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

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.

Study Overview

• Status: Terminated
• Conditions: Knee Pain
• Intervention / Treatment: Device: Embozene Color-Advanced Microspheres.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Synovitis	Incidence of synovitis measured using magnetic resonance angiogram images.	Month 6 Post-GAE Procedure
Incidence of Synovitis	Incidence of synovitis measured using magnetic resonance angiogram images.	Month 24 Post-GAE Procedure
Incidence of Successful Selective Catheterization of Target Genicular Artery		Up to Month 24 Post-GAE Procedure
Change From Baseline in KOOS Symptoms Score	The Symptoms subscale of the KOOS consists of 7 items measuring symptoms 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 3 Post-GAE Procedure
Change From Baseline in KOOS Symptoms Score	The Symptoms subscale of the KOOS consists of 7 items measuring symptoms 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
Change From Baseline in KOOS Symptoms Score	The Symptoms subscale of the KOOS consists of 7 items measuring symptoms 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 12 Post-GAE Procedure
Change From Baseline in KOOS Symptoms Score	The Symptoms subscale of the KOOS consists of 7 items measuring symptoms 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 24 Post-GAE Procedure
Change From Baseline in Knee Pain Measured Via Visual Analogue Scale (VAS)	The VAS measures knee pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). The patient uses a ruler to measure the distance in centimeters from the 'no pain marker' (or zero) to the current pain mark. This provides a pain intensity score out of 10; for example, 6 out of 10 (or 6/10). Higher scores indicate greater knee pain.	Baseline, Month 3 Post-GAE Procedure
Change From Baseline in Knee Pain Measured Via VAS	The VAS measures knee pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). The patient uses a ruler to measure the distance in centimeters from the 'no pain marker' (or zero) to the current pain mark. This provides a pain intensity score out of 10; for example, 6 out of 10 (or 6/10). Higher scores indicate greater knee pain.	Baseline, Month 6 Post-GAE Procedure
Change From Baseline in Knee Pain Measured Via VAS	The VAS measures knee pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). The patient uses a ruler to measure the distance in centimeters from the 'no pain marker' (or zero) to the current pain mark. This provides a pain intensity score out of 10; for example, 6 out of 10 (or 6/10). Higher scores indicate greater knee pain.	Baseline, Month 12 Post-GAE Procedure
Change From Baseline in Knee Pain Measured Via VAS	The VAS measures knee pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). The patient uses a ruler to measure the distance in centimeters from the 'no pain marker' (or zero) to the current pain mark. This provides a pain intensity score out of 10; for example, 6 out of 10 (or 6/10). Higher scores indicate greater knee pain.	Baseline, Month 24 Post-GAE Procedure
Change From Baseline in Quality of Life Measured Via EuroQol-5 Dimension-5 Level (EQ-5D-5L) Score	Patient Reported Outcome (PRO) instrument that uses 6 questions to generally assess patients' quality of life. The EQ-5D-5L system defines so-called EQ5D Health States; depending on the level, a number is assigned to each dimension, so that a 5-digit number combination is obtained. This 5-digit number is converted into a score using an algorithm. This point value is called the EQ-5D-5L index. An index value of 1 represents the best possible quality of life, while an index value of <0 represents the worst possible quality of life.	Baseline, Month 3 Post-GAE Procedure
Change From Baseline in Quality of Life Measured Via EQ-5D-5L Score	Patient Reported Outcome (PRO) instrument that uses 6 questions to generally assess patients' quality of life. The EQ-5D-5L system defines so-called EQ5D Health States; depending on the level, a number is assigned to each dimension, so that a 5-digit number combination is obtained. This 5-digit number is converted into a score using an algorithm. This point value is called the EQ-5D-5L index. An index value of 1 represents the best possible quality of life, while an index value of <0 represents the worst possible quality of life.	Baseline, Month 6 Post-GAE Procedure
Change From Baseline in Quality of Life Measured Via EQ-5D-5L Score	Patient Reported Outcome (PRO) instrument that uses 6 questions to generally assess patients' quality of life. The EQ-5D-5L system defines so-called EQ5D Health States; depending on the level, a number is assigned to each dimension, so that a 5-digit number combination is obtained. This 5-digit number is converted into a score using an algorithm. This point value is called the EQ-5D-5L index. An index value of 1 represents the best possible quality of life, while an index value of <0 represents the worst possible quality of life.	Baseline, Month 12 Post-GAE Procedure
Change From Baseline in Quality of Life Measured Via EQ-5D-5L Score	Patient Reported Outcome (PRO) instrument that uses 6 questions to generally assess patients' quality of life. The EQ-5D-5L system defines so-called EQ5D Health States; depending on the level, a number is assigned to each dimension, so that a 5-digit number combination is obtained. This 5-digit number is converted into a score using an algorithm. This point value is called the EQ-5D-5L index. An index value of 1 represents the best possible quality of life, while an index value of <0 represents the worst possible quality of life.	Baseline, Month 24 Post-GAE Procedure
Incidence of Successful Embolization From at Least One Feeding Artery of the Knee Joint	Successful embolization defined as suppression or reduction in the filling of (blood flow in) abnormal vessels visible on angiography.	Up to Month 24 Post-GAE Procedure

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Bedros Taslakian, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2024
• Primary Completion (Actual): February 12, 2025
• Study Completion (Actual): February 12, 2025

Study Registration Dates

• First Submitted: November 13, 2023
• First Submitted That Met QC Criteria: November 13, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Actual): August 7, 2025
• Last Update Submitted That Met QC Criteria: August 6, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 23-00595

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Bedros.Taslakian@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes