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

Not Applicable

Recruiting

• Conditions: Knee Pain
• Interventions: Device: Embozene Color-Advanced Microspheres.

• Registration Number: NCT06134817
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-13
• Study First Submitted QC: 2023-11-13
• Study First Posted: 2023-11-18
• Study Start: 2024-05-24
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-20
• Last Update Posted: 2024-06-24
• Primary Completion: 2026-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with Post TKA Knee Pain	Embozene Color-Advanced Microspheres.	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.

Primary Outcome Measures

Name	Time	Method
Change in Knee injury and Osteoarthritis Outcome Score (KOOS) Pain Score from Baseline to Month 6	Baseline, Month 6 Post-GAE Procedure	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.

Secondary Outcome Measures

Name	Time	Method
Incidence of Successful Embolization from at least One Feeding Artery of the Knee Joint	Up to Month 24 Post-GAE Procedure	Successful embolization defined as suppression or reduction in the filling of (blood flow in) abnormal vessels visible on angiography.
Quality of Life Measured via EuroQol-5 Dimension-5 Level (EQ-5D-5L) Score	Month 24 Post-GAE Procedure	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.
KOOS Symptoms Score	Month 24 Post-GAE Procedure	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.
Knee Pain Measured via Visual Analogue Scale (VAS)	Month 3 Post-GAE Procedure	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.
Incidence of Synovitis	Month 24 Post-GAE Procedure	Incidence of synovitis measured using magnetic resonance angiogram images.
Incidence of Successful Selective Catheterization of Target Genicular Artery	Up to Month 24 Post-GAE Procedure
Knee Pain Measured via VAS	Month 24 Post-GAE Procedure	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.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States