Effectiveness and Safety of Embosphere Microspheres for Embolization of the Geniculate Artery for the Treatment of Pain With Known Moderate to Severe Knee Osteoarthritis
NCT ID: NCT05112926
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
9 participants
INTERVENTIONAL
2022-12-08
2025-10-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Embosphere Microspheres group
Participants in this group who are receiving standard of care (SOC) embolization surgery for the treatment of moderate to severe knee osteoarthritis will receive the Embospheres Microspheres during scheduled SOC surgery.
Embosphere Microspheres
Embosphere Microspheres are 100-300μm small, compressible, hydrophilic, biocompatible spheres made of acrylic polymer and porcine-derived gelatin used for embolization of geniculate artery.
Interventions
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Embosphere Microspheres
Embosphere Microspheres are 100-300μm small, compressible, hydrophilic, biocompatible spheres made of acrylic polymer and porcine-derived gelatin used for embolization of geniculate artery.
Eligibility Criteria
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Inclusion Criteria
* Subject is age 40-80
* Subject is able to have an MRI
* Minimum of prior 12 weeks of failed response to conservative therapy for knee osteoarthritis, which may include one or more of:
a) Oral or topical NSAIDS, opioid medications, intra-articular injection of glucocorticoids or hyaluronic acid, physical therapy.
* Localized tenderness in anterior knee area
* Kellgren-Lawrence grade 1, 2, or 3 as assessed by weight-bearing knee radiographs
* Synovitis present as assessed by WORMS
* VAS \>50 mm
* WOMAC score \>30
Exclusion Criteria
* Local infection of the target knee(s)
* Kellgren-Lawrence grade \>3
* Osteonecrosis evident by MRI
* Prior knee arthroplasty
* Allergy to iodinated contrast agents that cannot be managed by prophylaxis
* Hypersensitivity to gelatin products
* Any known condition that limits catheter-based intervention or is a contraindication to embolization
* Active malignancy other than non-melanomatous skin cancer
* Subject is pregnant, breastfeeding, or pre-menopausal and intending to become pregnant
* Any other condition related to the subject's health and wellbeing deemed exclusionary in the opinion of the investigator
40 Years
80 Years
ALL
No
Sponsors
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University of Miami
OTHER
Responsible Party
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Felipe Ferreira De Souza
Assistant Professor of Clinical Radiology
Principal Investigators
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Felipe Ferreira De Souza
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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University of Miami
Miami, Florida, United States
Countries
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Other Identifiers
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20210848
Identifier Type: -
Identifier Source: org_study_id