Effectiveness and Safety of Embosphere Microspheres for Embolization of the Geniculate Artery for the Treatment of Pain With Known Moderate to Severe Knee Osteoarthritis

Study Overview
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Brief Summary
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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.

Official Title
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Prospective, Single Arm Investigation to Assess Effectiveness and Safety of Embosphere Microspheres for Embolization of the Geniculate Artery for the Treatment of Pain With Known Moderate to Severe Knee Osteoarthritis

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Device: Embosphere Microspheres


Participation Criteria
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Eligibility Criteria
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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 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: 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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Embosphere Microspheres group<br>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. | Device: Embosphere Microspheres<br>* Embosphere Microspheres are 100-300μm small, compressible, hydrophilic, biocompatible spheres made of acrylic polymer and porcine-derived gelatin used for embolization of geniculate artery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | Up to 4 weeks (Post Embolization Surgery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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 | 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 | 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) | Baseline, up to 52 weeks (Post Embolization Surgery) |