Creation of a Prospective Data Collecting Registry for Genicular Artery Embolization for Arthritis
Creation of a Prospective Data Collecting Registry for Genicular Artery Embolization for Arthritis (GAE)
University of Chicago
100 participants
Oct 1, 2023
OBSERVATIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria13
- 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)
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Interventions
This study is a registry, thus no research intervention is being directly tested.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06781463