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

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.

Study Overview

• Status: Terminated
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Procedure: TKA surgery with modular polished tibial baseplate/XLK design; Device: P.F.C.® Sigma Knee System; Device: P.F.C.® Sigma Knee System; Procedure: TKA surgery with the nonmodular APT/GVF design

Detailed Description

Summary is detailed

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55417
      • Minneapolis VAMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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; Device: P.F.C.® Sigma Knee System; P.F.C. ® Sigma Knee System with an all-poly GVF tibia
Active Comparator: All Polyethylene Tibial Baseplate; Patients who were randomized to receive the nonmodular APT/GVF TKA 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; Procedure: TKA surgery with the nonmodular APT/GVF design; TKA surgery with the nonmodular APT/GVF design; Other Names: P.F.C. ® Sigma Knee with an all-poly GVF tibia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Minneapolis Veterans Affairs Medical Center
• Collaborators: Depuy, Inc.
• Investigators: Principal Investigator: Terence J Gioe, M.D., Minneapolis VAMC

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: September 16, 2009
• First Submitted That Met QC Criteria: September 16, 2009
• First Posted (Estimate): September 17, 2009

Study Record Updates

• Last Update Posted (Actual): September 7, 2020
• Last Update Submitted That Met QC Criteria: September 3, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: total knee replacement; total knee arthroplasty; knee arthritis; metal backed tibial component; all-polyethylene tibia; modular polished tibial baseplate
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: MVA-3946B