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NCT Number: NCT03491397

Genicular Artery Embolization for the Treatment of 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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Chronic Pain Degenerative Joint Disease of Knee Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Osteoarthritis Osteoarthritis, Knee Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

40 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Siddharth Padia, M.D.

Santa Monica, California, 90404, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Color-Advanced Microspheres, Microspheres for Embolization

Primary outcomes

  1. Number of Participants Experiencing Treatment-related Adverse Events, as a Measure of Safety

    Time frame: Up to 12 Months after GAE

    Treatment-related AEs from gennicular artery embolization during the study period

Secondary outcomes

  1. Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) as a Measure of Efficacy

    Time frame: Baseline, Month 1, Month 3, Month 6, Month 12

    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

  2. Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain Subscale as a Measure of Efficacy

    Time frame: Baseline, Month 1, Month 3, Month 6, Month 12

    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.

  3. Change From Baseline in Visual Analog Scale (VAS) as a Measure of Efficacy

    Time frame: Baseline, Month 1, Month 3, Month 6, Month 12

    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).

Sponsors and collaborators

Lead sponsor

Siddharth Padia, MD

Other

Collaborators

  • Boston Scientific Corporation

Registry information

Official study title

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

Acronym: GAE-OA

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 9, 2018
Registry last updated
Nov 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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