NCT06781463

Creation of a Prospective Data Collecting Registry for Genicular Artery Embolization for Arthritis

Creation of a Prospective Data Collecting Registry for Genicular Artery Embolization for Arthritis (GAE)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to create a prospective registry (\<100 patients) to show the effectiveness of the genicular artery embolization procedure overtime in reducing bilateral or unilateral osteoarthritic knee pain as measured by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score.

Detailed description

Knee osteoarthritis (KOA) is a pervasive and debilitating disease, affecting over 15 million people in the US alone. Symptoms include pain, stiffness, and ultimately loss of joint function. Medical therapies are the mainstay of treatment as surgical joint replacement is typically reserved for advanced disease. Only half of patients treated by medical management with disease not severe enough to warrant surgery experience adequate pain relief, resulting in an estimated population of 3.6 million Americans who are left suffering. Genicular artery embolization (GAE) is a novel, minimally invasive treatment that uses radiologic techniques to catheterize pathologically hyperemic genicular arteries using live X-ray guidance with subsequent occlusion of these vessels using injected microspheres. GAE is performed to inhibit or blunt synovial inflammation thought to be a primary phenotype of KOA. Multiple small sized cohort studies have shown to significantly reduce pain associated with KOA. This procedure has been performed in the University of Chicago Medical Center and showed its effectiveness and safety. In this study, the investigators plan to establish a prospective database of patients undergoing GAE for KOA in order to further characterize its effectiveness with a longer follow-up and larger sample size. The investigators also hope to establish Magnetic Resonance Imaging (MRI) as an objective imaging biomarker for positive remodeling of the knee that occurs after GAE due to decreased synovitis. If the results of this study are positive, the investigators plan to conduct a definitive sham-controlled study to justify the use of GAE in medically refractory KOA and help provide a treatment option to the millions of people with this disease.

Conditions

• Knee Osteoarthritis
• Knee Osteoarthritis (Knee OA)
• Knee Osteoarthritis (OA)

Interventions

Type	Name	Description
OTHER	Registry (N/A)	This study is a registry, thus no research intervention is being directly tested.

Timeline

• Start date: 2023-10-01
• Primary completion: 2028-10-01
• Completion: 2028-10-01
• First posted: 2025-01-17
• Last updated: 2025-01-20

Locations

1 site across 1 country: United States