NCT04592562

Genicular Artery Embolization to Reduce Pain Associated With Unilateral Mild to Moderate Osteoarthritis

Genicular Artery Embolization to Reduce Pain Associated With Unilateral Mild to Moderate Osteoarthritis: A Pilot Study to Assess Feasibility

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to perform a feasibility study to show the effectiveness of the genicular artery embolization procedure in reducing bilateral or unilateral osteoarthritic knee pain at 12 months as measured by WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) score, Knee Injury and Osteoarthritis Outcome (KOOS) score, and Oswestry Disability Index.

Detailed description

This is a single-center, pilot study to assess the feasibility of a study show the effectiveness of the genicular artery embolization (GAE) in reducing arthritic pain and dysfunction associated with mild to moderate Bilateral or unilateral osteoarthritis of the knee. Patients with bilateral or unilateral Grade 1-3 Osteoarthritis as diagnosed on standing weight-bearing knee radiographs per the Kellen-Lawrence Grading scale, will be offered enrollment to the study. Following a screening questionnaire, these patients will then be enrolled in this study. Baseline MRI will be obtained prior to the GAE procedure. Follow up intervals will include 3, 6, 9, and 12 months with the primary objective measured by a clinician as the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) score, Knee Injury and Osteoarthritis Outcome (KOOS) score, and Oswestry Disability Index at the 12-month follow up visit. Patients will also undergo 1 year follow up MRI to be interpreted by a diagnostic radiologist with subspecialty training in musculoskeletal radiology. This radiologist will compare the treated knee to the baseline screening according to the WORMS classification (Whole Organ Magnetic Resonance Scoring) to assess for radiologic changes of osteoarthritis and any adverse effects.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
DEVICE	the Terumo Hydropearl® microspheres device	Genicular artery embolization (GAE) is a new, minimally invasive investigational not yet approved therapy. In previous studies, this procedure has provided pain relief in patients with mild to moderate OA in the short to midterm. We will be utilizing the Terumo Hydropearl® microspheres particle beads during the GAE procedures. The procedure will take place utilizing fluoroscopic and ultrasound guidance. Following catheterization of the femoral artery, angiography of the affected limb will be performed to define the genicular arterial anatomy. Genicular arteries demonstrating abnormal vascularity and corresponding to the site of the patient's pain will be catheterized and embolized using microspheres. Prior to and after embolization, parametric imaging will be performed utilizing proprietary software to quantify changes in blood flow to the target area The intended use of the Terumo Hydropearl® microspheres device is to embolize the geniculate artery branch.

Timeline

• Start date: 2021-09-22
• Primary completion: 2024-05-28
• Completion: 2024-05-28
• First posted: 2020-10-19
• Last updated: 2024-11-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study