Genicular Artery Embolization Vs Observation for Symptomatic Knee Osteoarthritis

NCT04682652 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 22-001004
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical trial is to determine whether genicular artery embolization (GAE) is an effective way to treat knee pain from osteoarthritis. Pain from arthritis is often due to underlying inflammation in the joint. The inflammation is associated with increased abnormal blood flow going to the specific area of pain. If the investigator can reduce the blood flow, the inflammation can be reduced and the pain can be controlled. The GAE procedure is an experimental procedure to decrease the blood flow (embolize) to the specific region of the knee that is causing the pain. This will be done by infusing microscopic spheres into the specific blood vessel (genicular artery) supplying the area of pain in the knee. This is done through a procedure which is called an angiogram, which is done entirely through a pinhole at the creased of the thigh, using twilight (conscious) sedation. The investigators have already completed an initial trial at UCLA, and shown that this procedure is safe and effective. The purpose of this new trial is to compare outcomes of people undergoing the GAE procedure to those who do not undergo the procedure. A total of 120 patients will be enrolled, and 2/3 of the patients will be randomly selected to undergo the GAE procedure. 1/3 will not undergo the procedure. This is known as a randomized trial. During the trial, all subjects will also get MRIs and fluid withdrawn from their knee joints at various timepoints in order to precisely figure out how the procedure works on a closer (microscopic) level.

Conditions

Knee Osteoarthritis; Degenerative Joint Disease of Knee

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Changes in clinical response

  The primary evaluation is the change in clinical response, measured by The Western Ontario and McMaster Universities Arthritis Index (WOMAC). The primary endpoint is percentage of subjects achieving at least a 50% reduction in WOMAC at 6 months with an intent-to-treat analysis.

  6 months

Secondary Outcomes (7)

• Short term clinical outcomes

  1-3 months

• Clinic outcomes at multiple timepoints

  1-24 months

• Degree of change in clinical outcomes via WOMAC

  1-24 months

• Decrease in pain

  1-24 months

• Change in quality of life

  1-24 months

Other Outcomes (6)

• Changes in imaging

  0-24 months

• Changes in inflammatory markers per ng/mL

  0-24 months

• Changes in inflammatory markers per pg/mL

  0-24 months

Study Arms (2)

GAE Treatment

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

Observational

NO INTERVENTION

Subjects randomized to the observational group will not undergo the experimental GAE Treatment. PI will offer subjects enrolled into the observational group to crossover to the experimental GAE Treatment group after they have completed their 6-month follow-up assessments.

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 Treatment

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 less than 80 years
• Ineligibility for or refusal of surgical management
• Moderate-severe knee pain as determined by visual analog scale \> 5 out of 10
• Osteoarthritis based on X-ray. Kellgren-Lawrence score \> 2 based on radiograph completed within 3 months of procedure date.
• Resistant/failed conservative treatment (e.g. NSAIDS/physical therapy/steroid joint injection/ hyaluronic acid joint injection) for at least 3 months
• Able to comply with all treatments and protocol follow-up visits

You may not qualify if:

• Mild knee pain as determined by visual analog scale \< 5 out of 10
• OA on knee radiograph resulting in greater than 20 degree varus or valgus angulation
• Moderate loss of kidney function, define as estimated glomerular filtration rate of less than 45 mL/min.
• Significant arterial atherosclerosis that would limit selective angiography
• History of fibromyalgia, autoimmune, or inflammatory disorder
• History of any lumbar spine surgery, spine injections, or radicular pain in the extremity believed to originate from the spine
• Allergy to iodinated contrast agents
• Active Infection or malignancy
• Recent (within 12 months) or active nicotine use
• Prior total or partial knee replacement in the subject knee
• Active pregnancy
• Uncorrectable bleeding diasthesis
• Other medical, social, or psychological/physical conditions that, in the opinion of the investigator, preclude the patient from participating in the study.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Varian Medical Systems: collaborator

Study Sites (1)

UCLA Santa Monica Hospital

Santa Monica, California, 90404, United States

Location

Related Publications (1)

• Padia SA, Genshaft S, Blumstein G, Plotnik A, Kim GHJ, Gilbert SJ, Lauko K, Stavrakis AI. Genicular Artery Embolization for the Treatment of Symptomatic Knee Osteoarthritis. JB JS Open Access. 2021 Oct 21;6(4):e21.00085. doi: 10.2106/JBJS.OA.21.00085. eCollection 2021 Oct-Dec.

  PMID: 34703964 BACKGROUND

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

Study Officials

• Siddharth A Padia, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A total of 120 subjects will be enrolled in the double-arm study, subjects will be randomized to GAE or observation in a 2:1 ratio (80 assigned to GAE, 40 assigned to observational). Subjects in the observation group will have the option to crossover to the GAE treatment arm after they've completed their 6-month follow-up time point. Subjects who crossover to treatment arm will undergo the GAE procedure and undergo all subsequent follow-up visits (1 month, 3 month, 6 month, 12 month, 24 month).

Study Record Dates

• First Submitted: December 14, 2020
• First Posted: December 24, 2020
• Study Start: August 1, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Unending: Beginning 1 year after publication with no end date.
• Access Criteria: A statistical analysis plan has been created. All de-identified IPD will be stored on a HIPAA compliant online database, that is only accessible by delegated study team members.

Locations

US (1)