Safety and Efficacy of Genicular Artery Embolization for the Treatment of Symptomatic Knee Osteoarthritis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Number of Participants Experiencing Treatment-related Adverse Events, as a Measure of Safety
Study Overview
Brief Summary
The purpose of this clinical research study is to examine whether Embozene treatment of the genicular artery is a safe and effective way to treat arthritic knee pain. Embozene is a medical device made by Boston Scientific approved in the United States for the treatment of hypervascular tumors and arteriovenous malformations. It consists of thousands of microscopic spheres that are injected into the artery in the knee going to the region of pain. One of the causes of pain in the setting of knee arthritis is increased blood flow going to the specific area of pain. The goal of this procedure is to decrease the blood flow (embolize) to the specific region of the knee that is causing your pain. This is done by infusing Embozene particles into the specific blood vessel (genicular artery) supplying the area of pain in the knee.
Detailed Description
This is a phase 2, single-center, prospective, single arm investigational study to evaluate the safety and efficacy of genicular artery embolization (GAE) for treatment of symptomatic knee osteoarthritis (OA). 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. The primary objective of this investigation is to assess safety of genicular artery embolization (GAE) for knee osteoarthritis (OA) using Embozene particles.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 79 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Provided informed consent
- •Age ≥ 40 years and ≤ 80 years
- •Life expectancy greater than 12 months
- •Ineligibility for or refusal of surgical management
- •Moderate-severe knee pain as determined by visual analog scale > 4
- •Osteoarthritis based on xray
- •Local knee tenderness
- •Resistant/failed conservative treatment (e.g. NSAIDS/physical therapy/steroid joint injection)
Exclusion Criteria
- •Mild knee pain as determined by visual analog scale < 4
- •Chronic renal insufficiency (serum creatinine >2 mg/dL)
- •Uncorrectable bleeding diathesis: international normalized ratio (INR) >1.6, Platelets <50,000
- •Significant arterial atherosclerosis that would limit selective angiography
- •Allergy to iodinated contrast agents that is not responsive to steroid management
- •Active Infection or malignancy
- •Appropriate candidate for knee replacement surgery determined by clinical and physical examination
- •Recent (within 3 months) or active cigarette use
Arms & Interventions
GAE OA
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.
Intervention: Embozene MicroSpheres (Device)
Outcomes
Primary Outcomes
Number of Participants Experiencing Treatment-related Adverse Events, as a Measure of Safety
Time Frame: Up to 12 Months after GAE
Treatment-related AEs from gennicular artery embolization during the study period
Secondary Outcomes
- Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) as a Measure of Efficacy(Baseline, Month 1, Month 3, Month 6, Month 12)
- Change From Baseline in Visual Analog Scale (VAS) as a Measure of Efficacy(Baseline, Month 1, Month 3, Month 6, Month 12)
- Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain Subscale as a Measure of Efficacy(Baseline, Month 1, Month 3, Month 6, Month 12)
Investigators
Siddharth Padia, MD
Principal Investigator
University of California, Los Angeles