Genicular Artery Embolization for Knee Osteoarthritis

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

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.

Study Overview

• Status: Recruiting
• Conditions: Osteoarthritis; Knee Osteoarthritis
• Intervention / Treatment: Device: Embosphere Microspheres

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kristie Kennedy, MA; Phone Number: 312-695-4023; Email: kristie.kennedy@northwestern.edu
• Study Contact Backup: Name: Robert Lewandowski, MD; Phone Number: 312-695-9121; Email: r-lewandowki@northwestern.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern University
      • Contact: Robert Lewandowski, MD; Phone Number: 312-695-9121; Email: r-lewandowski@northwestern.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: GAE Procedure; All participants will undergo a procedure called Genicular Artery Embolization (GAE) that will be done to try to reduce the pain in their knees.

Device: Embosphere 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient safety endpoints	Primary safety endpoints include: 1. Incidence and severity of adverse events (AEs). These include: Non-target embolization (e.g., distal leg); All transient intra- and post-procedure events (e.g., skin changes); Death	Screening/baseline, 1, 3, and 6 months
Objective clinical endpoints - Cone beam computed tomography	Change in enhancement on cone beam computed tomography (CT)	Immediately pre-and post-embolization
Objective clinical endpoints - VAS	Change in Visual Analogue Scale (VAS), a measurement instrument where 0 represents the minimum value (e.g., no pain) and 100 (or 10) represents the maximum value (e.g., worst imaginable pain). Consequently, higher scores indicate a worse outcome (more pain/severity), while lower scores indicate a better outcome	Screening/baseline, 1, 3, 6, 12, 24 and 36 months
Objective clinical endpoints - WOMAC	Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), a measurement instrument designed to evaluate pain, stiffness, and physical function in patients with hip or knee osteoarthritis. Higher scores on the WOMAC indicate a worse outcome (greater pain, stiffness, and functional limitations).	Screening/baseline, 1, 3, 6, 12, 24 and 36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preliminary Effectiveness - WOMAC	Secondary endpoint will be evaluated based on existing validated pain scoring systems. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), a measurement instrument designed to evaluate pain, stiffness, and physical function in patients with hip or knee osteoarthritis will be utilized. Higher scores on the WOMAC indicate a worse outcome (greater pain, stiffness, and functional limitations).	Screening/baseline, 1, 3, 6, and 12 months
Preliminary Effectiveness - VAS	Secondary endpoint will be evaluated based on existing validated pain scoring systems. The Visual Analogue Scale (VAS), a measurement instrument where 0 represents the minimum value (e.g., no pain) and 100 (or 10) represents the maximum value (e.g., worst imaginable pain) will be utilized. Consequently, higher scores indicate a worse outcome (more pain/severity), while lower scores indicate a better outcome.	Screening/baseline, 1, 3, 6, and 12 months

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: Northwestern Memorial Hospital
• Investigators: Principal Investigator: Robert Lewandowski, MD, Northwestern University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): April 10, 2028
• Study Completion (Estimated): April 10, 2031

Study Registration Dates

• First Submitted: April 8, 2026
• First Submitted That Met QC Criteria: April 15, 2026
• First Posted (Actual): April 17, 2026

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Osteoarthritis; Knee Osteoarthritis; Genicular Artery Embolization; GAE; Embosphere Microspheres; GAE Knee; GAE Embosphere Microspheres
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: STU00223591

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes