Comparison of a Metal Backed Fixed-Bearing Tibial Baseplate and an All-Polyethylene Tibia in Total Knee Arthroplasty
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00979147|
Recruitment Status : Terminated (PI/study coordinator retired due to personal family health matters; study sponsor withdrew funding. Study terminated and no data collected or analyzed)
First Posted : September 17, 2009
Results First Posted : September 7, 2020
Last Update Posted : September 7, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|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||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||November 2007|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||November 2013|
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 poly
Device: 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 tibia
Device: P.F.C.® Sigma Knee System
P.F.C. ® Sigma Knee System with an all-poly GVF tibia
- 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 ]Patient recorded outcome measures as noted
- Wear Characteristics of the Standard GVF Polyethylene vs. the Moderately Cross-linked XLK Polyethylene [ Time Frame: 2 year followup intervals to 20 years ]Wear characteristics as above
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00979147
|United States, Minnesota|
|Minneapolis, Minnesota, United States, 55417|
|Principal Investigator:||Terence J Gioe, M.D.||Minneapolis VAMC|