NCT05349682

Bayer OA Knee Pain Pilot

Transcatheter Geniculate Arterial Embolization: Treatment and Monitoring of Response

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 25 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to investigate if MRI can be used to evaluated effect of knee artery embolization for knee osteoarthritis. Participants be evaluated in clinic, obtain a knee MRI, undergo embolization of the symptomatic knee, and follow up in clinic at 1, 6, and 12 months after embolization. A second MRI is obtained 6 months after embolization. Participants will keep a record of their pain level and treatment and answer questionnaires at each visit. In addition, this study aims to determine the effects of knee artery embolization on the amount of opioid (pain reliever drugs) needed to manage osteoarthritis-associated pain and change in quality of life.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	dynamic contrast enhanced MRI	An MRI study of the knee will be done to check the degree of osteoarthritis and blood flow to the affected knee. This scan will take about 1-2 hour(s).
PROCEDURE	geniculate artery embolization	The physician will perform a diagnostic angiography, where they will take pictures of vessels near the knee that will be treated. Once the artery to be treated is identified, the doctor will guide a thin wire called a microwire, and a plastic tube called a microcatheter to the targeted artery, and more pictures of vessels at the knee will be taken. This picture will be used to see if there are any abnormal vessels at the knee, such as abnormal blood flow, abnormal vessel connections (between the veins and arteries), or new blood vessel growth. Once the targeted artery at the knee is confirmed, the doctor will inject enough particle embolic (Embozene) to slow or stop the blood flow in the geniculate artery. Once all vessels are treated, a final angiogram (pictures of blood vessels) will be performed to ensure that the blood flow has slowed.

Timeline

• Start date: 2022-10-01
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2022-04-27
• Last updated: 2026-04-02

Locations

1 site across 1 country: United States