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:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-25 @ 2:22 AM
NCT ID:
NCT03317834
Eligibility Criteria:
Inclusion Criteria:
1. Subject requires primary total knee arthroplasty with the Journey II BCS or Cruciate-Retraining (CR) Systems due to degenerative joint disease (primary diagnosis of osteoarthritis, post-traumatic arthritis, avascular necrosis, rheumatoid arthritis.
2. Subject was considered skeletally mature at the time of cone implantation (at least 18 years or older.)
3. Subject agrees to consent to and to follow the study visit schedule (as defined in the study protocol and informed consent form) by signing the IRB/EC approved informed consent form.
4. Subject plans to be available through two (2) years postoperative follow-up.
Exclusion Criteria:
1. Subject has BMI ≥ 40.
2. Subject has condition(s) that may interfere with the TKA survival or outcome (i.e., Paget's or Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease, or an active, local infection).
3. Subject is deemed by investigator to require a constrained or deep dish tibial insert.
4. Subject has inadequate bone stock to support the device (severe osteopenia, history of severe osteoporosis or severe osteopenia).
5. Subject has mental or neurologic condition(s) that may pre-empt the ability or willingness to restrict activities.
6. Subject is 80 years of age or older.
7. Subject is a prisoner or impending incarceration.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
80 Years
Study:
NCT03317834
Study Brief:
Protocol Section:
NCT03317834