NCT06965452

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

Trans Arterial Embolization for Facet Arthropathy

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Northwell Health · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2025-08-12
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2025-05-11
• Last updated: 2025-08-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study