CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 50 enrolled
Drug / intervention
Total Knee Replacement +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01140815
NCT01140815Phase 4Completed
CompareCT.gov

A Prospective, Single-Center, Randomized Study Comparing the Functional Performance of the Journey Deuce Bicompartmental With the Genesis II Total Knee System

Anderson Orthopaedic Research Institute·interventional·Posted Jun 10, 2010·Updated Aug 4, 2014

In Brief

A Phase 4 clinical trial evaluating Total Knee Replacement and Deuce for Knee Arthroplasty. Completed, enrolled 50 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKnee Arthroplasty
CountriesUnited States
CollaboratorsSmith & Nephew, Inc.

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 10, 2010
Enrollment StartSep 1, 2007
Primary CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 16.1 years ago

Interventions

Total Knee Replacementdevice

Smith and Nephew Total Knee Replacement

Deucedevice

Smith and Nephew Bicompartmental Knee Replacement