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Clinical Trial Summary

Background: The JOURNEY II BCS Total Knee System (JOURNEY II Bi-cruciate Stabilized Total Knee System) consists of femoral component made from oxidized zirconium (OXINIUM) The JOURNEY II CR Total Knee System (JOURNEY II Cruciate Retaining Total Knee System ) consists of femoral component made from oxidized zirconium (OXINIUM) Purpose: Post-market evidence generation for JOURNEY II BCS and JOURNEY II CR Total Knee System Objectives: 1. Evaluate the performance of JOURNEY II TKA in Asia-Pacific (APAC) patient populations 2. Establish the equivalent performance between JOURNEY II BCS and JOURNEY II CR to support adoption of JOURNEY II CR Research participants / locations: A total of at least 176 knees' information will be collected in up to 10 sites. There will be at least eighty-eight (88) knees for JOURNEY II CR TKA group and at least 88 knees for JOURNEY II BCS TKA group.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04822259
Study type Interventional
Source Smith & Nephew, Inc.
Contact
Status Withdrawn
Phase N/A
Start date August 28, 2022
Completion date December 31, 2025

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