Geniculate Artery Embolization for Treatment of Osteoarthritis (NCT04379700) | Clinical Trial Compass
CompletedNot Applicable
Geniculate Artery Embolization for Treatment of Osteoarthritis
United States38 participantsStarted 2020-12-01
Plain-language summary
Single-arm, single-center, no sham or placebo, prospective pilot trial designed to evaluate the feasibility and safety of transcatheter arterial embolization in patients with mild to moderate radiographic knee OA. Eligible participants will receive geniculate artery embolization using Embozene™ Color-Advanced Microspheres. Patients will be followed up for a total of 12 months.
Who can participate
Age range
30 Years – 80 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
. 30-80 years of age of any gender;
. Kellgren-Lawrence Grade 2, 3, or 4 (in select subjects who have no bony deformity) knee OA on most recent knee radiograph obtained within 6 months of screening visit;
. Knee pain resistant to conservative treatment for at least 3 months (anti- inflammatory drugs, acetaminophen, physical therapy, muscle strengthening, or intra- articular injection of hyaluronic acid and/or steroids);
. Moderate to severe knee pain: pain VAS ≥ 40 mm with 0 representing 'no pain' and 100 'the worst pain imaginable. If both knees meet inclusion criteria, the one with a higher VAS score will be chosen for the study (i.e., target knee).
. Willing, able, and mentally competent to provide informed consent and complete study questionnaires in English. The Study questionnaire is validated in English.
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.
What they're measuring
1
Percentage Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Pain Score
. Prior ipsilateral knee surgery (within 3 years of baseline visit), arthroscopic surgery (within 6 months of baseline), total or partial knee replacement regardless of timing;
. Ipsilateral knee intra-articular injection in the last 3 months;
. Rheumatoid arthritis, spondyloarthropathies, crystal disease, gout, pseudogout, or lupus;
. Pregnant during the study period;
. Renal dysfunction as defined by serum creatinine \>1.6 dl/mg or eGFR \<60 on blood tests obtained within 30 days of procedure;