JOURNEY II XR Safety and Effectiveness PMCF (NCT03136887) | Clinical Trial Compass
Active — 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 range
22 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. require TKA due to rheumatoid arthritis, post-traumatic arthritis, osteoarthritis, or degenerative arthritis, failed osteotomies, or failed unicompartmental replacement
. have all cruciate and collateral ligaments intact in the index joint
. adult patients that in the judgement of the Investigator are skeletally mature
. be willing and able to participate in required follow-up visits at the investigational site and to complete study procedures and questionnaires
. consent to participate in the study by signing the IRB/EC approved informed consent form
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is tracking how long the JOURNEY II XR knee replacement implant lasts over time — what does the current implant survival data look like so far, and how does that compare to other knee replacement implants my doctor has experience with?
2Since this trial is listed as 'active, not recruiting,' it means they're no longer enrolling new participants — so could my doctor walk me through whether the JOURNEY II XR implant is still being used in standard care, and whether it would even be an option for my specific condition like osteoarthritis or post-traumatic knee damage?
3This is a post-market follow-up study rather than a traditional phase trial, which means the implant is already approved and in use — but what real-world safety signals or complications, if any, have been reported so far that my doctor thinks I should know about before choosing this implant?
4My knee condition could fall into several of the categories this study covers, like osteoarthritis or a failed prior procedure — how would my doctor determine which type of knee replacement design is the best fit for my particular situation, and is the JOURNEY II XR specifically suited to my case?
5Since the study is still collecting long-term data on how well this implant holds up, does that mean there are still unknowns about its durability compared to other options, and should I consider waiting for more complete results before making a decision?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. have any of the following conditions in the index joint:
. have any of the following conditions in the contralateral joint:
. have any of the following conditions of the hip:
. have a diagnosis of an immunosuppressive disorder
. have an active infection, treated or untreated, systemic or at the site of the planned surgery
. 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