Health TrialsbyHealthPanel

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

ConditionsFacet Joint ArthropathyPainOsteoarthritis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorNorthwell Health

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

- 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)

Trial design

Design model

Single group

Treatments tested in this trial

  • Spinal angiography and embolization/ Embozene Microspheres

    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.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Embozene Microspheres for Facetogenic Low Back PainExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northwell Health

Lead sponsor

Source ClinicalTrials.gov
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