Genicular Artery Embolization Vs Observation for Symptomatic Knee Osteoarthritis (GRAVITY)
Knee Osteoarthritis, Degenerative Joint Disease of Knee
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Microspheres, Artery Embolization, Knee Osteoarthritis, Chronic Pain, Embozene
Eligibility Criteria
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
Sites / Locations
- UCLA Santa Monica HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
GAE Treatment
Observational
Subjects will be treated with a genicular artery embolization (GAE) procedure performed with Embozene Microspheres. The microspheres will be delivered in a saline-contrast medium solution and will be delivered to the arteries supplying the areas of the subject's pain.
Subjects randomized to the observational group will not undergo the experimental GAE Treatment. PI will offer subjects enrolled into the observational group to crossover to the experimental GAE Treatment group after they have completed their 6-month follow-up assessments.