Geniculate Artery Embolization for Osteoarthritis

Overseen By Research Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Must be taking: Anti-inflammatories

Must not be taking: Anticoagulants

Disqualifiers: Smoking, Diabetes, Chronic pain, 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: 4

Duration: 12 months

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for people with mild to moderate knee osteoarthritis (OA). It examines how well geniculate artery embolization (a method to block certain blood vessels) manages symptoms compared to usual care, such as physical therapy and anti-inflammatory drugs. Participants will receive either this procedure along with standard care or just the standard care alone. Suitable candidates for this trial have experienced knee pain that hasn't improved with usual treatments like physical therapy or anti-inflammatory medications for at least three months. As an unphased trial, this study offers a unique opportunity to explore innovative treatment options that might provide relief when standard treatments have not worked.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on anticoagulation medications, they must be safely held for the procedure and for 7 days afterward.

What prior data suggests that geniculate artery embolization is safe for osteoarthritis?

Research has shown that geniculate artery embolization (GAE) generally provides a safe treatment for knee osteoarthritis. Studies have found that patients typically tolerate GAE well, experiencing noticeable improvements in pain and movement. One study noted significant improvements in knee symptoms, while another review found that GAE remained safe over a two-year period.

Although stronger evidence is needed, current data suggest that GAE offers a promising option for knee osteoarthritis with few side effects. This makes it a potential choice for those seeking non-surgical treatment options. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about geniculate artery embolization (GAE) for osteoarthritis because it offers a minimally invasive approach to managing knee pain, which is a significant advantage over traditional treatments like pain medications, physical therapy, or surgery. Unlike these standard options, GAE works by reducing blood flow to the inflamed areas of the knee, potentially leading to decreased pain and inflammation. This targeted approach could provide faster and more sustained relief, with fewer side effects compared to systemic medications or invasive surgical procedures.

What evidence suggests that geniculate artery embolization might be an effective treatment for osteoarthritis?

This trial will compare geniculate artery embolization (GAE) combined with standard care to standard care alone for knee osteoarthritis (OA). Studies have shown that GAE can greatly improve symptoms in people with knee OA. Research indicates that GAE is both safe and effective in reducing knee pain and improving joint function. In some studies, patients experienced noticeable relief that met established minimum improvement levels. Early results suggest that this treatment could be a promising alternative to more invasive procedures like surgery. Although more research is needed, initial findings are encouraging for those seeking non-surgical ways to manage knee OA. ^{1 2 3 4 6}

Who Is on the Research Team?

Reza Talaie, MD

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for people with mild to moderate knee osteoarthritis who haven't improved after at least 3 months of treatments like anti-inflammatory drugs or physical therapy. They should be under 250 pounds, not planning on knee replacement surgery soon, and able to get an MRI before and after the procedure. People can't join if they're over 250 pounds, have certain heart or blood conditions, severe allergies to iodine, are pregnant, or have had certain knee surgeries.

Inclusion Criteria

Patients who have been evaluated by an orthopaedic surgeon or sports medicine provider and deemed to not be a current candidate for partial or total knee arthroplasty. These patients do, however, need to be considered a potential candidate for partial or total knee as an end point following the natural history of osteoarthritis.

Patients with WOMAC Score >=6 in at least 2 categories

Patients who are symptomatically refractory of at least 3 months of medical and/or rehabilitation measures (anti-inflammatory drugs, and/or physical therapy, and/or strength conditioning, and/or 0-1 intra-articular injections of the affected knee)

Exclusion Criteria

Patients with a platelet count <50x109/L

Patients with a weight >250 pounds

Patients with advanced peripheral arterial disease (resting ABI <= 0.9)

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 and standard of care or standard of care only

12 months

4 visits (in-person) for GAE group, 2 visits (in-person) for SOC group

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Geniculate Artery Embolization

Trial Overview

The study tests geniculate artery embolization (a minimally invasive procedure that blocks abnormal blood vessels) plus standard care against standard care alone in managing knee osteoarthritis symptoms. It aims to see if this treatment can control symptoms better and slow down disease progression.

How Is the Trial Designed?

Group I: GAE + Standard of Care Experimental Treatment 1 Intervention

Participants in this arm will receive geniculate artery embolization and standard of care.

Group II: Standard of Care Active Control 1 Intervention

Participants in this arm will receive standard of care only.

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?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Published Research Related to This Trial

Geniculate Artery Embolization (GAE) is a safe and effective minimally-invasive treatment for mild to moderate knee osteoarthritis, showing significant improvements in pain and function over a period of up to 24 months, based on a review of 13 studies involving 399 knees.

Patients experienced notable reductions in pain and improved function as measured by the WOMAC and VAS scores, with statistically significant changes observed at multiple time points (1, 3, 6, 12, and 24 months) after the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The short-to-midterm outcomes of geniculate artery embolization for mild-to-moderate osteoarthritis of the knee: a systematic review. Bhatia, A., Bhatia, S.[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 has been shown to be a potentially effective treatment for chronic pain in patients with knee osteoarthritis, based on a review of 13 studies involving 914 patients.

The procedure is associated with only minor complications, suggesting it is a safe alternative for patients who do not respond to conventional treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Embolization of genicular arteries in patients with knee osteoarthritis as an alternative for refractory pain treatment: A systematic review]. Guevara-Noriega, KA., Chavez-Abiega, R., Castro-Rios, JG.[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]

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 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) 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.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9971280/

Genicular artery embolization for treatment of knee ...

Limited evidence suggests that GAE is a safe procedure that confers improvement in knee OA symptoms at established MCID thresholds.

2.

aaos.org

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

Data review presents geniculate artery embolization as an ...

Genicular artery embolization for treatment of symptomatic knee osteoarthritis: 2-year outcomes from a prospective IDE trial. J Vasc Interv ...

3.

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.

4.

pubs.rsna.org

pubs.rsna.org/doi/full/10.1148/rg.210159

Geniculate Artery Embolization: Role in Knee Hemarthrosis ...

Preliminary trials over the past decade have demonstrated promising clinical results, including decreased pain and improved function and quality ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04472091

Genicular Artery Embolization (GAE) for Osteoarthritic ...

The objective of this investigation is to evaluate the safety of the geniculate artery embolization (GAE) procedure with HydroPearl® Microspheres in 30 ...

6.

evtoday.com

evtoday.com/articles/2024-feb/genicular-artery-embolization-building-evidence-and-practice

Genicular Artery Embolization: Building Evidence and ...

The 1-year cumulative clinical success rate appears to be ≥ 60%, as measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) ...