RecruitingNot ApplicableNCT07537153

Genicular Artery Embolization for Knee Osteoarthritis

Genicular Artery Embolization for Patients With Mild-To-Moderate Knee Osteoarthritis

Sponsor

Northwestern University

Enrollment

15 participants

Start Date

May 1, 2026

Study Type

INTERVENTIONAL

Conditions

Knee Osteoarthritis Osteoarthritis

Summary

Patients will be asked to take part in this research study because they have mild-to-moderate knee osteoarthritis (OA) and were referred clinically for a procedure called Genicular Artery Embolization (GAE). Osteoarthritis is the most common form of arthritis. It occurs when the protective cartilage that cushions the ends of the bones wears down over time. The symptoms of OA include pain or aching, stiffness, decreased range of motion, and swelling. The purpose of this study is to evaluate the safety and effectiveness of GAE for the treatment of knee pain attributed to OA. Research participants will be in this research study for about 3 years. The study includes a screening visit, GAE procedure, and six follow-up visits. At the screening visit, a review of their medical history, demographics, and medications will be collected; physical examination will be completed; knee x-ray will be done; and two questionnaires on your knee pain will be administered. The GAE procedure will involve receiving sedation or medication to help them relax, lidocaine injected under the skin in the area of the body where catheters will be inserted into one of your arteries and then using x-ray, a catheter will be directed to the arteries supplying the lining of the knee. Then tiny microspheres will be injected into the artery to decrease the blood supply to this knee joint tissue. The follow-up visits up to 12 months will include a focused physical examination of the treated knee, documentation of medications, and two questionnaires will be administered. The follow-up visits at year 2 and 3 will include documentation of medications and any new treatments for OA as well as completion of two questionnaires. Follow-up visits maybe conducted in clinic or remotely.

Eligibility

Min Age: 40 YearsMax Age: 80 Years

Inclusion Criteria7

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 Criteria12

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

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Interventions

DEVICEEmbosphere Microspheres

Genicular Artery Embolization is performed by either inserting a small catheter into the artery of the upper thigh or an artery at the wrist, and with the use of x-ray, the catheter is guided to the arteries supplying the lining of the knee. Tiny particles are then injected through the catheter into these arteries, reducing the blood supply. These small particles are considered a medical device called Embosphere Microspheres. These microspheres are approved by the Food and Drug Administration (FDA) in the United States to treat hypervascular tumors; in the prostate arteries to relieve symptoms related to benign prostate hyperplasia; and to address arteriovenous malformations. The use of Embosphere Microspheres in this study is considered experimental as it has not been approved by the FDA to reduce pain associated with knee OA.