Evaluate the Performance of JOURNEY II CR and JOURNEY II BCS in TKA Populations
Key facts
- Who runs it
- Smith & Nephew, Inc.
- Where
- China, India, and Singapore5 sites in 3 countriesChoose a country to see its sites
- Trial code
- Status
- Withdrawn
- Started
- 28 Aug 2022
- Ended
- 31 Dec 2025
- Type of study
- Interventional, 2 groups
- Treatments tested
- JOURNEY II BCS Total Knee System
- JOURNEY II CR Total Knee System
- Record updated
- 7 June 2022
- Why it stopped
- Study design is not reasonable and sponsor decided to terminate the study. No patient enrolled by now
Who can take part
- Age
- 18 years to 80 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- Subjects with degenerative osteoarthritis
- Subject is planning to have bilateral Total Knee Arthroplasty (TKA) using JOURNEY II BCS \& CR or have unilateral TKA using JOURNEY II BCS or JOURNEY II CR.*
- Subject is able and willing to provide voluntary consent to study participation
- Subject is 18-80 years old (inclusive); [* Bilateral cases can be simultaneous bilateral or staged bilateral (which an interval of 6-8 weeks apart between both knees)]
Who cannot take part
- Previous surgeries including High Tibial Osteotomy (HTO), Unicondylar Knee Arthroplasty (UKA) or Total Knee Arthroplasty (TKA) on the subject knee
- Subject is pregnant or breast feeding or those at a child-bearing age planning to become pregnant during the follow up
- Subjects with rheumatoid arthritis/inflammatory arthritis, posttraumatic arthritis
- Subject does not meet the indication or is contraindicated for JOURNEY II BCS \& JOURNEY II CR's Instructions For Use (IFU)
This trial has no sites in United States.
It has sites in 3 countries. Choose a country to see its sites.
About the trial
What the trial wants to find out
Background:
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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.
The 2 groups in the trial
- JOURNEY II BCS TKATreatment being tested
Undergoing Total Knee Replacement(resurfaced patella) with JOURNEY II BCS Total Knee System
Treatment: JOURNEY II BCS Total Knee System
- JOURNEY II CR TKATreatment being tested
Undergoing Total Knee Replacement(resurfaced patella) with JOURNEY II CR Total Knee System
Treatment: JOURNEY II CR Total Knee System
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Prospective Multi-Centre Study in Patients Undergoing Total Knee Replacement With JOURNEY II BCS and CR Total Knee System
- Record updated
- 7 June 2022