Artery Embolization for Knee Osteoarthritis

(GRAVITY Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Siddharth A Padia, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of California, Los Angeles

Disqualifiers: Fibromyalgia, Autoimmune, Inflammatory disorder, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

The purpose of this clinical trial is to determine whether genicular artery embolization (GAE) is an effective way to treat knee pain from osteoarthritis. Pain from arthritis is often due to underlying inflammation in the joint. The inflammation is associated with increased abnormal blood flow going to the specific area of pain. If the investigator can reduce the blood flow, the inflammation can be reduced and the pain can be controlled. The GAE procedure is an experimental procedure to decrease the blood flow (embolize) to the specific region of the knee that is causing the pain. This will be done by infusing microscopic spheres into the specific blood vessel (genicular artery) supplying the area of pain in the knee. This is done through a procedure which is called an angiogram, which is done entirely through a pinhole at the creased of the thigh, using twilight (conscious) sedation. The investigators have already completed an initial trial at UCLA, and shown that this procedure is safe and effective. The purpose of this new trial is to compare outcomes of people undergoing the GAE procedure to those who do not undergo the procedure. A total of 100 patients will be enrolled, and 2/3 of the patients will be randomly selected to undergo the GAE procedure. 1/3 will not undergo the procedure. This is known as a randomized trial. During the trial, all subjects will also get MRIs and fluid withdrawn from their knee joints at various timepoints in order to precisely figure out how the procedure works on a closer (microscopic) level.

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 data supports the effectiveness of the treatment Genicular Artery Embolization for knee osteoarthritis?

Research shows that Genicular Artery Embolization (GAE) is a promising treatment for knee osteoarthritis, as it helps reduce pain by decreasing blood flow to inflamed areas in the knee. Studies, including systematic reviews and meta-analyses, suggest that GAE can be effective for patients whose knee pain does not improve with other treatments. ^{1 2 3 4 5}

Is genicular artery embolization (GAE) safe for treating knee osteoarthritis?

Genicular artery embolization (GAE) is generally considered safe for treating knee osteoarthritis, with studies showing a low incidence of adverse reactions. Some patients may experience minor issues like skin bruising or temporary knee stiffness, but major complications are uncommon. ^{1 4 6 7 8}

How is genicular artery embolization different from other treatments for knee osteoarthritis?

Genicular artery embolization (GAE) is a unique, minimally invasive treatment for knee osteoarthritis that targets the blood vessels (genicular arteries) supplying the knee to reduce pain, unlike traditional treatments that often involve medication or surgery. ^{1 3 5 9 10}

Research Team

Siddharth A Padia, MD

Principal Investigator

University of California, Los Angeles

Eligibility Criteria

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

Trial Timeline

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

Treatment Details

Interventions

• Genicular Artery Embolization (Embolization Agent)

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.

Participant Groups

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.

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Dr. Thomas Rando

University of California, Los Angeles

Chief Medical Officer since 2023

MD from UCLA

Amir Naiberg

University of California, Los Angeles

Chief Executive Officer since 2024

JD from UCLA

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

Findings from Research

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]

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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Classification of Genicular Artery Anatomic Variants Using Intraoperative Cone-Beam Computed Tomography. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Genicular Artery Embolization for the Treatment of Symptomatic Knee Osteoarthritis. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Genicular Artery Embolization as a Treatment for Osteoarthritis Related Knee Pain: A Systematic Review and Meta-analysis. [2023]

4. United States 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. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Osteoarthritis-Related Knee Pain Treated With Genicular Artery Embolization: A Systematic Review and Meta-analysis. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Multicenter Randomized Sham Controlled Study of Genicular Artery Embolization for Knee Pain Secondary to Osteoarthritis. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Genicular Artery Embolization Technique. [2023]

8. China pubmed.ncbi.nlm.nih.gov

[Efficacy analysis of selective genicular artery embolization in the treatment of knee pain secondary to osteoarthritis]. [2022]

9. United States 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. [2021]

10. Spain pubmed.ncbi.nlm.nih.gov

[Embolization of genicular arteries in patients with knee osteoarthritis as an alternative for refractory pain treatment: A systematic review]. [2022]