|
Creation of a Prospective Data Collecting Registry for Genicular Artery Embolization for Arthritis
RECRUITINGSponsored by University of Chicago
Actively Recruiting
SponsorUniversity of Chicago
Started2023-10-01
Est. completion2028-10-01
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT06781463
Summary
The goal of this study is to create a prospective registry (\<100 patients) to show the effectiveness of the genicular artery embolization procedure overtime in reducing bilateral or unilateral osteoarthritic knee pain as measured by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score.
Eligibility
Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria: * Patients aged \>=18 * Bilateral or unilateral knee pain attributed to knee osteoarthritis (KOA). For bilateral KOA patients, the more severe knee will be permitted inclusion to the registry * Grade 1-3 Osteoarthritis as diagnosed on standing weight-bearing knee radiographs per the Kellen-Lawrence Grading scale * Knee pain \>6 months refractory to conservative medical management (Nonsteroidal anti-inflammatory drugs, acetaminophen, etc.) * Not eligible for surgical knee replacement or patient's personal preference to undergo Genicular Artery Embolization (GAE) for reasons such as minimally invasiveness of GAE Exclusion Criteria: * Active malignancy * Active infection of the affected knee * Platelets \<50,000/uL, INR \>2.0 (unless on anticoagulation that can be reversed or performing radial/pedal access without reversal) * Corticosteroid injection of the affected knee within 3 months of enrollment * Rheumatoid arthritis or other seronegative arthropathy * Previous surgery (excluding arthroscopy) of the affected knee * Grade 4 per Kellgren-Lawrence Grading Scale of the affected knee * Pregnancy or expected pregnancy * Glomerular Filtration Rate (GFR) \<30 * Anaphylactic reaction to iodinated contrast * Moderate to severe pain in other lower limb joints * Body weight \>400 lbs. (prohibiting safe angiography) * Peripheral arterial disease of the treated extremity (Rutherford Grade 2 or greater)
Conditions4
ArthritisKnee OsteoarthritisKnee Osteoarthritis (Knee OA)Knee Osteoarthritis (OA)
Locations1 site
University of Chicago Duchossois Center for Advanced Medicine
Chicago, Illinois, 60637
Natasha Rodwell, Bachelor of Science in Nursing773-926-8458natasha.rodwell-maxon@uchicagomedicine.org
Browse More Trials
Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.
Actively Recruiting
SponsorUniversity of Chicago
Started2023-10-01
Est. completion2028-10-01
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT06781463