Creation of a Prospective Data Collecting Registry for Genicular Artery Embolization for Arthritis
Recruiting · NCT06781463 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of Chicago
View the official record on ClinicalTrials.gov →Interventions studied
Registry (N/A)
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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)
Where it is running
1 location listed across 1 US state.
- University of Chicago Duchossois Center for Advanced Medicine - Chicago, Illinois, United States