Genicular Artery Embolization for the Treatment of Knee Osteoarthritis (GAE-OA)

Siddharth Padia, MD

Status: Completed

Conditions: Degenerative Joint Disease of Knee; Knee Osteoarthritis

Treatments: Device: Embozene MicroSpheres

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03491397

18-000560

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 40 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

GAE OA

Experimental group

Description:

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.

Treatment:

Device: Embozene MicroSpheres