CTRI/2021/10/037402
Other
Phase 4
A Prospective Multi-Centre Study in Patients undergoing Total Knee Replacement with JOURNEY II BCS and CR Total Knee System - JIICRBCSTKA
Smith Nephew Inc0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: M160- Bilateral primary osteoarthritis of hip
- Sponsor
- Smith Nephew Inc
- Status
- Other
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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Unknown
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