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

Osteoarthritis, Knee Clinical Trial

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 Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00979147
• Other study ID #: MVA-3946B
• Status: Terminated
• Phase: N/A
• Start date: November 2007
• Est. completion date: November 2013

Study information

• Verified date: September 2020
• Source: Minneapolis Veterans Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Summary is detailed

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 400
• Est. completion date: November 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis, Knee

Intervention

Procedure:
• TKA surgery with modular polished tibial baseplate/XLK design
TKA surgery with modular polished tibial baseplate/XLK design
• 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
• P.F.C.® Sigma Knee System
P.F.C. ® Sigma Knee System with an all-poly GVF tibia

Locations

Country	Name	City	State
United States	Minneapolis VAMC	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Minneapolis Veterans Affairs Medical Center	Depuy, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical and Functional Outcomes Based on Standardized Validated TKA Outcome Instruments (KSS, KOOS, WOMAC, SF-36)	Patient recorded outcome measures as noted	2 year follow-up intervals up to 20 years
Secondary	Wear Characteristics of the Standard GVF Polyethylene vs. the Moderately Cross-linked XLK Polyethylene	Wear characteristics as above	2 year followup intervals to 20 years