Facet Joint ArthropathyNCT06965452
Trans-arterial Embolization for the Treatment of Facet Pain Due to Facet Arthropathy
A study testing Spinal angiography and embolization/ Embozene Microspheres in people with Facet Joint Arthropathy and Pain, run by Northwell Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Facet Joint Arthropathy, Pain, Osteoarthritis
- What is being tested?
- Spinal angiography and embolization/ Embozene Microspheres
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2025to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- - 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
North Shore University Hospital
Manhasset, New York, 11030
Betsy Moclair, 516-253-7753, bmoclair@northwell.edu
About this study
Official title: Trans Arterial Embolization for Facet Arthropathy
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.
Read the 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
- Being tested
- Spinal angiography and embolization/ Embozene Microspheres
- Keywords
- Facetogenic pain, Facet pain, Facet joint pain, Low back pain, Back Pain
- Medical subject headings
- Pain, Osteoarthritis, Low Back Pain, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal angiography and embolization/ Embozene MicrospheresDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Embozene Microspheres for Facetogenic Low Back Pain | Experimental | 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. Receives: Device: Spinal angiography and embolization/ Embozene Microspheres |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (2)
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
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2025
- Study start12 Aug 2025
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facet Joint ArthropathyStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The intervention consists of a trans-arterial injection of the vascular supply the facet joints using Embozene microspheres. After patients have failed conservative management with proven facetogenic pain they will be enrolled into the study. Patients will be brought to the neurointerventional suite and have a diagnostic spinal angiogram under procedural sedation. The dorsal segmental arteries supplying the facet joints causing back pain will be embolized using Embozene microspheres approved particles.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Athos Patsalides, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06965452
- Sponsor's protocol ID
- 23-1020
- Status last verified
- Aug 2026
- First submitted
- 23 Apr 2025
- Last updated
- 30 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trans Arterial Embolization for Facet Arthropathy
- ClinicalTrials.gov ID
- NCT06965452
- Acronym / sponsor ID
- 23-1020
- Conditions
- Facet Joint Arthropathy, Pain, Osteoarthritis
- Keywords
- Facetogenic pain, Facet pain, Facet joint pain, Low back pain, Back Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 12 Aug 2025 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 11 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The intervention consists of a trans-arterial injection of the vascular supply the facet joints using Embozene microspheres. After patients have failed conservative management with proven facetogenic pain they will be enrolled into the study. Patients will be brought to the neurointerventional suite and have a diagnostic spinal angiogram under procedural sedation. The dorsal segmental arteries supplying the facet joints causing back pain will be embolized using Embozene microspheres approved particles.
| Arm | Type | Receives |
|---|---|---|
| Embozene Microspheres for Facetogenic Low Back Pain | Experimental | Device: Spinal angiography and embolization/ Embozene MicrospheresThis 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18-85
Key exclusion criteria (7 listed)
- - 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal angiography and embolization/ Embozene MicrospheresOnce 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. | Device | Embozene Microspheres for Facetogenic Low Back Pain |
Primary outcome
Number of Procedure-Related Serious Adverse Events in the Perioperative Period
Time frame: 1 year
The primary outcome measurements for safety are: -The number of procedure-related serious adverse events occurring in the perioperative period
2 secondary outcomes
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.
Time frame: 1 year
Proportion of Patients with >20% Improvement in Disability Based on Oswestry Low Back Pain Disability Questionnaire
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Athos Patsalides, MD principal investigator
Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal angiography and embolization/ Embozene Microspheres in people with Facet Joint Arthropathy and Pain, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Betsy Moclair (516-253-7753, bmoclair@northwell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Procedure-Related Serious Adverse Events in the Perioperative Period (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.