Phase
Condition
Osteoarthritis
Knee Injuries
Treatment
Embosphere Microspheres
Clinical Study ID
Ages 40-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 kneeosteoarthritis, which may include one or more of: a) Oral or topical NSAIDS, opioid medications, intra-articular injection ofglucocorticoids 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
Exclusion Criteria:
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 contraindicationto embolization
Active malignancy other than non-melanomatous skin cancer
Subject is pregnant, breastfeeding, or pre-menopausal and intending to becomepregnant
Any other condition related to the subject's health and wellbeing deemedexclusionary in the opinion of the investigator
Study Design
Connect with a study center
University of Miami
Miami, Florida 33136
United StatesActive - Recruiting
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