NCT06859164 Genicular Artery Embolization for Reducing Pain in Medically Refractory Symptomatic Knee Osteoarthritis
| NCT ID | NCT06859164 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Chicago |
| Condition | Knee Osteoarthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-05-01 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 50 participants in total. It began in 2025-05-01 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Genicular Artery Embolization for Reducing Pain in Symptomatic Knee Osteoarthritis: A Pilot Randomized Sham-Controlled Study (SHAM-PAIN) is a NIH-NIAMS funded project designed to assess enrollment feasibility and detect any differences between GAE and a similar sham intervention in reducing KOA-related pain at 3 months as measured by the Knee injury and Osteoarthritis Outcome Score (KOOS) pain subscore. Additionally, this study aims to determine the magnitude of difference in pain response between GAE and sham to adequately power a larger, more definitive randomized sham-controlled trial (RCT). The influence of psychosocial and psychocognitive factors, changes in analgesic use, and conditions of knee joint cartilage and effusion will similarly be explored to determine their impacts on perceived pain response to GAE.
Eligibility 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
Contact & Investigator
Osman Ahmed, MD
PRINCIPAL INVESTIGATOR
University of Chicago Department of Radiology
Frequently Asked Questions
Who can join the NCT06859164 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 80 Years, studying Knee Osteoarthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06859164 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06859164 currently recruiting?
Yes, NCT06859164 is actively recruiting participants. Contact the research team at OAhmed@bsd.uchicago.edu for enrollment information.
Where is the NCT06859164 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT06859164 clinical trial?
NCT06859164 is sponsored by University of Chicago. The principal investigator is Osman Ahmed, MD at University of Chicago Department of Radiology. The trial plans to enroll 50 participants.