Genicular Artery Embolization for Knee Osteoarthritis

NCT07537153 | Recruiting DMC FDA Device

• 1 other identifier: STU00223591
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoarthritis; Knee Osteoarthritis

Keywords

Osteoarthritis; Knee Osteoarthritis; Genicular Artery Embolization; GAE; Embosphere Microspheres; GAE Knee; GAE Embosphere Microspheres

Outcome Measures

Primary Outcomes (4)

• Patient safety endpoints

  Primary safety endpoints include: 1\. Incidence and severity of adverse events (AEs). These include: 1. Non-target embolization (e.g., distal leg) 2. All transient intra- and post-procedure events (e.g., skin changes) 3. 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 Outcomes (2)

• Preliminary Effectiveness - WOMAC

  Screening/baseline, 1, 3, 6, and 12 months

• Preliminary Effectiveness - VAS

  Screening/baseline, 1, 3, 6, and 12 months

Study Arms (1)

GAE Procedure

EXPERIMENTAL

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

Interventions

Embosphere Microspheres DEVICE

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.

GAE Procedure

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• Northwestern Memorial Hospital: collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Osteoarthritis; Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Robert Lewandowski, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Lewandowski, MD

CONTACT

312-695-9121; r-lewandowki@northwestern.edu

Kristie Kennedy, MA

CONTACT

312-695-4023; kristie.kennedy@northwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Radiology, Medicine, and Surgery; Director of Interventional Oncology

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 17, 2026
• Study Start: July 10, 2026
• Primary Completion (Estimated): April 10, 2028
• Study Completion (Estimated): April 10, 2031
• Last Updated: July 14, 2026

Record last verified: 2026-07

Locations

US (1)