Comparison of a Metal Backed Fixed-Bearing Tibial Baseplate and an All-Polyethylene Tibia in Total Knee Arthroplasty
Status: | Recruiting |
---|---|
Conditions: | Arthritis, Osteoarthritis (OA) |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 60 - 85 |
Updated: | 5/27/2013 |
Start Date: | November 2007 |
Contact: | Terence J Gioe, M.D. |
Email: | Terence.Gioe@va.gov |
Phone: | 612-467-1780 |
A Randomized Prospective Level 1 Comparison of a Modular Polished Fixed-Bearing Tibial Baseplate and an All-Polyethylene Tibia in Total Knee Arthroplasty
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.
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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