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Embolization Agent

Artery Embolization for Knee Osteoarthritis (GRAVITY Trial)

N/A

Recruiting

Led By Siddharth Padia, MD

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Moderate-severe knee pain as determined by visual analog scale > 5 out of 10

Ineligibility for or refusal of surgical management

Must not have

OA on knee radiograph resulting in greater than 20 degree varus or valgus angulation

Significant arterial atherosclerosis that would limit selective angiography

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6-24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a new procedure, genicular artery embolization, is an effective way to treat knee pain from osteoarthritis by reducing blood flow to the area of pain.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort at the injection site in the thigh crease due to angiogram pinhole entry, allergic reactions to materials used such as contrast agents or microspheres, temporary numbness or bruising around the treated area.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I cannot or do not want to undergo surgery for my condition.

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I am between 40 and 79 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have severe artery blockage that could affect heart imaging tests.

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I have had a knee replacement surgery on my affected knee.

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I do not have an active infection or another type of cancer.

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I have had surgery or injections in my lower back or have had leg pain originating from my spine.

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My kidney function is moderately reduced.

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I have a history of fibromyalgia, autoimmune, or inflammatory disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6-24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6-24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in clinical response

Secondary study objectives

Change in MRI

Change in inflammatory biomarkers

Change in quality of life

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: GAE TreatmentExperimental Treatment1 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: ObservationalActive Control1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Embozene MicroSpheres

2019

N/A

~40

0 / 10Eligibility criteria met