MedTrace Logo

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

NCT00979147 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2020-09-07

Study results available
· View outcomes & findings →

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.

Conditions

  • Osteoarthritis, Knee

Interventions

PROCEDURE

TKA surgery with modular polished tibial baseplate/XLK design

TKA surgery with modular polished tibial baseplate/XLK design

PROCEDURE

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

DEVICE

P.F.C.® Sigma Knee System

P.F.C. ® Sigma Knee System with an all-poly GVF tibia

Sponsors & Collaborators

  • Depuy, Inc.

    collaborator INDUSTRY

  • Minneapolis Veterans Affairs Medical Center

    lead FED

Principal Investigators

  • Terence J Gioe, M.D. · Minneapolis VAMC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2013-05-31
Completion
2013-11-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00979147 on ClinicalTrials.gov