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

NCT06134817 | Terminated Results FDA Device

• 1 other identifier: 23-00595
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Score From Baseline to Month 6

  The Pain subscale of the KOOS consists of 9 items measuring pain associated with the knee. Each item is rated on a Likert scale from 0 (No Problems) to 4 (Extreme Problems). The raw score is the sum of responses and is transformed to a 0-100 scale, where zero represents extreme knee problems and 100 represents no knee problems.

  Baseline, Month 6 Post-GAE Procedure

Secondary Outcomes (16)

• Change From Baseline in KOOS Symptoms Score

  Baseline, Month 3 Post-GAE Procedure

• Change From Baseline in KOOS Symptoms Score

  Baseline, Month 6 Post-GAE Procedure

• Change From Baseline in KOOS Symptoms Score

  Baseline, Month 12 Post-GAE Procedure

• Change From Baseline in KOOS Symptoms Score

  Baseline, Month 24 Post-GAE Procedure

• Change From Baseline in Knee Pain Measured Via Visual Analogue Scale (VAS)

  Baseline, Month 3 Post-GAE Procedure

Study Arms (1)

Patients with Post TKA Knee Pain

EXPERIMENTAL

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.

Device: Embozene Color-Advanced Microspheres.

Interventions

Embozene Color-Advanced Microspheres. 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.

Patients with Post TKA Knee Pain

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

Results Point of Contact

• Title: Bedros Taslakian, MD
• Organization: NYU Langone Health

Bedros.Taslakian@nyulangone.org

332-237-9866

Study Officials

• Bedros Taslakian, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: November 18, 2023
• Study Start: May 24, 2024
• Primary Completion: February 12, 2025
• Study Completion: February 12, 2025
• Last Updated: August 7, 2025
• Results First Posted: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Bedros.Taslakian@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)