The purpose of this research study is to evaluate the effectiveness and safety of a permanent embolic (Embosphere Microspheres) for embolization of the geniculate artery for the treatment of moderate to severe knee osteoarthritis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Embosphere Microspheres are 100-300μm small, compressible, hydrophilic, biocompatible spheres made of acrylic polymer and porcine-derived gelatin used for embolization of geniculate artery.
University of Miami
Miami, Florida, United States
Change in knee pain as assessed by the WOMAC
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain index assesses participants' pain on a scale ranging from 0 (none) to 4 (extreme). The pain subscale consists of 5 items and total scores can range from 0-20, with larger scores indicating greater pain.
Time frame: Baseline, 24 Weeks (Post Embolization Surgery)
Incidence of treatment related adverse events
Procedure-related and target knee osteoarthritis-related adverse events as assessed by treating physician
Time frame: Up to 4 weeks (Post Embolization Surgery)
Change in knee pain as assessed by VAS
Visual Analog Scale (VAS) has a total score ranging from 0-10 with the higher score indicating greater pain
Time frame: Baseline, up to 52 weeks (Post Embolization Surgery)
Change in knee pain
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain index assesses participants' pain on a scale ranging from 0 (none) to 4 (extreme). The pain subscale consists of 5 items and total scores can range from 0-20, with larger scores indicating greater pain.
Time frame: Baseline, up to 52 weeks (Post Embolization Surgery)
Incidence of adverse events
Procedure-related and target knee osteoarthritis-related adverse events as assessed by treating physician
Time frame: Up to 52 weeks (Post Embolization Surgery)
WORMS Score for Synovitis
Whole-Organ Magnetic Resonance Imaging Score (WORMS) has a score ranging from zero representing no knee problems and 332 representing knee problems
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Time frame: Baseline, up to 52 weeks (Post Embolization Surgery)
Kellgren-Lawrence Grade
As assessed by X-Ray. Radiograph imaging graded on scale 1 (no arthritis) to 4 (severe arthritis)
Time frame: Baseline, up to 52 weeks (Post Embolization Surgery)