RecruitingNot ApplicableNCT04682652

Genicular Artery Embolization Vs Observation for Symptomatic Knee Osteoarthritis

GRAVITY: Genicular Artery Embolization Versus Observation for the Treatment of Symptomatic Knee Osteoarthritis: a Randomized Controlled Trial

Sponsor

University of California, Los Angeles

Enrollment

100 participants

Start Date

Aug 1, 2023

Study Type

INTERVENTIONAL

Conditions

Knee Osteoarthritis Degenerative Joint Disease of Knee

Summary

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 During the trial, all subjects will also get MRIs and fluid withdrawn from their knee joints at various timepoints in order to precisely figure out how the procedure works on a closer (microscopic) level.

Eligibility

Min Age: 40 YearsMax Age: 79 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing genicular artery embolization (GAE) — a minimally invasive procedure that reduces blood flow to the inflamed lining of the knee — against observation alone in patients with moderate-to-severe knee osteoarthritis who cannot or will not have surgery. GAE works by reducing the blood supply that drives painful inflammation in the knee joint. This trial aims to determine whether GAE provides meaningful and lasting pain relief. You may be eligible if: - You are between 40 and 79 years old - You are not eligible for surgery or have refused surgical treatment for your knee - You have moderate-to-severe knee pain (greater than 5/10 on a visual analog scale) - Your knee osteoarthritis is confirmed on X-ray (Kellgren-Lawrence score greater than 2) - You have failed at least 3 months of conservative treatments (NSAIDs, physical therapy, steroid or hyaluronic acid injections) You may NOT be eligible if: - Your knee pain is mild (less than 5/10) - You have severe knee deformity (greater than 20 degrees of varus/valgus angulation) - You have moderate-to-severe kidney disease (eGFR less than 45) - You have a history of fibromyalgia, autoimmune, or inflammatory joint disease - You have a history of lumbar spine surgery or nerve pain from the spine - You are allergic to iodinated contrast - You have active infection, active malignancy, or are currently pregnant - You are a current or recent (within 12 months) cigarette smoker - You have already had a partial or total knee replacement Talk to your interventional radiologist or orthopedic surgeon about whether this procedure is appropriate for your specific knee anatomy and medical history.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEEmbozene MicroSpheres

Embozene is a medical device made by Boston Scientific approved in the United States for the treatment of hypervascular tumors and arteriovenous malformations. It consists of thousands of microscopic spheres that are injected into the artery in the knee going to the region of pain. One of the causes of pain in the setting of knee arthritis is increased blood flow going to the specific area of pain. The goal of this procedure is to decrease the blood flow (embolize) to the specific region of the knee that is causing your pain. This is done by infusing Embozene particles into the specific blood vessel (genicular artery) supplying the area of pain in the knee.