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

Sponsor

Siddharth Padia, MD (Other)

Overall Status

Completed

CT.gov ID

NCT03491397

Collaborator

Boston Scientific Corporation (Industry)

Enrollment

Location

Arm

32.6

Actual Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis Degenerative Joint Disease of Knee	Device: Embozene MicroSpheres	N/A

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

Actual Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

The stratification will not be randomized, but each category will be limited to 20 patients.The stratification will not be randomized, but each category will be limited to 20 patients.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Safety and Efficacy of Genicular Artery Embolization for the Treatment of Symptomatic Knee Osteoarthritis

Actual Study Start Date :

Feb 10, 2019

Actual Primary Completion Date :

Oct 29, 2021

Actual Study Completion Date :

Oct 29, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: Embozene MicroSpheres 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. Other Names: Color-Advanced Microspheres Microspheres for Embolization

Arm

Intervention/Treatment

Experimental: 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.

Device: Embozene MicroSpheres

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.

Other Names:

Color-Advanced Microspheres

Microspheres for Embolization

Outcome Measures

Primary Outcome Measures

Safety evaluated by cumulative rates of Adverse Events [12 Months]
Cumulative rates of AEs will be estimated and will be reported. AEs will be analyzed as a composite of all AEs, composites based on major AE types or severity and as individual AE types.

Secondary Outcome Measures

Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) as a measure of efficacy [12 Months]
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a widely used, proprietary set of 17 standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints.
Changes in Visual Analog Scan (VAS) as a measure of efficacy [12 Months]
The Faces Pain Scale is a numerical self-report measure of pain intensity developed for children to score the sensation of pain from 0-10. Pictures of 6 cartoon faces ranging from neutral expression of "no pain" (0) to "very much pain" (10). Participant is asked to point to the face that shows how much participant hurts at the time of assessment.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 79 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Provided informed consent
Age ≥ 40 years and less than 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: 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