Evaluate the performance of JOURNEY II CR in TKA populations
Phase 4
- Conditions
- Health Condition 1: M179- Osteoarthritis of knee, unspecified
- Registration Number
- CTRI/2021/10/037334
- Lead Sponsor
- Smith Nephew Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
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)
Exclusion Criteria
•Subjects with rheumatoid arthritis/inflammatory arthritis, posttraumatic arthritis.
•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.
•Subject does not meet the indication or is contraindicated for JOURNEY II CR’s IFU
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method