Using Embosphere Microspheres to Treat Knee Pain from Osteoarthritis
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
NA · University of Miami · NCT05112926
This study is testing whether a new treatment using tiny microspheres can help people aged 40 to 80 with knee pain from osteoarthritis feel better when other treatments haven't worked.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Sponsor | University of Miami (other) |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT05112926 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness and safety of Embosphere Microspheres for embolizing the geniculate artery in patients suffering from moderate to severe knee osteoarthritis. Participants will be individuals aged 40 to 80 who have not responded to conservative treatments for at least 12 weeks. The study aims to assess pain relief and functional improvement through this innovative approach to managing knee osteoarthritis. The intervention involves a minimally invasive procedure using embolic microspheres to target pain pathways.
Who should consider this trial
Good fit: Ideal candidates are adults aged 40-80 with moderate to severe knee osteoarthritis who have not found relief from previous conservative therapies.
Not a fit: Patients with rheumatoid arthritis, severe osteoarthritis (Kellgren-Lawrence grade >3), or those who have undergone knee arthroplasty may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide significant pain relief and improved function for patients with knee osteoarthritis.
How similar studies have performed: While this approach is innovative, similar studies using embolization techniques for pain management have shown promise, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Miami, Florida
- University of Miami — Miami, Florida, United States (RECRUITING)
Study contacts
- Principal investigator: Felipe Ferreira De Souza — University of Miami
- Study coordinator: Lia Quezada
- Email: Lquezada@med.miami.edu
- Phone: 305-243-2210
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Knee Osteoarthritis