Status:
WITHDRAWN
Evaluate the Performance of JOURNEY II CR and JOURNEY II BCS in TKA Populations
Lead Sponsor:
Smith & Nephew, Inc.
Conditions:
Arthroplasty
Replacement
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Background: 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 Kn...
Eligibility Criteria
Inclusion
- 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).
- \[\* Bilateral cases can be simultaneous bilateral or staged bilateral (which an interval of 6-8 weeks apart between both knees)\]
Exclusion
- Subjects with rheumatoid arthritis/inflammatory arthritis, posttraumatic arthritis.
- 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.
- Subject does not meet the indication or is contraindicated for JOURNEY II BCS \& JOURNEY II CR's Instructions For Use (IFU).
Key Trial Info
Start Date :
August 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04822259
Start Date
August 28 2022
End Date
December 31 2025
Last Update
June 7 2022
Active Locations (5)
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1
Peking University Third Hospital
Beijing, China, 100083
2
Prince of Wales Hospital
Hong Kong, China
3
Aster RV Hospital, Bangalore
Bengaluru, Karnataka, India, 560078
4
Noble Hospital & Ruby Hall Clinic
Pune, Maharashtra, India, 411001