Evaluate the Performance of JOURNEY II CR in TKA Populations
Key facts
- Who runs it
- Smith & Nephew, Inc.
- Where
- China, India, Japan, Singapore, and Thailand8 sites in 5 countriesChoose a country to see its sites
- Trial code
- Status
- Terminated
- People taking part
- 62 people enrolled
- Started
- 3 Mar 2022
- Ended
- 15 Mar 2024
- Type of study
- Observational, 2 groups
- Treatments tested
- Resurfaced Patella
- Un-resurfaced Patella
- Record updated
- 20 August 2025
- Why it stopped
- It was terminated by sponsor for updated evidence needs
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
Show all 8 criteriaShow less
Who can take part
- Subjects with degenerative osteoarthritis
- Subject is planning to have TKA using JOURNEY II CR
- Subject is able and willing to provide voluntary consent to study participation
- Subject is 18-80 years old (inclusive) * (* For Japan, the minimum inclusion age is 20 years old.)
Who cannot take part
- Previous surgeries including HTO, UKA or 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 CR's IFU
This trial has no sites in United States.
It has sites in 5 countries. Choose a country to see its sites.
About the trial
What the trial wants to find out
Background:
Read full original descriptionShow less
The JOURNEY II CR Total Knee System consists of femoral component made from oxidized zirconium (OXINIUM)
Purpose:
Post-market evidence generation for JOURNEY II CR Total Knee System
Objectives:
Evaluate the performance of JOURNEY II CR TKA in APAC populations Evaluate the impact of patella resurfacing on the outcomes of JOURNEY II CR TKA
Research participants / locations:
A total of up to 480 knees' information will be collected in up to 15 sites in India, China mainland, Hong Kong, Singapore, Thailand and Japan There will be up to 240 knees for resurfaced patella group and up to 240 knees for un-resurfaced patella group.
The 2 groups in the trial
- Resurfaced/non patella
Undergoing Total Knee Replacement with JOURNEY II CR Total Knee System
Treatment: Resurfaced Patella
- un-resurfaced patella
Undergoing Total Knee Replacement with 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 CR Total Knee System
- Record updated
- 20 August 2025