NCT06134817

Geniculate Artery Embolization for Treatment of Persistent Knee Pain Post Total Knee Arthroplasty

Prospective Pilot Study on Geniculate Artery Embolization for Treatment of Persistent Knee Pain Post Total Knee Arthroplasty

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 30 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Single-arm, single-center, no sham or placebo, prospective pilot trial designed to evaluate the safety and efficacy of transcatheter arterial embolization in patients with persistent knee pain resistant to conservative management for at least 9 months after total knee arthroplasty (TKA). Eligible participants will receive geniculate artery embolization (GAE) using Embozene™ Color-Advanced Microspheres. Patients will be followed up for a total of 24 months after GAE.

Conditions

• Knee Pain

Interventions

Type	Name	Description
DEVICE	Embozene Color-Advanced Microspheres.	Embozene Microspheres are spherical, tightly calibrated, biocompatible, nonresorbable, hydrogel microspheres coated with an inorganic perfluorinated polymer. The microspheres are intended to occlude vasculature for the purpose of blocking blood flow to a target tissue. In the study, the abnormal vessels will be embolized with 100 μm Embozene Microspheres solution under direct fluoroscopic visualization to prevent reflux and non-target embolization. Multiple geniculate arteries may be embolized until neovascularity is no longer seen.

Timeline

• Start date: 2024-05-24
• Primary completion: 2025-02-12
• Completion: 2025-02-12
• First posted: 2023-11-18
• Last updated: 2025-08-07
• Results posted: 2025-08-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study