Arterial Embolization for Osteoarthritis

Overseen By Danibel Ramos

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Infection, Malignancy, Renal dysfunction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 1 day

38 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Embozene™ Microspheres for osteoarthritis?

Research shows that using microspheres for arterial embolization can relieve pain in patients with knee osteoarthritis, especially when other treatments haven't worked. This method has also been effective in reducing pain from other conditions, like painful tumors, suggesting it might help with osteoarthritis too. ^{1 2 3 4 5}

How does the treatment Embozene™ Microspheres for osteoarthritis differ from other treatments?

Embozene™ Microspheres offer a unique approach by using arterial embolization, which involves blocking blood flow to reduce inflammation and pain in osteoarthritis, unlike traditional treatments that focus on direct joint injections or oral medications. ^{6 7 8 9 10}

What is the purpose of this trial?

This trial is testing a new treatment where tiny beads are used to block certain blood vessels in the knee. It is aimed at people with mild to moderate knee osteoarthritis who might not benefit from usual treatments. The goal is to see if blocking these blood vessels can safely reduce pain and swelling.

Research Team

Bedros Taslakian, MD

Principal Investigator

NYU Langone Health

Eligibility Criteria

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.

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Embolization Group Experimental Treatment 2 Interventions

23 participants who are aged between 30 to 75 years old, with grade 2 or 3 knee OA on the most recent knee radiographs obtained within 6 months of intervention. Each individual participant will be enrolled for approximately 13 months to complete all study visits from the initial screening visit to last follow up at 12-months post intervention.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Utility of Bland Embolization Using Microspheres for Painful Malignant Musculoskeletal Tumors. Taniguchi, J., Takaki, H., Kodama, H., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Genicular artEry embolizatioN in patiEnts with oSteoarthrItiS of the Knee (GENESIS) Using Permanent Microspheres: Interim Analysis. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Midterm Clinical Outcomes and MR Imaging Changes after Transcatheter Arterial Embolization as a Treatment for Mild to Moderate Radiographic Knee Osteoarthritis Resistant to Conservative Treatment. [2017]

3. Greece pubmed.ncbi.nlm.nih.gov

Clinical Utility of Bland Embolization Using Microspheres for Painful Malignant Musculoskeletal Tumors. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Transcatheter arterial embolization as a treatment for medial knee pain in patients with mild to moderate osteoarthritis. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

Assessing the Effects of Geniculate Artery Embolization in a Nonsurgical Animal Model of Osteoarthritis. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Intra-articular drug delivery: the challenge to extend drug residence time within the joint. [2011]

7. Singapore pubmed.ncbi.nlm.nih.gov

Accuracy comparisons of intra-articular knee injection between the new modified anterolateral Approach and superolateral approach in patients with symptomatic knee osteoarthritis without effusion. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Injectable medications for osteoarthritis. [2013]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Intra-Articular Drug Delivery for Osteoarthritis Treatment. [2021]

10. Italy pubmed.ncbi.nlm.nih.gov

Clinical effects of image-guided hyaluronate injections for the osteochondral lesions of ankle in sport active population. [2018]