Genicular Artery Embolization for the Treatment of Knee Osteoarthritis

NCT03491397 | Completed Results DMC FDA Device

• 1 other identifier: 18-000560
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis; Degenerative Joint Disease of Knee

Keywords

Microspheres; Artery Embolization; Knee Osteoarthritis; Chronic Pain; Embozene

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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 Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain Subscale 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

Study Arms (1)

GAE OA

EXPERIMENTAL

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

Interventions

Embozene MicroSpheres DEVICE

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.

Also known as: Color-Advanced Microspheres, Microspheres for Embolization

GAE OA

Eligibility Criteria

• Age: 40 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Siddharth Padia, MD: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

Siddharth Padia, M.D.

Santa Monica, California, 90404, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Chronic Pain

Interventions

Microspheres; Embolization, Therapeutic

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Equipment and Supplies; Hemostatic Techniques; Therapeutics; Therapeutic Occlusion

Results Point of Contact

• Title: Siddharth A. Padia, MD
• Organization: University of California Los Angeles

SPadia@mednet.ucla.edu

310-825-2992

Study Officials

• Siddharth Padia, M.D.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: March 23, 2018
• First Posted: April 9, 2018
• Study Start: February 10, 2019
• Primary Completion: October 29, 2021
• Study Completion: October 29, 2021
• Last Updated: November 30, 2022
• Results First Posted: November 30, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)