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NCT Number: NCT07537153

Genicular Artery Embolization for 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.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Knee Osteoarthritis Musculoskeletal Diseases Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

Location status: Recruiting

Location contact

Robert Lewandowski, MD

CONTACT

[email protected]

312-695-9121

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Patient safety endpoints

    Time frame: Screening/baseline, 1, 3, and 6 months

    Primary safety endpoints include:

    • 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

  2. Objective clinical endpoints - Cone beam computed tomography

    Time frame: Immediately pre-and post-embolization

    Change in enhancement on cone beam computed tomography (CT)

  3. Objective clinical endpoints - VAS

    Time frame: Screening/baseline, 1, 3, 6, 12, 24 and 36 months

    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

  4. Objective clinical endpoints - WOMAC

    Time frame: Screening/baseline, 1, 3, 6, 12, 24 and 36 months

    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).

Secondary outcomes

  1. Preliminary Effectiveness - WOMAC

    Time frame: Screening/baseline, 1, 3, 6, and 12 months

    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).

  2. Preliminary Effectiveness - VAS

    Time frame: Screening/baseline, 1, 3, 6, and 12 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kristie Kennedy, MA

CONTACT

[email protected]

312-695-4023

Robert Lewandowski, MD

CONTACT

[email protected]

312-695-9121

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • Northwestern Memorial Hospital

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2031
First posted
Apr 17, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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