Evaluate the performance of JOURNEY II CR and JOURNEY II BCS in TKA populations
Phase 4
- Conditions
- Health Condition 1: M160- Bilateral primary osteoarthritis of hip
- Registration Number
- CTRI/2021/10/037402
- 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 bilateral TKA using JOURNEY II BCS&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 BCS &CR’s IFU.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Radiographic AssessmentTimepoint: 6 months, 1 year, 2 years, 3 years
- Secondary Outcome Measures
Name Time Method Forgotten Joint Score (FJS)Timepoint: 6 months, 1 year , 2 years , 3 years;Knee Society Score (KSS)Timepoint: 6 months, 1 year , 2 years , 3 years;Patient SatisfactionTimepoint: 6 months, 1 year, 2 years, 3 years