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Functional Performance of the Journey Deuce Bicompartmental Versus the Genesis II Total Knee System

NCT01140815 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2014-08-04

Study results available
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Summary

The objectives of this study are to assess the safety and effectiveness of the Journey Deuce Bicompartmental Knee System at 4-6 weeks, 4 months, 1 year, and 2 years when compared to total knee replacement using the Genesis II Total Knee System. The hypothesis is that the Journey Deuce Bicompartmental Knee System is as safe and effective as the Genesis II Total Knee System at the 2-year. The null hypothesis is that there is no difference between the groups.

Conditions

  • Knee Arthroplasty

Interventions

DEVICE

Total Knee Replacement

Smith and Nephew Total Knee Replacement

DEVICE

Deuce

Smith and Nephew Bicompartmental Knee Replacement

Sponsors & Collaborators

  • Smith & Nephew, Inc.

    collaborator INDUSTRY

  • Anderson Orthopaedic Research Institute

    lead OTHER

Principal Investigators

  • Gerard A. Engh, MD · AORI

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2013-05-31
Completion
2013-05-31

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 NCT01140815 on ClinicalTrials.gov