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.
Summary is detailed
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
400
TKA surgery with modular polished tibial baseplate/XLK design
TKA surgery with the nonmodular APT/GVF design
P.F.C.® Sigma Knee System with modular XLK poly
P.F.C. ® Sigma Knee System with an all-poly GVF tibia
Minneapolis VAMC
Minneapolis, Minnesota, United States
Clinical and Functional Outcomes Based on Standardized Validated TKA Outcome Instruments (KSS, KOOS, WOMAC, SF-36)
Patient recorded outcome measures as noted
Time frame: 2 year follow-up intervals up to 20 years
Wear Characteristics of the Standard GVF Polyethylene vs. the Moderately Cross-linked XLK Polyethylene
Wear characteristics as above
Time frame: 2 year followup intervals to 20 years
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