Artery Embolization for Knee Pain

Overseen By Bedros Taslakian, MD

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)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new procedure called geniculate artery embolization (GAE) to determine if it can safely and effectively reduce knee pain that persists nine months after knee replacement surgery. The focus is on patients experiencing moderate to severe knee pain that does not respond to usual care. Ideal participants are those who have undergone knee replacement for arthritis and still experience significant knee pain. As an unphased trial, this study provides patients the opportunity to explore innovative solutions for persistent knee pain.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that geniculate artery embolization is safe for treating knee pain?

Research has shown that geniculate artery embolization (GAE) is a safe treatment option. Studies have found that GAE effectively reduces ongoing knee pain after total knee replacement surgery. This treatment works by blocking certain blood vessels in the knee to relieve pain.

The research indicates that patients generally tolerate GAE well. Reports have not shown significant adverse events, meaning serious side effects are rare. The treatment is minimally invasive, requiring no large cuts, which often leads to fewer complications. Overall, GAE appears to be a safe choice for those experiencing persistent knee pain after surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Geniculate Artery Embolization (GAE) is unique because it targets the blood vessels in the knee, specifically reducing inflammation and pain by blocking small arteries with tiny microspheres. This method is different from standard treatments like pain medications, physical therapy, and sometimes repeat surgeries, which aren't always effective for everyone. Researchers are excited about GAE because it offers a minimally invasive alternative that can potentially provide relief in just one session, which could be a game-changer for patients with persistent knee pain following total knee arthroplasty (TKA).

What evidence suggests that geniculate artery embolization is effective for knee pain?

Research has shown that geniculate artery embolization (GAE) is a promising method to reduce knee pain after total knee replacement surgery, especially when other treatments have failed. In this trial, participants with persistent knee pain after total knee arthroplasty (TKA) will receive GAE using Embozene Color-Advanced Microspheres. Studies indicate that GAE can be safe and effective, significantly improving pain and movement for many patients. One study found that 56% of patients experienced success after the first treatment, increasing to 85% with additional treatments. Another study suggested that GAE can reduce pain for up to 12 months. Overall, GAE appears to be a well-tolerated option for those dealing with ongoing knee pain after surgery. ^{1 2 5 6 7}

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 individuals who have had knee replacement surgery (TKA) but still experience moderate to severe pain that hasn't improved with standard treatments for at least 9 months. Participants must be able to understand and fill out study questionnaires in English.

Inclusion Criteria

My knee still hurts 9 months after surgery despite treatment.

I experience moderate to severe knee pain.

I can give informed consent and fill out questionnaires in English.

Exclusion Criteria

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

Life expectancy less than 6 months

Body weight greater than 200 Kg

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 (GAE) using Embozene™ Color-Advanced Microspheres in one interventional session

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Regular visits as per study protocol

What Are the Treatments Tested in This Trial?

Interventions

• Geniculate Artery Embolization

Trial Overview The trial is testing a procedure called geniculate artery embolization (GAE) using Embozene Color-Advanced Microspheres, which aims to reduce persistent knee pain after TKA. It's a single-arm study without a placebo group, tracking patient outcomes for up to 24 months post-procedure.

How Is the Trial Designed?

Group I: Patients with Post TKA Knee Pain Experimental Treatment 1 Intervention

Patients with persistent knee pain resistant to conservative management for at least 9 months after total knee arthroplasty (TKA) will receive geniculate artery embolization (GAE) using Embozene Color-Advanced Microspheres. Treatment will be completed during one interventional session.

Geniculate Artery Embolization is already approved in United States, European Union for the following indications:

Approved in United States as Genicular Artery Embolization for:

• Symptomatic management of knee osteoarthritis

Approved in European Union as Genicular Artery Embolization for:

• Treatment of chronic mild to moderate knee pain secondary to osteoarthritis

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Published Research Related to This Trial

Genicular artery embolization (GAE) is an effective minimally invasive treatment for knee pain due to osteoarthritis, showing significant reductions in pain scores at 1, 3, 6, and 12 months after the procedure, based on a systematic review of 10 studies involving 351 treated knees.

Patients experienced substantial declines in pain, with a Hedge's g effect size indicating strong pain relief, particularly at 6 months with a score decrease of 41 points on the Visual Analog Scale, demonstrating GAE's potential as a durable pain management option for osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genicular Artery Embolization as a Treatment for Osteoarthritis Related Knee Pain: A Systematic Review and Meta-analysis. Epelboym, Y., Mandell, JC., Collins, JE., et al.[2023]

In a study of 21 patients with mild to moderate knee osteoarthritis, genicular artery embolization (GAE) significantly reduced pain and disability compared to a sham procedure, with notable improvements observed at 1 month.

Only minor adverse events were reported, indicating that GAE is a safe intervention for treating knee pain associated with osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicenter Randomized Sham Controlled Study of Genicular Artery Embolization for Knee Pain Secondary to Osteoarthritis. Bagla, S., Piechowiak, R., Sajan, A., et al.[2022]

Genicular artery embolization (GAE) is a promising treatment for symptomatic knee osteoarthritis, showing a significant reduction in pain and symptoms over 12 months, with 68% of patients experiencing at least a 50% reduction in pain scores.

