Knee Osteoarthritis
Conditions
Brief summary
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.
Interventions
DEVICEEmbosphere Microspheres
Embosphere Microspheres are 100-300μm small, compressible, hydrophilic, biocompatible spheres made of acrylic polymer and porcine-derived gelatin used for embolization of geniculate artery.
Sponsors
University of Miami
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in knee pain as assessed by the WOMAC | Baseline, 24 Weeks (Post Embolization Surgery) | 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. |
| Incidence of treatment related adverse events | Up to 4 weeks (Post Embolization Surgery) | Procedure-related and target knee osteoarthritis-related adverse events as assessed by treating physician |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events | Up to 52 weeks (Post Embolization Surgery) | Procedure-related and target knee osteoarthritis-related adverse events as assessed by treating physician |
| Change in knee pain as assessed by VAS | Baseline, up to 52 weeks (Post Embolization Surgery) | Visual Analog Scale (VAS) has a total score ranging from 0-10 with the higher score indicating greater pain |
| Kellgren-Lawrence Grade | Baseline, up to 52 weeks (Post Embolization Surgery) | As assessed by X-Ray. Radiograph imaging graded on scale 1 (no arthritis) to 4 (severe arthritis) |
| WORMS Score for Synovitis | Baseline, up to 52 weeks (Post Embolization Surgery) | Whole-Organ Magnetic Resonance Imaging Score (WORMS) has a score ranging from zero representing no knee problems and 332 representing knee problems |
| Change in knee pain | Baseline, up to 52 weeks (Post Embolization Surgery) | 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. |
Countries
United States
Outcome results
None listed