Comparison of a Metal Backed Fixed-Bearing Tibial Baseplate and an All-Polyethylene Tibia in Total Knee Arthroplasty - NCT00979147-55417 (Clinical Trial 331389)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy331389.aspx
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| City: |
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Minneapolis |
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State:
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MN |
| Zip Code: |
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55417 |
| Conditions: |
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Osteoarthritis, Knee |
| Purpose: |
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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.
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| Study summary: |
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| Criteria: |
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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 |
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| Study is available at: |
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Minneapolis VAMC
Minneapolis, MN 55417
United States
Primary Contact:
Terence J Gioe, M.D.
Email: Terence.Gioe@va.gov
Phone: 612-467-1780 |
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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: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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