Registry for Genicular Artery Embolization in Knee Osteoarthritis
Creation of a Prospective Data Collecting Registry for Genicular Artery Embolization for Arthritis (GAE)
This study is trying to see if a new procedure called genicular artery embolization can help reduce knee pain in adults with osteoarthritis who aren't able to have surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Chicago Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06781463 on ClinicalTrials.gov |
What this trial studies
This study aims to create a prospective registry to evaluate the effectiveness of genicular artery embolization (GAE) in reducing knee pain associated with osteoarthritis. The registry will include patients aged 18 and older who have experienced knee pain for over six months and are not candidates for surgical knee replacement. The effectiveness of GAE will be measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score, and MRI will be utilized to assess knee remodeling post-procedure. The study will involve fewer than 100 patients and seeks to provide a comprehensive understanding of GAE's long-term benefits.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with bilateral or unilateral knee pain due to osteoarthritis that has not improved with conservative medical management.
Not a fit: Patients with active malignancies, infections, or those who have had recent corticosteroid injections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a minimally invasive alternative for patients suffering from knee osteoarthritis who do not respond to conventional treatments.
How similar studies have performed: Previous small cohort studies have shown significant pain reduction with genicular artery embolization, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Chicago, Illinois
- University of Chicago Duchossois Center for Advanced Medicine — Chicago, Illinois, United States (Recruiting)
Study contacts
- Study coordinator: Tiana Jackson
- Email: Tiana.Jackson@bsd.uchicago.edu
- Phone: 773.795.7030
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.