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

NCT ID: NCT06134817

Last Updated: 2025-08-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-24
• Study Completion Date: 2025-02-12

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients with Post TKA Knee Pain

Patients with persistent knee pain resistant to conservative management for at least 9 months after total knee arthroplasty (TKA) will receive geniculate artery embolization (GAE) using Embozene Color-Advanced Microspheres. Treatment will be completed during one interventional session.

Group Type: EXPERIMENTAL

Embozene Color-Advanced Microspheres.

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Knee pain resistant to conservative treatment for at least 9 months post TKA performed for knee OA, and
• Moderate to severe knee pain: pain VAS ≥40 mm, and
• Willing, able, and mentally competent to provide informed consent and complete study questionnaires in English. The Study questionnaires are validated in English.

Exclusion Criteria

• Active systemic or local knee infection or;
• Active malignancy or;
• Life expectancy less than 6 months or;
• Prior ipsilateral knee arthroscopic surgery or repeat TKA (within 9 months of screening) or;
• Ipsilateral knee intra-articular injection in the last 3 months or;
• Rheumatoid arthritis, spondyloarthropathies, crystal disease, gout, pseudogout, or lupus or;
• Pregnant during the study period or;
• Renal dysfunction as defined by serum creatinine >1.6 dl/mg or eGFR <60 on blood tests obtained within 30 days of procedure or;
• Body weight greater than 200 Kg or;
• Known history of severe contrast allergy to iodinated contrast resulting in anaphylaxis or;
• Known significant arterial atherosclerosis that would limit selective angiography and/or lower extremity symptoms thought to be secondary to arterial vascular disease (eg claudication, ischemic rest pain) or;
• known avascular necrosis in the target knee or;
• Complications of TKA such as suspected or confirmed early loosening, ligamentous instability, reflex sympathetic dystrophy, polyethylene wear with or without particle disease (osteolysis), and large effusions (with or without hemarthrosis) or;
• Patient is enrolled in a different trial for treatment of knee pain post total knee arthroplasty (ipsilateral knee)

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bedros Taslakian, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

NYU Langone Health

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

23-00595

Identifier Type: -

Identifier Source: org_study_id