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

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