Reducing knee pain with Genicular Artery Embolization
Genicular Artery Embolization for Reducing Pain in Symptomatic Knee Osteoarthritis: A Pilot Randomized Sham-Controlled Study
This study is testing if a new procedure called Genicular Artery Embolization can help people with knee osteoarthritis pain who haven't found relief from other treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Sponsor | University of Chicago Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06859164 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 40-80 with knee pain due to osteoarthritis that has persisted for over six months and has not improved with conservative treatments.
Not a fit: Patients with active malignancies, infections, or those who have had recent corticosteroid injections in the affected knee may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce knee pain for patients with osteoarthritis who have not found relief through standard therapies.
How similar studies have performed: While this approach is relatively novel, similar studies exploring embolization techniques for pain relief have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Chicago, Illinois
- University of Chicago — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Osman Ahmed, MD — University of Chicago Department of Radiology
- Study coordinator: Osman Ahmed, MD
- Email: OAhmed@bsd.uchicago.edu
- Phone: 8478124513
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.