What side effects are associated with this type of intervention?

Common treatments for osteoarthritis, such as NSAIDs, glucocorticoids, and intraarticular injections, have various side effects. NSAIDs can cause gastrointestinal issues, cardiovascular problems, and kidney damage. Glucocorticoids, when used systemically, may lead to weight gain, osteoporosis, and increased infection risk. Intraarticular injections, while providing short-term relief, can cause joint infection, post-injection flare, and potential cartilage damage. Geniculate Artery Embolization, which reduces blood flow to inflamed areas, may have side effects like post-procedural pain, risk of infection, and potential damage to surrounding tissues. Each treatment should be considered carefully in consultation with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several treatments for osteoarthritis that focus on reducing pain and inflammation. These include nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen and naproxen, corticosteroid injections, and hyaluronic acid injections which provide lubrication to the joint. Additionally, the FDA has approved physical therapy and lifestyle modifications as non-pharmacological treatments. While Geniculate Artery Embolization using Embozene™ Color-Advanced Microspheres is a novel approach focusing on reducing blood flow to inflamed areas, it is still under investigation and not yet FDA-approved.

What other types of research exist?

Promising, novel alternatives to Geniculate Artery Embolization for osteoarthritis patients include: 1) Intra-articular injections of autologous platelet-rich plasma (PRP), which can promote healing and reduce inflammation. 2) Low-level laser therapy (LLLT), which has shown potential in improving symptoms and healing in small studies. 3) Hyaluronic acid injections, which can provide lubrication and pain relief in the joint. 4) Emerging biologic treatments such as stem cell therapy, which aim to regenerate damaged tissue and reduce inflammation. These alternatives offer different mechanisms to manage OA symptoms and may be considered in consultation with a healthcare provider.

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Embolization Agent

Arterial Embolization for Osteoarthritis

Q: What is the mechanism of action of this treatment?

Common treatments for osteoarthritis (OA) work by targeting inflammation and pain. Nonsteroidal anti-inflammatory drugs (NSAIDs) inhibit cyclooxygenase enzymes to reduce inflammatory mediators, thereby alleviating pain and swelling. Corticosteroid injections suppress multiple inflammatory pathways for short-term pain relief. Geniculate artery embolization, an investigational approach, reduces blood flow to inflamed knee areas, potentially decreasing pain and inflammation. Understanding these mechanisms helps OA patients and their doctors choose the most suitable treatment based on individual needs and responses.

N/A

Waitlist Available

Led By Bedros Taslakian, MD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Knee pain resistant to conservative treatment for at least 3 months (anti-inflammatory drugs, acetaminophen, physical therapy, muscle strengthening, or intra-articular injection of hyaluronic acid and/or steroids)

Kellgren-Lawrence Grade 2, 3, or 4 (in select subjects who have no bony deformity) knee OA on most recent knee radiograph obtained within 6 months of screening visit

Must not have

Active systemic or local knee infection

Active malignancy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 1 month, 3 month and 12 month follow up visits

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly listed in the provided information, potential side effects may include discomfort at the injection site, allergic reaction to materials used during embolization (like contrast dye), temporary numbness or tingling due to nerve irritation, and bruising.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My knee pain hasn't improved after 3 months of standard treatments.

Select...

My knee X-ray shows moderate to severe arthritis without bone deformity.

Select...

My knee pain is moderate to severe, scoring 40 or more on a pain scale.

Select...

I can understand and complete English questionnaires.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I currently have a knee infection.

Select...

I currently have cancer.

Select...

I have severe artery blockage that affects blood tests or causes leg pain.

Select...

My kidney function is impaired, with creatinine >1.6 or eGFR <60.

Select...

I have avascular necrosis in my knee.

Select...

I cannot have an MRI due to claustrophobia, metal in my body, or a pacemaker.

Select...

I have had knee surgery on the same side within the last 3 years, or knee replacement at any time.

Select...

I have had a knee injection in the last 3 months.

Select...

I have a condition like rheumatoid arthritis, gout, or lupus.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1 month, 3 month and 12 month follow up visits

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 1 month, 3 month and 12 month follow up visits

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 month, 3 month and 12 month follow up visits for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Knee pain using Western Ontario and McMaster Universities Osteoarthritis index (WOMAC) score

Secondary study objectives

Change in Knee Stiffness

Change in Knee pain using the Visual Analogue Scale (VAS) scale

Change in Physical Functioning

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Embolization GroupExperimental Treatment2 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transcatheter arterial embolization

2005

N/A

~230

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for osteoarthritis (OA) work by targeting inflammation and pain. Nonsteroidal anti-inflammatory drugs (NSAIDs) inhibit cyclooxygenase enzymes to reduce inflammatory mediators, thereby alleviating pain and swelling. Corticosteroid injections suppress multiple inflammatory pathways for short-term pain relief. Geniculate artery embolization, an investigational approach, reduces blood flow to inflamed knee areas, potentially decreasing pain and inflammation. Understanding these mechanisms helps OA patients and their doctors choose the most suitable treatment based on individual needs and responses.