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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Embosphere Microspheres group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Embosphere Microspheres | Device | Embosphere Microspheres are 100-300μm small, compressible, hydrophilic, biocompatible spheres made of acrylic polymer and porcine-derived gelatin used for embolization of geniculate artery. |
| 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) |
| 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 |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Felipe Ferreira De Souza | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
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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) |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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