NCT05248308

Genicular Artery Embolization (GAE) for the Treatment of Chronic Post Knee Arthroplasty Pain

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study seeks to evaluate the safety and efficacy of genicular artery embolization (GAE) as a treatment for patients with chronic pain following primary total knee arthroplasty (TKA) or revision TKA at 6 months as measured by the Knee Injury and Osteoarthritis Outcome Score (KOOS).

Detailed description

This is a single center, single arm, prospective pilot study evaluating the safety and efficacy of genicular artery embolization (GAE) for treatment of chronic pain following primary total knee arthroplasty (TKA) or revision TKA. Following screening, eligible participants will be offered enrollment. Patients who demonstrate baseline imaging findings of knee synovitis either on US, MRI, or both modalities will be offered GAE. Genicular artery embolization will be performed using a SeQure® microcatheter (Guerbet LLC, Villepinte, France) using Embozene microspheres (Varian Medical Systems, Palo Alto, CA).

Conditions

• Knee Pain Chronic
• Knee Swelling Pain
• Arterial Occlusion

Interventions

Type	Name	Description
DEVICE	Embozene Microspheres	Embozene Microspheres are manufactured by Varian Medical Systems (Palo Alto, CA). These microspheres are non-resorbable hydrogel microspheres coated with polyzene-F. Embozene microspheres are approved for use in treating arteriovenous malformations, hypervascular tumors such as uterine fibroids and hepatomas, and prostatic arteries in patients with benign prostatic hyperplasia. One of the causes of chronic pain in the setting of a knee arthroplasty may be increased blood flow to the specific area(s) of pain. The purpose of this procedure is to reduce blood flow (embolize) to specific parts of the knee which are contributing to your pain. This procedure is performed by infusing the Embozene particles into specific knee arteries (genicular arteries) in the region of knee pain.

Timeline

• Start date: 2022-07-01
• Primary completion: 2023-07-01
• Completion: 2023-09-01
• First posted: 2022-02-21
• Last updated: 2023-03-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study