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Gamma Vacuum Foil (GVF) Versus Cross-linked Polyethylene in Total Knee Arthroplasty Study

NCT00289133 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 938

Last updated 2017-04-24

Study results available
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Summary

The purpose of this study is to evaluate long-term clinical and radiographic data between geometrically identical GVF and cross-linked polyethylene-bearing inserts in total knee arthroplasty.

Conditions

  • Osteoarthritis, Knee
  • Arthritis, Rheumatoid

Interventions

DEVICE

total knee arthroplasty

Gamma Vacuum Foil polyethylene tibial insert

DEVICE

total knee arthroplasty

cross-linked polyethylene tibial insert

Sponsors & Collaborators

  • DePuy Orthopaedics

    lead INDUSTRY

Principal Investigators

  • Gracia Etienne, MD · Orthopaedic & Spine Specialists

  • Michael L. Granberry, MD · Alabama Orthopaedic Clinic

  • Richard M. Konsens, MD · Jewett Orthopaedic Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-02-01
Primary Completion
2013-05-01
Completion
2013-05-01

Countries

  • United States

Study Locations

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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 NCT00289133 on ClinicalTrials.gov