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Genicular Artery Embolization for Knee Osteoarthritis Pain

This study is looking at a procedure called Genicular Artery Embolization (GAE) to reduce knee pain caused by osteoarthritis. GAE involves blocking small blood vessels (genicular arteries) in the knee that may be contributing to pain. Researchers want to see if GAE, using a substance called Lipiodol, can reduce pain more effectively than a sham (inactive) procedure. You might be able to join if you are 40-80 years old, have knee pain from osteoarthritis for over 6 months that hasn't improved with other treatments, and your pain is rated 4 or higher on a pain scale. The main goal is to see how much pain is reduced after 3 months, using a specific pain score (KOOS pain subscore). This is a pilot study to help plan a larger trial.

Study design
This is an interventional study with a planned enrollment of 50 participants. It is a pilot randomized sham-controlled study, meaning some participants will receive the active treatment and others a similar inactive procedure.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint for pain reduction is measured at 3 months after the procedure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06859164

Genicular Artery Embolization for Reducing Pain in Medically Refractory Symptomatic Knee Osteoarthritis

Recruiting
PHASE2Ages 40–80InterventionalTreatment
University of Chicago
~50 participants
Updated 2025-05-15 on ClinicalTrials.gov
What's tested:Genicular Artery EmbolizationLipiodolSimple angiogram

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Reduction in KOOS pain subscore
Measured over 3 months

Conditions

Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Knee Osteoarthritis (OA)

Explore related trials

Osteoarthritis of knee

NCT06859164

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Chicago

    Chicago, Illinoisstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Osman Ahmed, MD · PRINCIPAL_INVESTIGATOR · University of Chicago Department of Radiology

Who to contact

Osman Ahmed, MD
[email protected]
8478124513
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

Patients aged 40-80
Bilateral or unilateral knee pain attributed to osteoarthritis (treat the knee with greater pain-if equal, patient chooses)
Grade 2-4 osteoarthritis on standing weight-bearing knee radiographs per the Kellgren-Lawrence grading scale
Knee pain \> 6 months, refractory to conservative non-operative management, and scored ≥ 4 on Visual Analog Scale (VAS) (e.g., rest, activity modification, weight control, bracing, supervised physical therapy, nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen, oral opiates, intra-articular hyaluronic acid, PRP, stem cells, and/or oral/injectable corticosteroids)
Refusal of intra-articular corticosteroid injection

Exclusion

Active malignancy
Active infection of the affected knee
Corticosteroid injection of the affected knee within 3 months of enrollment
Rheumatoid arthritis or other seronegative arthropathy
Previous surgery of the affected knee (e.g., meniscus repair, meniscectomy, anterior cruciate ligament (ACL)/posterior cruciate ligament (PCL) reconstruction, chondroplasty, microfracture, loose-body removal, synovectomy, lateral release, patellar/quadriceps tendon repair, total or partial knee replacement, osteotomy, cartilage transplant), except diagnostic arthroscopy
Grade 0-1 osteoarthritis per Kellgren-Lawrence grading scale of the affected knee
Pregnancy or expected pregnancy
GFR \< 60 mL/min/1.73 m²
Anaphylactic reaction to iodinated contrast
Moderate to severe pain in other ipsilateral lower-limb joints (ankle, hip) with VAS \> 4
Body weight \> 400 lbs (unsafe for angiography)
Peripheral arterial disease of the treated extremity (Rutherford Grade 2 or greater)
Type 1 diabetes mellitus
Long-acting corticosteroid use within 6 months (3 months for short-acting)
History or other evidence of acute kidney injury (AKI)
History of reaction to contrast media, bronchial asthma, or allergic disorders
History of hypersensitivity to gadolinium-based contrast agents (GBCAs)
Chronic widespread generalized pain \>4 on VAS pain scale, including neuropathic pain
Major depressive disorder within 2 years before screening
Other severe psychiatric disorder (e.g., schizophrenia, bipolar disorder)
Suicide attempt or suicidal behavior within 30 days before screening
Diagnosis of fibromyalgia
Considering total knee replacement in the next year
Any other condition, unwillingness, or inability that, in the investigator's opinion, could jeopardize the subject's safety or protocol compliance

What this trial measures

  • Reduction in KOOS pain subscore3 months

    Percent change in KOOS pain subscale score, scaled to a range of 0-100, from baseline to 3 months post-randomization of both GAE and sham groups.