RECRUITING

Trans-arterial Embolization for the Treatment of Facet Pain Due to Facet Arthropathy

Description

This single-site, single-arm study evaluates the feasibility, safety, tolerability, and efficacy of trans-arterial embolization (TAE) using Embozene microparticles for treating facetogenic pain due to facet arthropathy (osteoarthritis of the facet joints) in the lumbar spine.

Conditions

Facet Joint ArthropathyPainOsteoarthritis
Talk to us

Related Conditions:

Facet Joint ArthropathyPainOsteoarthritis

Study Overview

On this page

Study Details

Study overview

This single-site, single-arm study evaluates the feasibility, safety, tolerability, and efficacy of trans-arterial embolization (TAE) using Embozene microparticles for treating facetogenic pain due to facet arthropathy (osteoarthritis of the facet joints) in the lumbar spine.

Trans Arterial Embolization for Facet Arthropathy

Trans-arterial Embolization for the Treatment of Facet Pain Due to Facet Arthropathy

Condition
Facet Joint Arthropathy
Intervention / Treatment

-

Contacts and Locations

Manhasset

North Shore University Hospital, Manhasset, New York, United States, 11030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Age 18-85
  • * Confirmed diagnosis of spinal facet arthropathy on MRI OR CT
  • * Confirmed diagnosis of lumbosacral facetogenic pain based on diagnostic nerve blocks.
  • * Failed medical management of pain.
  • * Back pain persistent for at least 6 months
  • * Pain worse than at least 6/10 on a visual analog pain scale
  • * Failed at least one of either intra-articular injections of steroids/ anesthetics or neuro-ablative procedure.
  • * Maximum of 2 spinal levels of facetogenic pain in the lumbar and sacral spine (i.e. L4-5 and L5-S1).
  • * Modified Rankin Scale 0-2
  • * - Pregnancy
  • * History of prior spinal embolization at the target level.
  • * History of surgery/ stenting of the aorta at the level of embolization.
  • * Severe allergic reaction to iodinated contrast (i.e. anaphylaxis)
  • * Creatinine \> 1.5 mg/dl and/or creatinine clearance \< 60 mL/min (except if patients is already on hemodialysis).
  • * Modified Rankin Scale \>2
  • * Angiographic/ Procedural Exclusion Criterion: Vascular supply to the spinal cord from the vessels supplying the facet joints targeted for embolization.

Ages Eligible for Study

18 Years to 85 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Northwell Health,

Study Record Dates

2026-08-01