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

NCT ID: NCT06965452

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-12
• Study Completion Date: 2026-08-01

Brief Summary

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.

Detailed Description

This is a single site, single-arm study assessing the feasibility, safety, tolerability, and efficacy of trans-arterial embolization for the treatment of facet pain due to facet arthropathy. Osteoarthritis is a common and major cause of pain and disability. Each spinal level contains multiple joints including the intervertebral discs as well as the facet joints. Degeneration of the facet joints or facet arthritis begins early in life and the prevalence grows with increasing age ultimately reaching as high as 100% in people over 60 years of age. Facet arthritis can lead to the development of facetogenic pain. Previous studies have suggested that trans-arterial embolization may be beneficial for pain in the setting of osteoarthritis. Trans-arterial injections have been described in the knee, hip, and shoulder.

Embolization of the dorsal branches of the segmental arteries supplying the bony elements of the spine is a well-established technique employed for preoperative embolization of bony spinal tumors and metastatic disease. Previous studies have clearly demonstrated safety of the techniques with low overall risk. In one large series of 100 embolizations there was only one recorded complication due to the embolization. However, it has not been described for use in the setting of facet arthropathy (OA of the facet joint). The PI for this study has published the results of large series of embolization for spinal tumors without any serious adverse events. Currently the treatment of lumbar spine OA involved medical management, followed by minimally invasive techniques such as intraarticular injection and neurolysis, which are of questionable efficacy, and ultimately possible spinal surgery and fusion in the setting of degenerative disease and structural abnormalities. The purpose of this study is to demonstrate the safety and preliminary efficacy of trans-arterial facet joint embolization using Embozene microparticles in patients with facet arthropathy and lumbar spine OA.

Conditions

Facet Joint Arthropathy; Pain; Osteoarthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Embozene Microspheres for Facetogenic Low Back Pain

This is a single site, single arm study to assess the safety and efficacy of trans arterial embolization using Embozene microspheres of the facet joint for the treatment of facetogenic low back pain.

Group Type: EXPERIMENTAL

Spinal angiography and embolization/ Embozene Microspheres

Intervention Type: DEVICE

Once consent is obtained the patient will be scheduled for spinal angiography and embolization. The patient will undergo the procedure at North Shore University Hospital. After embolization the patient will be monitored in recovery for 5 hours and then discharged to home.

The primary objective of this study is to examine the safety and feasibility of trans arterial embolization of the facet joint using Embozene Microspheres for the treatment of back pain from facet arthropathy and osteoarthritis.

Interventions

Spinal angiography and embolization/ Embozene Microspheres

Once consent is obtained the patient will be scheduled for spinal angiography and embolization. The patient will undergo the procedure at North Shore University Hospital. After embolization the patient will be monitored in recovery for 5 hours and then discharged to home.

The primary objective of this study is to examine the safety and feasibility of trans arterial embolization of the facet joint using Embozene Microspheres for the treatment of back pain from facet arthropathy and osteoarthritis.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion 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

Exclusion Criteria

• - 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwell Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

North Shore University Hospital

Manhasset, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Betsy Moclair

Role: CONTACT

bmoclair@northwell.edu

516-253-7753

Facility Contacts

Betsy Moclair

Role: primary

bmoclair@northwell.edu

516-253-7753

Other Identifiers

23-1020

Identifier Type: -

Identifier Source: org_study_id