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

Not Applicable

Terminated

• Conditions: Osteoarthritis, Knee
• Interventions: 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

• Registration Number: NCT00979147
• Lead Sponsor: Minneapolis Veterans Affairs Medical Center

Brief 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

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2009-09-16
• Study First Submitted QC: 2009-09-16
• Study First Posted: 2009-09-17
• Primary Completion: 2013-05
• Study Completion: 2013-11
• Status Verified: 2020-09
• Results First Submitted: 2020-09-03
• Results First Submitted QC: 2020-09-03
• Last Update Submitted: 2020-09-03
• Results First Posted: 2020-09-07
• Last Update Posted: 2020-09-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Modular Metal Tibial Baseplate	TKA surgery with modular polished tibial baseplate/XLK design	Patients who were randomized to receive the modular polished tibial baseplate/XLK TKA
Modular Metal Tibial Baseplate	P.F.C.® Sigma Knee System	Patients who were randomized to receive the modular polished tibial baseplate/XLK TKA
All Polyethylene Tibial Baseplate	P.F.C.® Sigma Knee System	Patients who were randomized to receive the nonmodular APT/GVF TKA design.
All Polyethylene Tibial Baseplate	TKA surgery with the nonmodular APT/GVF design	Patients who were randomized to receive the nonmodular APT/GVF TKA design.

Primary Outcome Measures

Name	Time	Method
Clinical and Functional Outcomes Based on Standardized Validated TKA Outcome Instruments (KSS, KOOS, WOMAC, SF-36)	2 year follow-up intervals up to 20 years	Patient recorded outcome measures as noted

Secondary Outcome Measures

Name	Time	Method
Wear Characteristics of the Standard GVF Polyethylene vs. the Moderately Cross-linked XLK Polyethylene	2 year followup intervals to 20 years	Wear characteristics as above

Trial Locations

Locations (1)

Minneapolis VAMC; 🇺🇸 Minneapolis, Minnesota, United States