Genicular Artery Embolization Vs Observation for Symptomatic Knee Osteoarthritis
Active, not recruitingNot applicableNCT04682652
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 120 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 During the trial, all subjects will also get MRIs and fluid withdrawn from their knee joints at various timepoints in order to precisely figure out how the procedure works on a closer (microscopic) level.
Study details
- Official title
- GRAVITY: Genicular Artery Embolization Versus Observation for the Treatment of Symptomatic Knee Osteoarthritis: a Randomized Controlled Trial
- Conditions
- Knee Osteoarthritis
- Degenerative Joint Disease of Knee
- Interventions
- Device: Embozene MicroSpheres
- Sponsor
- University of California, Los Angeles
- Collaborators
- Varian Medical Systems
- Start date
- 2023-08-01
- Primary completion
- 2026-10-01
- Sex
- All
- Age range
- from 40 Years to 79 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria Subjects must meet all of the following inclusion criteria in order to be eligible for this study: * Provided informed consent * Age ≥ 40 years and less than 80 years * Ineligibility for or refusal of surgical management * Moderate-severe knee pain as determined by visual analog scale \> 5 out of 10 * Osteoarthritis based on X-ray. Kellgren-Lawrence score \> 2 based on radiograph completed within 3 months of procedure date. * Resistant/failed conservative treatment (e.g. NSAIDS/physical therapy/steroid joint injection/ hyaluronic acid joint injection) for at least 3 months * Able to comply with all treatments and protocol follow-up visits Exclusion Criteria Subjects that meet any of the following exclusion criteria will not be eligible for this study: * Mild knee pain as determined by visual analog scale \< 5 out of 10 * OA on knee radiograph resulting in greater than 20 degree varus or valgus angulation * Moderate loss of kidney function, define as estimated glomerular filtration rate of less than 45 mL/min. * Significant arterial atherosclerosis that would limit selective angiography * History of fibromyalgia, autoimmune, or inflammatory disorder * History of any lumbar spine surgery, spine injections, or radicular pain in the extremity believed to originate from the spine * Allergy to iodinated contrast agents * Active Infection or malignancy * Recent (within 12 months) or active nicotine use * Prior total or partial knee replacement in the subject knee * Active pregnancy * Uncorrectable bleeding diasthesis * Other medical, social, or psychological/physical conditions that, in the opinion of the investigator, preclude the patient from participating in the study.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04682652