Arterial Embolization for Osteoarthritis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called Embozene™ Microspheres, a type of arterial embolization, to determine if it can safely alleviate symptoms in people with knee osteoarthritis (OA). The goal is to see if this procedure can reduce knee pain by blocking certain blood vessels that supply the painful area. In this single-group study, all participants will receive the treatment and be monitored for a year. Individuals with knee OA experiencing moderate to severe pain, despite trying other treatments like painkillers or physical therapy, might be suitable candidates. As an unphased trial, this study provides a unique opportunity to explore a novel treatment option for knee OA.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, it mentions that knee pain should be resistant to conservative treatments like anti-inflammatory drugs, which suggests you might continue some medications. Please consult with the trial coordinators for specific guidance.
What prior data suggests that this arterial embolization technique is safe for osteoarthritis patients?
Research has shown that genicular artery embolization (GAE) using Embozene™ Microspheres is generally safe for treating knee osteoarthritis (OA). Studies have found that patients with mild to moderate knee OA tolerate these microspheres well. One study indicated that GAE with these permanent microspheres is safe and may be effective in the early stages. Another study examined the safety of GAE over two years and confirmed its safety for a different group of patients. Overall, this research suggests that GAE is a promising option for reducing knee pain in individuals who haven't found relief with other treatments or aren't suitable for surgery.12345
Why are researchers excited about this trial?
Researchers are excited about Embozene™ Microspheres for osteoarthritis (OA) because they offer a novel way to manage the condition by targeting the blood vessels. Unlike standard treatments such as pain relievers and physical therapy, which focus on symptoms, this approach uses tiny beads to block abnormal blood vessels in the knee. This can reduce inflammation and pain more directly. The potential to improve symptoms with a minimally invasive procedure makes it a promising option for OA patients.
What evidence suggests that this embolization technique is effective for knee osteoarthritis?
Research has shown that genicular artery embolization (GAE), using Embozene™ Microspheres, can help treat knee osteoarthritis (OA). Studies have found that this treatment leads to lasting improvements in symptoms for individuals with mild to moderate knee OA. Specifically, one study found that participants experienced less pain and improved knee function after the procedure. Another study reported that GAE is safe and offers benefits soon after treatment. Overall, evidence supports that Embozene™ Microspheres effectively reduce knee pain and improve movement in individuals with knee OA. Participants in this trial will receive the Embozene™ Microspheres treatment to further evaluate its effectiveness and safety.12346
Who Is on the Research Team?
Bedros Taslakian, MD
Principal Investigator
NYU Langone Health
Are You a Good Fit for This Trial?
This trial is for adults aged 30-80 with knee pain from osteoarthritis that hasn't improved after trying things like anti-inflammatory drugs, physical therapy, or injections for at least 3 months. They should have a certain level of pain and no major knee surgeries recently. People over 200 Kg, pregnant women, those with serious health issues like cancer or bad kidney function can't join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive geniculate artery embolization using Embozene™ Color-Advanced Microspheres
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Embozene™ Microspheres
Find a Clinic Near You
Who Is Running the Clinical Trial?
NYU Langone Health
Lead Sponsor