Genicular Artery Embolization Vs Observation for Symptomatic Knee Osteoarthritis (NCT04682652) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Genicular Artery Embolization Vs Observation for Symptomatic Knee Osteoarthritis
United States100 participantsStarted 2023-08-01
Plain-language 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 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 During the trial, all subjects will also get MRIs and fluid withdrawn from their knee joints at various timepoints in order to precisely figure out how the procedure works on a closer (microscopic) level.
Who can participate
Age range
40 Years – 79 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.