An interventional study of Spinal angiography and embolization/ Embozene Microspheres in Facet Joint Arthropathy, Pain and Osteoarthritis, sponsored by Northwell Health. Recruiting at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Northwell Health · Not applicable, Interventional, and Treatment
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.
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.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's planned enrollment of 40 is below the median of 66 across 8,493 interventional studies indexed under Pain.
Browse Pain studies →Northwell Health is the lead sponsor of 475 studies on the registry; 107 are open to participants now.
Of its 45 completed or terminated interventional studies of FDA-regulated products, 23 (51%) have results posted.
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Age 18-85
Failed medical management of pain.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Number of Procedure-Related Serious Adverse Events in the Perioperative Period
The primary outcome measurements for safety are: -The number of procedure-related serious adverse events occurring in the perioperative period
Time frame: 1 year
Proportion of Patients with >20% Improvement in Facetogenic Pain Based on Visual Analog Scale (VAS). Percent from 0% to 100% and higher % represents greater improvement.
Secondary endpoints include: \- \>20% improvement of facetogenic pain based on visual analog pain scale before and after the procedure
Time frame: 1 year
Proportion of Patients with >20% Improvement in Disability Based on Oswestry Low Back Pain Disability Questionnaire
Secondary endpoints include:- \>20% improvement in disability based on Oswestry Low Back Pain Disability Questionnaire.Percent from 0% to 100% and higher % represents greater improvement.
Time frame: 1 year
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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