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 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 12:33 AM
NCT ID:
NCT01705067
Eligibility Criteria:
Inclusion Criteria:
* Subject received primary total knee arthroplasty with the JOURNEY™ II BCS Total Knee System due to degenerative joint disease
* Subject is willing to sign and date an IRB approved consent form
* Subject is of legal age to consent
* Subject plans to be available through ten (10) years postoperative follow-up
* Subject agrees to follow the study protocol
Exclusion Criteria:
* Subject received the JOURNEY™ II BCS Total Knee System on the affected knee as a revision for a previously failed total or unicondylar knee arthroplasty
* Subject received TKA on the contralateral knee as a revision for a previously failed total or unicondylar knee arthroplasty
* Subject possesses a contralateral or ipsilateral revision hip arthroplasty
* Subject has ipsilateral hip arthritis resulting in flexion contracture
* At the time of enrollment, subject has one or more of the following arthroplasties that are not fully healed and well-functioning, as determined by the investigator:
* Ipsilateral or contralateral primary total hip arthroplasty or hip resurfacing arthroplasty
* Contralateral primary total knee or unicondylar knee arthroplasty
* At the time of surgery, subject had an active infection or sepsis (treated or untreated)
* At the time of surgery, subject had presence of malignant tumor, metastatic, or neoplastic disease
* At the time of surgery, subject had conditions 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)
* At the time of surgery, subject had contralateral lower extremity condition causing abnormal ambulation
* Subject is pregnant or plans to become pregnant during the study
* Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
* At the time of surgery, subject had a BMI\>40
* At the time of enrollment, subject has a BMI\>40
* Subject is enrolled in another investigational drug, biologic, or device study
* Subject is facing current or impending incarceration
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT01705067
Study Brief:
Protocol Section:
NCT01705067