Comparison of a Metal Backed 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:
- 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.
|Osteoarthritis, Knee||Procedure: TKA surgery with modular polished tibial baseplate/XLK design Procedure: TKA surgery with the nonmodular APT/GVF design Device: P.F.C.® Sigma Knee System||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
|Official Title:||A Randomized Prospective Level 1 Comparison of a Modular Polished Fixed-Bearing Tibial Baseplate and an All-Polyethylene Tibia in Total Knee Arthroplasty|
- Clinical and functional outcomes based on standardized validated TKA outcome instruments (KSS, KOOS, WOMAC, SF-36) [ 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 [ Time Frame: 2 year followup intervals to 20 years ]
|Study Start Date:||November 2007|
|Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
Experimental: Modular Metal Tibial Baseplate
Patients who were randomized to receive the modular polished tibial baseplate/XLK TKA
Procedure: TKA surgery with modular polished tibial baseplate/XLK design
TKA surgery with modular polished tibial baseplate/XLK design
Other Name: P.F.C.® Sigma Knee System with modular XLK polyDevice: P.F.C.® Sigma Knee System
P.F.C.® Sigma Knee System with modular XLK poly
Active Comparator: All Polyethylene Tibial Baseplate
Patients who were randomized to receive the nonmodular APT/GVF TKA design.
Procedure: TKA surgery with the nonmodular APT/GVF design
TKA surgery with the nonmodular APT/GVF design
Other Name: P.F.C. ® Sigma Knee with an all-poly GVF tibiaDevice: P.F.C.® Sigma Knee System
P.F.C. ® Sigma Knee System with an all-poly GVF tibia
Please refer to this study by its ClinicalTrials.gov identifier: NCT00979147
|United States, Minnesota|
|Minneapolis, Minnesota, United States, 55417|
|Principal Investigator:||Terence J Gioe, M.D.||Minneapolis VAMC|