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

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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
We found this trial at
1
site
Minneapolis, Minnesota 55417
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mi
from
Minneapolis, MN
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