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

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

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.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis; Degenerative Joint Disease of Knee
• Intervention / Treatment: Device: Embozene MicroSpheres

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Monica, California, United States, 90404
      • Siddharth Padia, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 77 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Experiencing Treatment-related Adverse Events, as a Measure of Safety	Treatment-related AEs from gennicular artery embolization during the study period	Up to 12 Months after GAE

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) as a Measure of Efficacy	The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a self-administered questionnaire consisting of 24 items divided into 3 subscales. Each item is scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). With a total possible range of 0-96, higher scores indicate worse pain, stiffness, and functional limitations. Pain (5 items, possible range 0-20): during walking, using stairs, in bed, sitting or lying, and standing upright Stiffness (2 items, possible range 0-8): after first waking and later in the day Physical Function (17 items, possible range 0-68): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties	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	The WOMAC Pain Subscale is a self-administered questionnaire of 5 items to assess Pain: during walking, using stairs, in bed, sitting or lying, and standing upright. Each item is scored on a scale of 0-4: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4), with a possible total score range of 0-20.	Baseline, Month 1, Month 3, Month 6, Month 12
Change From Baseline in Visual Analog Scale (VAS) as a Measure of Efficacy	The patient-reported severity of knee pain was quantified using a visual analog scale (VAS) score ranging from 0 (indicating no pain) through 10 (indicating the worst pain imaginable).	Baseline, Month 1, Month 3, Month 6, Month 12

Collaborators and Investigators

• Sponsor: Siddharth Padia, MD
• Collaborators: Boston Scientific Corporation
• Investigators: Principal Investigator: Siddharth Padia, M.D., University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2019
• Primary Completion (Actual): October 29, 2021
• Study Completion (Actual): October 29, 2021

Study Registration Dates

• First Submitted: March 23, 2018
• First Submitted That Met QC Criteria: April 5, 2018
• First Posted (Actual): April 9, 2018

Study Record Updates

• Last Update Posted (Actual): November 30, 2022
• Last Update Submitted That Met QC Criteria: November 7, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Chronic Pain; Knee Osteoarthritis; Microspheres; Artery Embolization; Embozene
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Joint Diseases
• Other Study ID Numbers: 18-000560

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes