Effectiveness and Safety of Embosphere Microspheres for Embolization of the Geniculate Artery for the Treatment of Pain With Known Moderate to Severe Knee Osteoarthritis
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Lead
University of Miami
Age
40–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Subject has signed informed consent
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
You may not be if
Rheumatoid arthritis
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
Clareo Health | Effectiveness and Safety of Embosphere Microspheres for Embolization of the Geniculate Artery for the Treatment of Pain With Known Moderate to Severe Knee Osteoarthritis
