Trans Arterial Embolization for Facet Arthropathy
Northwell Health
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.
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 fa…
Eligibility
- Age range
- 18–85 years
- Sex
- All
- Healthy volunteers
- No
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 Exclu…
Interventions
- DeviceSpinal 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.
Location
- North Shore University HospitalManhasset, New York