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Comparison of a Metal Backed Fixed-Bearing Tibial Baseplate and an All-Polyethylene Tibia in Total Knee Arthroplasty - NCT00979147-55417(Clinical Trial 331389)



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City:  Minneapolis
State:  
MN
Zip Code: 55417
Conditions: Osteoarthritis, Knee
Purpose: This study is designed to compare prospectively, in a randomized Level 1 evidence fashion, the clinical, functional, and radiographic results of a modular polished tibial (MPT) tray with a moderately cross-linked polyethylene (XLK) insert to an all-polyethylene tibial (APT) design with GVF polyethylene. Comparing these two designs will afford us information in the following areas: 1. Does a MPT/XLK design have improved wear characteristics over a nonmodular APT/GVF design? 2. Is there a clear clinical advantage to the MPT/XLK design in certain patient populations that justify its use over the APT/GVF design? Answering these questions will allow surgeons to use both designs appropriately in different demand populations. This study is designed to address the questions of whether an MPT/XLK design offers improvement in wear characteristics, Knee Society scores, KOOS, WOMAC, SF-36, or radiographic measures, over an APT design. The investigator's primary hypothesis is that there will be no difference in these outcome measures at a minimum two year follow-up. A secondary hypothesis based on the long-term follow-up of this group, up to twenty years, is that there will be no difference in implant survival.
Study summary:
Criteria: Inclusion Criteria: - generally accepted clinical and radiographic criteria for total knee arthroplasty Exclusion Criteria: - Significant angular or bony deformity necessitating structural bone grafting or more extensive modular designs will be excluded at the discretion of the principle investigator - Routine contraindications to TKA (active sepsis, Charcot arthropathy) - Patients whose mental function preclude them from responding to our standard questionnaires
Study is available at: Minneapolis VAMC
Minneapolis, MN 55417
United States

Primary Contact:
Terence J Gioe, M.D.
Email: Terence.Gioe@va.gov
Phone: 612-467-1780
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
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