Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:45 PM
Ignite Modification Date:
2025-12-24 @ 2:45 PM
NCT ID:
NCT04822259
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04822259
Study Brief:
Protocol Section:
NCT04822259