Summary

Eligibility
for people ages 40-79 (full criteria)
Location
at UCLA
Dates
study started
estimated completion
Principal Investigator
by Siddharth Padia, M.D. (ucla)

Description

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.

Official Title

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

Details

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.

Keywords

Knee Osteoarthritis Degenerative Joint Disease of Knee Microspheres Artery Embolization Chronic Pain Embozene Osteoarthritis Osteoarthritis, Knee Joint Diseases Embozene MicroSpheres GAE OA

Eligibility

You can join if…

Open to people ages 40-79

  • 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)

You CAN'T join if...

• 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

Location

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

Lead Scientist at University of California Health

  • Siddharth Padia, M.D. (ucla)
    HS Clinical Professor, Radiological Sciences. Authored (or co-authored) 68 research publications.

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Siddharth Padia, MD
ID
NCT03491397
Study Type
Interventional
Last Updated