Status:
RECRUITING
Genicular Artery Embolization Vs Observation for Symptomatic Knee Osteoarthritis
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
Varian Medical Systems
Conditions:
Knee Osteoarthritis
Degenerative Joint Disease of Knee
Eligibility:
All Genders
40-79 years
Phase:
NA
Brief Summary
The purpose of this clinical trial is to determine whether genicular artery embolization (GAE) is an effective way to treat knee pain from osteoarthritis. Pain from arthritis is often due to underlyin...
Detailed Description
This is a single-center, prospective, open-label randomized trial to compare outcomes of GAE versus observation, and to identify biomarkers and imaging endpoints that change in response to GAE. Subje...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Subjects must meet all of the following inclusion criteria in order to be eligible for this study:
- Provided informed consent
- Age ≥ 40 years and less than 80 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 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
- Subjects that meet any of the following exclusion criteria will not be eligible for this study:
- 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 diasthesis
Exclusion
Key Trial Info
Start Date :
August 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04682652
Start Date
August 1 2023
End Date
October 1 2027
Last Update
October 3 2025
Active Locations (1)
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1
UCLA Santa Monica Hospital
Santa Monica, California, United States, 90404