Arterial Embolization for Osteoarthritis

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Overseen ByDanibel Ramos
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: NYU Langone Health
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

BT

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

My knee pain hasn't improved after 3 months of standard treatments.
I am between 30 and 80 years old.
My knee X-ray shows moderate to severe arthritis without bone deformity.
See 2 more

Exclusion Criteria

My knee injury happened within the last year or involved a fracture.
Life expectancy less than 12 months
I currently have a knee infection.
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive geniculate artery embolization using Embozene™ Color-Advanced Microspheres

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months
4 visits (in-person) at 1 month, 3 months, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Embozene™ Microspheres
Trial Overview The study tests if blocking blood flow to the knee using Embozene™ Microspheres through an artery can help with osteoarthritis pain. It's a single-group trial without a placebo where patients are monitored for one year to see how safe and effective this treatment is.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Embolization GroupExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials
1,431
Recruited
838,000+

Published Research Related to This Trial

Transcatheter arterial embolization was performed on 14 patients with mild to moderate knee osteoarthritis, resulting in significant pain relief as measured by the WOMAC pain scores, which improved from 12.2 to 3.3 at 1 month and further to 1.7 at 4 months.
The procedure was safe, with no major adverse events reported, and the improvements in pain and function were maintained for up to 19 months after treatment.
Transcatheter arterial embolization as a treatment for medial knee pain in patients with mild to moderate osteoarthritis.Okuno, Y., Korchi, AM., Shinjo, T., et al.[2015]
Bland embolization using microspheres provided effective pain relief for 90% of the 20 patients with painful malignant musculoskeletal tumors, indicating its efficacy in managing pain associated with these tumors.
The procedure was generally safe, with only 20% of patients experiencing grade-3 adverse events, and no severe complications (grade-4 or grade-5), suggesting it is a viable option for pain management in this patient population.
Clinical Utility of Bland Embolization Using Microspheres for Painful Malignant Musculoskeletal Tumors.Taniguchi, J., Takaki, H., Kodama, H., et al.[2023]
Genicular artery embolization (GAE) using permanent microspheres in 38 patients with mild to moderate knee osteoarthritis showed significant pain reduction, with mean visual analogue scale (VAS) scores improving from 60 at baseline to 36 at 3 months and 45 at 1 year.
The procedure was found to be safe, with only mild self-limiting adverse events reported, and significant improvements in knee MRI scores and patient-reported outcomes, indicating potential efficacy for managing knee osteoarthritis.
Genicular artEry embolizatioN in patiEnts with oSteoarthrItiS of the Knee (GENESIS) Using Permanent Microspheres: Interim Analysis.Little, MW., Gibson, M., Briggs, J., et al.[2021]

Citations

Two-year outcomes comparing Embosphere ...Embosphere Microspheres can be considered a safe and effective embolic agent for GAE for treating moderate to severe knee osteoarthritis with sustained outcomes ...
Genicular artEry embolizatioN in patiEnts with ...Conclusion. GAE using permanent microspheres in patients with mild to moderate knee OA is safe, with potential efficacy at early follow-up.
Genicular Artery Embolization for Treatment of ...The primary end point was treatment effectiveness as measured by sustained improvement in OA symptoms at 24 months, quantified using the Western ...
Genicular Artery Embolization for the Treatment of Knee ...The primary objective of this investigation is to assess safety of genicular artery embolization (GAE) for knee osteoarthritis (OA) using Embozene particles.
Genicular artery embolization for knee osteoarthritisIn patients with mild to moderate knee OA, GAE results in symptomatic improvement greater than the sham procedure with clinically significant reduction in pain ...
Safety and Efficacy of Genicular Artery Embolization for ...GAE appears to be a promising option for knee OA pain, particularly for patients unresponsive to conservative treatments or ineligible for surgery.
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