NCT06781463 · University of Chicago
Creation of a Prospective Data Collecting Registry for Genicular Artery Embolization for Arthritis
(GAE)
What this study is about
The goal of this study is to create a forward-looking 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.
View original scientific description
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.
Interventions
OTHER
Registry (N/A)
This study is a registry, thus no research intervention is being directly tested.
Primary outcome measures
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: 1 year of enrollment/patient
The investigators will describe differences in pain response with Genicular Artery Embolization (GAE) compared to a sham procedure when treating medically refractory mild to moderate Knee Osteoarthritis (KOA) at 12 months as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain subscale score. A higher score index a higher pain level while a lower score indicates lower pain levels. The score range is 0 to 100.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Chicago, Illinois
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 13, 2026 · Source of record for eligibility and locations