The procedure was found to be technically successful in all 40 participants, with a generally acceptable safety profile, although some patients experienced mild and transient side effects, such as skin discoloration and knee pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genicular Artery Embolization for the Treatment of Symptomatic Knee Osteoarthritis. Padia, SA., Genshaft, S., Blumstein, G., et al.[2022]

Genicular artery embolization (GAE) has been shown to significantly reduce knee pain in patients with osteoarthritis, with improvements in pain scores observed from 54% to 80% over a two-year follow-up based on the visual analog scale (VAS).

The procedure is generally safe, with no severe complications reported, and it also led to a notable decrease in the need for pain medications, including a 73% reduction in the use of intra-articular hyaluronic acid injections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Osteoarthritis-Related Knee Pain Treated With Genicular Artery Embolization: A Systematic Review and Meta-analysis. Torkian, P., Golzarian, J., Chalian, M., et al.[2022]

Genicular artery embolisation (GAE) is a promising treatment for knee osteoarthritis, and understanding the anatomy of the genicular arteries is crucial for ensuring the safety and effectiveness of the procedure, as demonstrated by a detailed dissection of 20 human lower limb specimens.

The study found that the descending genicular artery (DGA) is the primary vessel involved in medial osteoarthritis, with significant risks of non-target embolisation (NTE) due to anastomoses between key arteries, highlighting the need for careful planning during GAE to avoid damaging critical structures like the cruciate ligaments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cadaveric and Angiographic Anatomical Considerations in the Genicular Arterial System: Implications for Genicular Artery Embolisation in Patients with Knee Osteoarthritis. O'Grady, A., Welsh, L., Gibson, M., et al.[2021]

A study of 205 patients who underwent genicular artery embolization (GAE) revealed that the anatomy of the genicular arteries is complex, with various branching patterns identified, which is crucial for effective treatment of knee osteoarthritis.

Using cone-beam computed tomography (CBCT) during the procedure allows for better visualization of these arteries, helping to accurately target the right vessels for embolization and reducing the risk of affecting unintended areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Classification of Genicular Artery Anatomic Variants Using Intraoperative Cone-Beam Computed Tomography. Callese, TE., Cusumano, L., Redwood, KD., et al.[2023]

Selective genicular artery embolization (GAE) showed a high clinical improvement rate of 95.6% at 1 month and maintained significant pain relief at 6 months for patients with knee pain due to osteoarthritis, based on assessments using the Visual Analogue Scale (VAS) and WOMAC scores.

The procedure had a low incidence of adverse reactions, with only minor issues reported, such as skin ecchymosis and temporary knee stiffness, indicating that GAE is a safe and effective treatment option for patients who do not respond to conservative therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Efficacy analysis of selective genicular artery embolization in the treatment of knee pain secondary to osteoarthritis]. Sun, CH., Gao, ZL., Lin, K., et al.[2022]

Genicular artery embolization (GAE) shows promise as a treatment for knee osteoarthritis, with pain being the most commonly reported outcome in 95.8% of the 24 studies reviewed.

However, the studies exhibit significant variability in design and methodology, which limits the ability to draw strong conclusions about the efficacy and safety of GAE, highlighting the need for more standardized research protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Common Design, Data Elements and Core Outcome Measures Reported on Clinical Trials of Genicular Artery Embolization for Knee Osteoarthritis: An Interactive Systematic Review. Bolsegui, ML., Ghozy, S., Kobeissi, H., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37391071/

Effectiveness of Geniculate Artery Embolization for Chronic ... GAE is a safe method of treating persistent pain after TKA that demonstrates potential efficacy at 12 months.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1051044323004864

Effectiveness of Geniculate Artery Embolization for Chronic ... GAE is a safe method of treating persistent pain after TKA that demonstrates potential efficacy at 12 months.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10764703/

Combined genicular artery embolization and genicular nerve ... This report aims to highlight the benefit of combining embolotherapy and neurolysis intervention for symptomatic relief of post-TKA pain in a ...

4. evtoday.com evtoday.com/articles/2025-feb/genicular-artery-embolization-a-practical-guide-for-interventional-radiologists

Genicular Artery Embolization: A Practical Guide for ... Data show that clinical success was achieved in 56%, 79%, and 85% of patients after the first, second, and third GAE, respectively.8 Although evidence supports ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0720048X24001591

Genicular artery embolization for the treatment of knee pain ... GAE is a well-tolerated and effective treatment that significantly improves pain symptoms and function in patients with mild-to-severe knee osteoarthritis.

6. cvirendovasc.springeropen.com cvirendovasc.springeropen.com/articles/10.1186/s42155-023-00409-3

Combined genicular artery embolization and ... The combination of genicular artery embolization and genicular nerve block may be a technically safe and effective option for alleviating chronic pain after ...

7. pubs.rsna.org pubs.rsna.org/doi/abs/10.1148/rg.210159

Geniculate Artery Embolization: Role in Knee ... Geniculate artery embolization (GAE) is a minimally invasive intra-arterial intervention that was originally developed for the treatment of knee hemarthrosis.