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Departure of PI.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bedros Taslakian, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
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.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
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.
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Note that while the Protocol Enrollment is N=2, N=1 participant was a screen failure and did not begin the study. Thus, the Number of Participants started is N=1.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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N= 1 participant was a screen failure; thus, baseline characteristics are presented for the N= 1 participant who entered the study and was treated.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | Percent change in KOOS Pain score | Baseline, Month 6 Post-GAE Procedure |
|
6 months.
The PI recorded all reportable events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. At each study visit, the investigator inquired about the occurrence of AE/SAEs since the last visit. Events were followed for outcome information until resolution or stabilization.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bedros Taslakian, MD | NYU Langone Health | 332-237-9866 | Bedros.Taslakian@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 20, 2023 | Jul 7, 2025 | Prot_SAP_000.pdf |
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| 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 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 |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | 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. | Posted | Number | Percentage change in KOOS Symptoms score | Baseline, Month 3 Post-GAE Procedure |
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| Secondary | 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. | Posted | Number | Percentage change in KOOS Symptoms score | Baseline, Month 6 Post-GAE Procedure |
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| Secondary | 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. | Patient did not complete necessary follow-up visit to collect measure data. | Posted | Baseline, Month 12 Post-GAE Procedure |
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| Secondary | 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. | Patient did not complete necessary follow-up visit to collect measure data. | Posted | Baseline, Month 24 Post-GAE Procedure |
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| Secondary | 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. | Posted | Number | Percentage change in VAS score | Baseline, Month 3 Post-GAE Procedure |
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| Secondary | 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. | Posted | Number | Percentage change in VAS score | Baseline, Month 6 Post-GAE Procedure |
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| Secondary | 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. | Patient did not complete necessary follow-up visit to collect measure data. | Posted | Baseline, Month 12 Post-GAE Procedure |
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| Secondary | 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. | Patient did not complete necessary follow-up visit to collect measure data. | Posted | Baseline, Month 24 Post-GAE Procedure |
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| Secondary | 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. | Outcome data not collected at Month 3 timepoint. | Posted | Baseline, Month 3 Post-GAE Procedure |
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| Secondary | 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. | Posted | Number | Percentage change in EQ-5D-5L score | Baseline, Month 6 Post-GAE Procedure |
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| Secondary | 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. | Patient did not complete necessary follow-up visit to collect measure data. | Posted | Baseline, Month 12 Post-GAE Procedure |
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| Secondary | 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. | Patient did not complete necessary follow-up visit to collect measure data. | Posted | Baseline, Month 24 Post-GAE Procedure |
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| Secondary | Incidence of Synovitis | Incidence of synovitis measured using magnetic resonance angiogram images. | Outcome not assessed. | Posted | Month 6 Post-GAE Procedure |
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| Secondary | Incidence of Synovitis | Incidence of synovitis measured using magnetic resonance angiogram images. | Patient did not complete necessary follow-up visit to collect measure data. | Posted | Month 24 Post-GAE Procedure |
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| Secondary | Incidence of Successful Selective Catheterization of Target Genicular Artery | Patient did not complete necessary follow-up visit to collect measure data. | Posted | Up to Month 24 Post-GAE Procedure |
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| Secondary | 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. | Patient did not complete necessary follow-up visit to collect measure data. | Posted | Up to Month 24 Post-GAE Procedure |
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