NCT00979147

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: Minneapolis Veterans Affairs Medical Center · Federal
• Sex: All
• Age: 60 Years – 85 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

Summary is detailed

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
PROCEDURE	TKA surgery with modular polished tibial baseplate/XLK design	TKA surgery with modular polished tibial baseplate/XLK design
PROCEDURE	TKA surgery with the nonmodular APT/GVF design	TKA surgery with the nonmodular APT/GVF design
DEVICE	P.F.C.® Sigma Knee System	P.F.C.® Sigma Knee System with modular XLK poly
DEVICE	P.F.C.® Sigma Knee System	P.F.C. ® Sigma Knee System with an all-poly GVF tibia

Timeline

• Start date: 2007-11-01
• Primary completion: 2013-05-01
• Completion: 2013-11-01
• First posted: 2009-09-17
• Last updated: 2020-09-07
• Results posted: 2020-09-07

Locations

1 site across 1 country: United States