Comparison of a Metal Backed Fixed-Bearing Tibial Baseplate and an All-Polyethylene Tibia in Total Knee Arthroplasty

Comparison of a Metal Backed Fixed-Bearing Tibial Baseplate and an All-Polyethylene Tibia in Total Knee Arthroplasty

A Randomized Prospective Level 1 Comparison of a Modular Polished Fixed-Bearing Tibial Baseplate and an All-Polyethylene Tibia in Total Knee Arthroplasty

PI/study coordinator retired due to personal family health matters; study sponsor withdrew funding. Study terminated and no data collected or analyzed

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: Does a MPT/XLK design have improved wear characteristics over a nonmodular APT/GVF design? 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.

knee arthritis, total knee arthroplasty, total knee replacement, metal backed tibial component, all-polyethylene tibia, modular polished tibial baseplate

Clinical and Functional Outcomes Based on Standardized Validated TKA Outcome Instruments (KSS, KOOS, WOMAC, SF-36)

Wear Characteristics of the Standard GVF Polyethylene vs. the Moderately Cross-linked XLK Polyethylene

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