Knee Pain – GAE Procedure
Do you have moderate to severe knee pain from osteoarthritis? Do you have pain lasting at least 3 months even with other non-surgical therapies?
The University of North Carolina Department of Radiology, Vascular & Interventional Radiology Division is seeking adults that are 40 years of age and older with arthritis of the knee to participate in a clinical trial evaluating a new treatment for knee pain. The investigational treatment, which involves reducing the blood supply to inflammatory parts of the knee, could possibly eliminate the need for pain medication or injections.
Patients will be randomized into one of two study arms. Patients will have a 1-in-3 chance of being randomized into an arm where they will not receive the interventional treatment, but will receive a sham procedure that will not include the research embolization. You will not know which group you are in. If after 1 month you are enrolled in the sham arm and you have not seen relief from your symptoms, you will move into a new arm of the study and be eligible to receive the study treatment.
The primary aims of this study are to determine if geniculate artery embolization (GAE) will reduce pain and disability (resulting from pain, stiffness and difficulty performing daily activities) caused by knee osteoarthritis (OA). Embolization is a procedure where physicians intentionally block the blood vessels to specific areas of the body to prevent blood flow to that region. By doing this, the decrease in blood flow will decrease the size of the area of interest. In this case, your physician will block the geniculate artery, which is located in the knee, with the goal of decreasing the swelling around the knee, resulting in improvement of pain, stiffness, and difficulty performing daily activities from OA. Although embolization is used commonly throughout the body to treat bleeding and tumors, this technique has not yet been proven to improve OA in the knee, making this study experimental.
You should not be in this study if you have any of the following.
- Current local infection
- Life expectancy less than 6 months
- Known advanced atherosclerosis (plaque that builds within the vessels that lead blood to the heart)
- Rheumatoid or infectious arthritis
- Prior knee surgery
- Iodine allergy
- Kidney disease
- Inability to tolerate or undergo MRI
To inquire about the enrollment qualifications, please contact Terry Hartman at 919-966-4997 or email@example.com.