Genicular Artery Embolization for Knee Osteoarthritis
Official title: Genicular Artery Embolization for Patients With Mild-To-Moderate Knee Osteoarthritis
Run by Northwestern University · NCT07537153 · Data updated 2026-11-12
This study tests whether Genicular Artery Embolization can relieve knee pain in adults with mild-to-moderate knee osteoarthritis who have tried standard treatments.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 40 Years to 80 Years |
| Sex | All |
| Enrollment | 15 (estimated) |
| Sponsor | Northwestern University Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Status | Recruiting |
| Started | July 10, 2026 |
| Main results expected | April 10, 2028 |
| Study ends | April 10, 2031 |
| Registry record updated | July 14, 2026 |
| Trial ID | NCT07537153 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 40-80 with mild-to-moderate knee OA (KL grade 2-3) and pain ≥5/10 who have failed at least 3 months of conservative therapy and can commit to follow-up.
✕Probably not a fit
Patients with severe OA (KL 4), inflammatory arthritis, prior knee replacement in the study knee, or those at high risk from angiography may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study evaluates the safety and effectiveness of Genicular Artery Embolization (GAE) using Embosphere Microspheres for knee osteoarthritis. Participants aged 40-80 with Kellgren-Lawrence grade 2-3 OA and meaningful knee pain will undergo GAE and be followed for approximately three years, including a screening visit, the procedure, and six follow-up visits. The study collects medical history, imaging, and pain questionnaires to assess outcomes while monitoring for adverse events. Eligibility requires radiographic OA severity, adequate pain, prior conservative therapy, and ability to comply with follow-up. Exclusion criteria include inflammatory arthritis, prior knee arthroplasty in the affected knee, significant kidney dysfunction, contrast allergy, infection, pregnancy, and other risks that could affect participation.
Why it matters
Potential benefit: If successful, GAE could reduce knee pain and improve function for people with knee OA who have not responded to conservative care.
How similar studies have gone: Previous studies of GAE in knee OA have shown potential pain reduction, but large randomized data are still emerging, making this an area with growing but not yet definitive evidence.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 40-80 years * Mild-to-moderate knee OA as determined by radiographs demonstrating Kellgren- Lawrence grade 2-3 * Self-reported pain of at least 5/10 VAS questionnaire * Failure of conservative therapy, such as pain medications, for at least 3 months * Patient must understand and sign the informed consent * Patient can comply with the proposed follow-up schedule * Patient can follow the post-operative management Exclusion Criteria: * History of rheumatoid arthritis * Renal insufficiency precluding angiography (GFR \< 50 mL/min) * Irreversible coagulopathy * Previous knee arthroplasty on the intended knee * Existing knee joint infection * Kellgren-Lawrence grade 1 or 4 * Severe atherosclerosis as manifest by claudication and/or diminished peripheral pulses * Life expectancy \< 6 months * Infectious arthritis * Allergy to iodinated contrast resulting in anaphylaxis * Pregnant or interested in becoming pregnant three months from the date of the GAE procedure * Involved in litigation or worker's compensation claims
Where it's running
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Northwestern University
Chicago, Illinois, United States Recruiting
Study contacts
- Principal investigator: Robert Lewandowski, MD — Northwestern University
- Study coordinator: Robert Lewandowski, MD
- Email: r-lewandowki@northwestern.edu
- Phone: 312-695-9121
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.