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 Embozeneâ„¢ Color-Advanced Microspheres. Patients will be followed up for a total of 12 months.
Who can participate
Age range30 Years – 80 Years
SexALL
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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
✕. Active systemic or local knee infection;
✕. Active malignancy;
✕. Life expectancy less than 12 months;
✕. 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;
What they're measuring
1
Percentage Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Pain Score