Genicular Artery Embolization for Knee Osteoarthritis

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Andrew Picel

Disqualifiers: Rheumatoid arthritis, Atherosclerosis, 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: 6

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a procedure called genicular artery embolization (GAE) to determine if it can safely reduce knee pain caused by osteoarthritis. The procedure blocks abnormal blood vessels in the knee to potentially lessen pain. Individuals with moderate to severe knee pain for at least three months, despite trying treatments like anti-inflammatory medications or physical therapy, might be suitable candidates. Researchers will follow participants for up to 24 months to assess the treatment's effectiveness. As an unphased trial, this study provides a unique opportunity to explore a novel treatment option for knee pain relief.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, since the trial includes patients who have tried anti-inflammatory medications, it seems you may continue them.

What prior data suggests that the genicular artery embolization procedure is safe for knee osteoarthritis?

Research has shown that genicular artery embolization (GAE) is generally safe for treating knee osteoarthritis. One study found that GAE can relieve knee pain for up to 24 months and is usually well-tolerated, though some side effects may occur. Another study found that using tiny particles called microspheres in doses over 2 ml is safe. Most patients, about 78–92%, experienced significant pain relief within 12 months. These findings suggest that GAE is a promising option, but like any procedure, it may involve some risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Genicular Artery Embolization (GAE) is unique because it targets the blood vessels supplying the knee, reducing inflammation and pain by blocking specific arteries. This is a new approach compared to standard treatments like pain medications, physical therapy, or even surgery, which don't directly address the blood supply to the knee. Researchers are excited about GAE because it offers a minimally invasive option that could provide relief without the need for more aggressive procedures like knee replacement. Plus, the use of HydroPearl® Microspheres allows for precise targeting, potentially leading to fewer side effects and faster recovery.

What evidence suggests that the genicular artery embolization procedure is effective for knee osteoarthritis?

Research has shown that Genicular Artery Embolization (GAE), the treatment under study in this trial, can effectively reduce knee pain from osteoarthritis. Studies indicate that 78–92% of patients experience significant pain relief, with pain levels dropping by 50% or more within 12 months. Other findings reveal a 60-80% reduction in pain at both 6 and 24 months after the procedure. GAE has provided lasting relief for up to 24 months. The procedure is generally safe, with some studies reporting a 62% success rate. Overall, GAE appears promising for those suffering from moderate to severe knee osteoarthritis pain. ^{1 2 3 5 6}

Who Is on the Research Team?

Andrew Picel, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for adults over 40 with moderate to severe knee pain due to osteoarthritis, who haven't found relief from anti-inflammatory meds, physical therapy, or injections. They should have certain MRI features of active synovitis and not be candidates for surgery. People with life-threatening allergies to iodine, recent major knee surgeries (except minor arthroscopic), serious coagulation issues, kidney problems or other types of arthritis are excluded.

Inclusion Criteria

My pain hasn't improved after 3 months of treatments like anti-inflammatory meds, physical therapy, or injections.

Your MRI shows signs of active joint inflammation.

I cannot or will not undergo surgery for my condition.

Exclusion Criteria

I have rheumatoid or infectious arthritis.

You have a blood clotting problem that cannot be fixed.

You are expected to live for less than 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo the genicular artery embolization (GAE) procedure with HydroPearl® Microspheres

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

4 visits (in-person) at 1, 6, 12, and 24 months post GAE

What Are the Treatments Tested in This Trial?

Interventions

• Genicular Artery Embolization (GAE)

Trial Overview The trial tests the safety of genicular artery embolization (GAE) using HydroPearl® Microspheres in patients with osteoarthritic knee pain. GAE blocks abnormal blood vessels in the knee that contribute to arthritis pain. The study will follow participants for up to 24 months.

How Is the Trial Designed?

Group I: Genicular artery embolization Experimental Treatment 1 Intervention

Participants will undergo the genicular artery embolization (GAE) procedure for the treatment of moderate to severe knee osteoarthritis. A total of 30 patients will be enrolled in the single treatment arm of the study. The study will involve a screening period in which patient eligibility is determined. Once eligibility is confirmed, patients will undergo GAE with HydroPearl® Microspheres (polyethylene glycol microspheres, Terumo Medical, Somerset NJ). Following treatment, patients will undergo follow-up at 1, 6, 12, and 24 months post GAE.

Genicular Artery Embolization (GAE) is already approved in United States, European Union for the following indications:

Approved in United States as Genicular Artery Embolization for:

• Osteoarthritic knee pain

Approved in European Union as Genicular Artery Embolization for:

• Pain from osteoarthritis of the knee not responsive to conservative treatment

Who Is Running the Clinical Trial?

Andrew Picel

Lead Sponsor

Trials

2

Published Research Related to This Trial

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]

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 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]

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]

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) 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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39322180/

2-Year Outcomes from a Prospective IDE Trial Conclusions: GAE is effective in achieving sustained symptom relief related to moderate-to-severe knee OA for up to 24 months with an acceptable safety profile.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1076633225004398

Meta-Analysis of Genicular Artery Embolization in Knee ... About 78–92% of patients achieved clinically meaningful improvement (≥50% pain reduction or ≥10–15 point change) by 12 months. However, sham- ...

3. jvir.org jvir.org/article/S1051-0443(24)00581-5/fulltext

Genicular Artery Embolization for Treatment of ... GAE is effective in achieving sustained symptom relief related to moderate-to-severe knee OA for up to 24 months with an acceptable safety ...

4. aaos.org aaos.org/aaosnow/2025/aug-sept/clinical/clinical01/

Data review presents geniculate artery embolization as an ... Several uncontrolled prospective studies have shown 60-80% pain reduction on the visual analog scale at six and 24 months after GAE, suggesting ...

5. rheumatologyadvisor.com rheumatologyadvisor.com/news/genicular-artery-embolization-safe-relieves-pain-for-symptomatic-knee-oa/

Genicular Artery Embolization Safe, Relieves Pain for ... There was a 62 percent clinical success rate. The mean visual analog scale pain score for the target knee decreased by 48.5, 50.8, and 55.4 ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39971795/

Genicular Artery Embolization in Moderate to Severe Knee ... Conclusion: Embolization of multiple genicular artery branches in a single session using microspheres in averaged doses higher than 2 ml total is safe and ...