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NCT07494838
IMAGES: Identifying Metabolic Imaging Association With Genicular Artery Embolization Success
Conditions: Knee Osteoarthritis, Knee Discomfort, Knee Pain Chronic, Knee Swelling Pain
Sex: All
Ages: 40 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 25
Sponsor: Lucas R. Cusumano, MD
Location: University of California, Los Angeles Los Angeles California
Summary
Several clinical trials on genicular artery embolization (GAE) show significant clinical benefit for the majority of patients. However, a proportion of patients do not benefit from GAE, and responses vary across individual patients. Changes in metabolic activity on non-invasive imaging may correlate with improvement in symptoms of knee osteoarthritis. This study will assess changes in metabolic uptake on a hybrid positron emission tomography/magnetic resonance imaging (PET/MRI) system in subjects undergoing GAE.
Eligibility Criteria
Inclusion Criteria:
* Provided informed consent
* Age ≥ 40 years
* Ineligibility for or refusal of surgical management
* Moderate-severe knee pain as determined by visual analog scale \> 5 out of 10
* Osteoarthritis based on X-ray. Kellgren-Lawrence score \> 2 based on radiograph completed within 3 months of procedure date
* Resistant/failed some form of conservative treatment (e.g. NSAIDS/physical therapy/steroid joint injection/hyaluronic acid joint injection) for at least 3 months
* Able to comply with all treatments and protocol follow-up visits
Exclusion Criteria:
* Mild knee pain as determined by visual analog scale \< 5 out of 10
* OA on knee radiograph resulting in greater than 20 degree varus or valgus angulation
* Moderate loss of kidney function, define as estimated glomerular filtration rate of less than 45 mL/min.
* Significant arterial atherosclerosis that would limit selective angiography
* History of fibromyalgia, autoimmune, or inflammatory disorder
* History of any lumbar spine surgery, spine injections, or radicular pain in the extremity believed to originate from the spine
* Allergy to iodinated contrast agents
* Active infection or malignancy
* Recent (within 12 months) or active cigarette use
* Prior total or partial knee replacement in the subject knee
* Active pregnancy
* Uncorrectable bleeding diathesis
* Presence of pacemakers, aneurysm clips, neurostimulators, or any other metal implant not compatible with PET/MRI
Source: ClinicalTrials.gov (NCT07494838). StuddyBuddy aggregates publicly available trial information.