JOURNEY II XR Safety and Effectiveness PMCF (NCT03136887) | Clinical Trial Compass
Active ā Not RecruitingNot Applicable
JOURNEY II XR Safety and Effectiveness PMCF
United States176 participantsStarted 2017-07-28
Plain-language summary
This study was designed to demonstrate the safety and performance of the JOURNEY II XR total knee system by evaluating implant survival rates at 10 years using Kaplan-Meier analysis. All participants will be implanted with the JOURNEY II XR total knee system.
Who can participate
Age range22 Years ā 75 Years
SexALL
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Inclusion criteria
ā. require TKA due to rheumatoid arthritis, post-traumatic arthritis, osteoarthritis, or degenerative arthritis, failed osteotomies, or failed unicompartmental replacement
ā. have all cruciate and collateral ligaments intact in the index joint
ā. adult patients that in the judgement of the Investigator are skeletally mature
ā. be willing and able to participate in required follow-up visits at the investigational site and to complete study procedures and questionnaires
ā. consent to participate in the study by signing the IRB/EC approved informed consent form
Exclusion criteria
ā. have any of the following conditions in the index joint:
ā. have any of the following conditions in the contralateral joint:
ā. have any of the following conditions of the hip:
ā. have a diagnosis of an immunosuppressive disorder
ā. have an active infection, treated or untreated, systemic or at the site of the planned surgery
ā. have conditions that may interfere with the TKA survival or outcome, including but not limited to: Paget's disease, Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, renal insufficiency or neuromuscular disease