Artery Embolization for Knee Osteoarthritis

(GRAVITY Trial)

Recruiting at 1 trial location

Overseen By Aniket Joglekar, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Disqualifiers: Fibromyalgia, Autoimmune, Inflammatory disorder, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 14

Duration: 6 months

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if genicular artery embolization (GAE) can ease knee pain from osteoarthritis by reducing blood flow to inflamed areas. Participants will be randomly divided into two groups: 2/3 will receive the GAE treatment, and 1/3 will not. The trial will observe differences in pain relief and joint changes between these groups. Ideal candidates are those over 40 with moderate to severe knee pain from osteoarthritis that hasn't improved with other treatments. As an unphased trial, this study offers a unique opportunity to explore a new treatment option for knee pain relief.

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, since the trial requires participants to have failed conservative treatments like NSAIDs or steroid injections, it might be possible to continue some medications. Please consult with the trial coordinators for specific guidance.

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

Research has shown that genicular artery embolization (GAE) is generally safe for treating knee osteoarthritis (OA). GAE is a minimally invasive procedure, not requiring major surgery, and most people tolerate it well. Studies have found that pain decreased by 60-80% after six to 24 months, indicating it helps relieve knee pain.

These studies also report that GAE can provide symptom relief for up to two years. While some risks exist, they are considered acceptable. The procedure involves injecting tiny particles into the knee's blood vessels to reduce the blood flow that causes pain. Overall, evidence supports GAE as a safe option for knee OA, but it is important to note that the research has involved small groups of participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about genicular artery embolization (GAE) for knee osteoarthritis because it offers a new way to manage pain by specifically targeting the arteries supplying the knee. Unlike standard treatments like pain medications, physical therapy, or even surgery, GAE uses Embozene Microspheres to reduce blood flow to inflamed areas, potentially decreasing pain and inflammation directly at the source. This minimally invasive procedure could provide a quicker recovery time and may offer a long-lasting solution compared to conventional methods, making it a promising option for those seeking alternatives to traditional knee osteoarthritis treatments.

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

Research has shown that genicular artery embolization (GAE), which participants in this trial may receive, can effectively reduce knee pain in people with osteoarthritis. Studies have found that about 78–92% of patients experience significant pain relief, with at least a 50% reduction in pain, within a year. GAE has provided lasting symptom relief for up to two years. This procedure reduces blood flow to the inflamed part of the knee, decreasing inflammation and pain. Most studies suggest that it is generally safe for patients. ^{1 3 4 5 6}

Who Is on the Research Team?

Siddharth A Padia, MD

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

This trial is for adults aged 40-79 with moderate to severe knee pain from osteoarthritis, who haven't had success with standard treatments like NSAIDs or joint injections. Participants should have a Kellgren-Lawrence score >2 and be ineligible for or refuse surgery. Exclusions include certain medical conditions, allergies, pregnancy, recent smoking history, and previous knee replacements.

Inclusion Criteria

My condition did not improve after 3 months of standard treatments like painkillers, physical therapy, or joint injections.

My X-ray shows I have moderate to severe osteoarthritis.

My knee pain is more than 5 out of 10 on a pain scale.

Exclusion Criteria

You have smoked cigarettes in the past year or currently smoke.

My knee X-ray shows severe OA with significant bending.

Allergy to iodinated contrast agents

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo genicular artery embolization (GAE) or are observed without intervention. GAE involves infusing microspheres into the genicular artery to reduce blood flow and inflammation.

6 months

Initial procedure followed by visits at 1, 3, and 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, with evaluations including MRI, serum and joint aspiration, and clinical assessments.

24 months

Follow-up visits at 12 and 24 months

Crossover

Participants in the observation group have the option to crossover to the GAE treatment arm after 6 months, with follow-up evaluations similar to initial GAE subjects.

18 months

Follow-up visits at 1, 3, 6, 12, and 24 months post-crossover

What Are the Treatments Tested in This Trial?

Interventions

• Genicular Artery Embolization

Trial Overview The study tests if genicular artery embolization (GAE), which reduces blood flow to the painful area of the knee using Embozene MicroSpheres during an angiogram procedure, can alleviate arthritis pain compared to no intervention. It's a randomized trial where two-thirds of participants will undergo GAE and one-third will not.

How Is the Trial Designed?

Group I: GAE Treatment Experimental Treatment 1 Intervention

Subjects will be treated with a genicular artery embolization (GAE) procedure performed with Embozene Microspheres. The microspheres will be delivered in a saline-contrast medium solution and will be delivered to the arteries supplying the areas of the subject's pain.

Group II: Observational Active Control 1 Intervention

Subjects randomized to the observational group will not undergo the experimental GAE Treatment. PI will offer subjects enrolled into the observational group to crossover to the experimental GAE Treatment group after they have completed their 6-month follow-up assessments.

Genicular Artery Embolization is already approved in United States for the following indications:

Approved in United States as Genicular Artery Embolization for:

• Symptomatic knee osteoarthritis

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Varian Medical Systems

Industry Sponsor

Trials

63

Recruited

3,700+

Dow R. Wilson

Varian Medical Systems

Chief Executive Officer since 2012

MBA from Dartmouth's Amos Tuck School of Business, BA from Brigham Young University

Dr. Deepak Khuntia

Varian Medical Systems

Chief Medical Officer since 2020

MD from the University of Cambridge, PhD from the University of Leicester

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 safe and effective treatment for knee pain caused by osteoarthritis, offering long-lasting pain relief for many patients.

Successful GAE requires careful attention to procedural techniques, including understanding arterial anatomy and avoiding complications, but when performed correctly, adverse events are rare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genicular Artery Embolization Technique. Sterbis, E., Casadaban, L.[2023]

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 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 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]

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]

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. 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. sciencedirect.com sciencedirect.com/science/article/pii/S0972978X25002880

Genicular artery embolization for knee osteoarthritis GAE appears to be a safe and minimally invasive treatment that may provide short-term symptomatic relief in select KOA patients. However, limited sample sizes, ...