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

Study Overview
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Brief Summary
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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.

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

Conditions
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Knee Pain

Intervention / Treatment
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* Device: Embozene Color-Advanced Microspheres.


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with Post TKA Knee Pain<br>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.<br>* 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.<br>|

What is the study measuring?
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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 |
| --- | --- | --- |
| 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. | Month 3 Post-GAE Procedure | 
| 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. | Month 6 Post-GAE Procedure | 
| 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. | Month 12 Post-GAE Procedure | 
| 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. | Month 24 Post-GAE Procedure | 
| 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. | Month 3 Post-GAE Procedure | 
| 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. | Month 6 Post-GAE Procedure | 
| 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. | Month 12 Post-GAE Procedure | 
| 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. | Month 24 Post-GAE Procedure | 
| 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. | Month 3 Post-GAE Procedure | 
| 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. | Month 6 Post-GAE Procedure | 
| 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. | Month 12 Post-GAE Procedure | 
| 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. | Month 24 Post-GAE Procedure | 
| 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 | 
| 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 |