or suspected latent infection in or about the affected joint at time of study device implantation.
- Patient has received any orthopaedic surgical intervention to the lower extremities within the past year or is expected to require any orthopaedic surgical intervention to the lower extremities, other than the TKR to be enrolled in this study, within the next year.
- Patient requires bilateral TKR, or has had a contralateral partial TKR or TKR.
- Patient has any implanted device that would be incompatible with MRI procedures.
- Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device.
- Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's Disease) leading to progressive bone deterioration.
- Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements(e.g. \> 30 days).
- Patient requires revision surgery of a previously implanted total knee replacement or knee fusion to the affected joint.
- Patient has a known sensitivity to device materials.
Key Trial Info
Start Date :
June 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 26 2015
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT01483066
Start Date
June 1 2012
End Date
June 26 2015
Last Update
July 28 2021
Active Locations (1)
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1
Alberta Health Services - Edmonton zone
Edmonton, Alberta, Canada, TG6 2B7