Reducing knee pain with Genicular Artery Embolization

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of Genicular Artery Embolization (GAE) in alleviating pain for patients suffering from symptomatic knee osteoarthritis that has not responded to conventional treatments. It is a pilot randomized sham-controlled study aimed at assessing enrollment feasibility and measuring pain reduction at three months using the Knee injury and Osteoarthritis Outcome Score (KOOS) pain subscore. The study also explores the influence of psychosocial factors and changes in analgesic use on pain response, with the goal of informing a larger definitive trial in the future.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

• University of Utah
  Salt Lake City, Utah, United States Recruiting

Study contacts

• Principal investigator: Osman Ahmed, MD — University of Utah Department of Radiology
• Study coordinator: Osman Ahmed, MD
• Email: osman.ahmed@utah.edu
• Phone: 8478124513

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.