Trial Outcomes & Findings for Geniculate Artery Embolization for Treatment of Persistent Knee Pain Post Total Knee Arthroplasty (NCT NCT06134817)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

2 participants

Primary outcome timeframe

Baseline, Month 6 Post-GAE Procedure

Results posted on

2025-08-07

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Physician Departure - termination of study	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients With Post TKA Knee Pain n=1 Participants 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.
Age, Continuous	74 years STANDARD_DEVIATION NA • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Patients With Post TKA Knee Pain n=1 Participants 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.
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Score From Baseline to Month 6	20 Percent change in KOOS Pain score

SECONDARY outcome

Timeframe: Baseline, Month 3 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.

Outcome measures

Outcome measures
Measure	Patients With Post TKA Knee Pain n=1 Participants 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.
Change From Baseline in KOOS Symptoms Score	23 Percentage change in KOOS Symptoms score

SECONDARY outcome

Timeframe: Baseline, Month 6 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.

Outcome measures

Outcome measures
Measure	Patients With Post TKA Knee Pain n=1 Participants 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.
Change From Baseline in KOOS Symptoms Score	31 Percentage change in KOOS Symptoms score

SECONDARY outcome

Timeframe: Baseline, Month 12 Post-GAE Procedure

Population: Patient did not complete necessary follow-up visit to collect measure data.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Month 24 Post-GAE Procedure

Population: Patient did not complete necessary follow-up visit to collect measure data.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 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.

Outcome measures

Outcome measures
Measure	Patients With Post TKA Knee Pain n=1 Participants 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.
Change From Baseline in Knee Pain Measured Via Visual Analogue Scale (VAS)	42 Percentage change in VAS score

SECONDARY outcome

Timeframe: Baseline, Month 6 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.

Outcome measures

Outcome measures
Measure	Patients With Post TKA Knee Pain n=1 Participants 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.
Change From Baseline in Knee Pain Measured Via VAS	46 Percentage change in VAS score

SECONDARY outcome

Timeframe: Baseline, Month 12 Post-GAE Procedure

Population: Patient did not complete necessary follow-up visit to collect measure data.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Month 24 Post-GAE Procedure

Population: Patient did not complete necessary follow-up visit to collect measure data.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Month 3 Post-GAE Procedure

Population: Outcome data not collected at Month 3 timepoint.

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 measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Month 6 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.

Outcome measures

Outcome measures
Measure	Patients With Post TKA Knee Pain n=1 Participants 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.
Change From Baseline in Quality of Life Measured Via EQ-5D-5L Score	19 Percentage change in EQ-5D-5L score

SECONDARY outcome

Timeframe: Baseline, Month 12 Post-GAE Procedure

Population: Patient did not complete necessary follow-up visit to collect measure data.

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 measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Month 24 Post-GAE Procedure

Population: Patient did not complete necessary follow-up visit to collect measure data.

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 measures

Outcome data not reported

SECONDARY outcome

Timeframe: Month 6 Post-GAE Procedure

Population: Outcome not assessed.

Incidence of synovitis measured using magnetic resonance angiogram images.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Month 24 Post-GAE Procedure

Population: Patient did not complete necessary follow-up visit to collect measure data.

Incidence of synovitis measured using magnetic resonance angiogram images.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Month 24 Post-GAE Procedure

Population: Patient did not complete necessary follow-up visit to collect measure data.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Month 24 Post-GAE Procedure

Population: Patient did not complete necessary follow-up visit to collect measure data.

Successful embolization defined as suppression or reduction in the filling of (blood flow in) abnormal vessels visible on angiography.

Outcome measures

Outcome data not reported

Adverse Events

Patients With Post TKA Knee Pain

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Bedros Taslakian, MD

NYU Langone Health

Phone: 332-237-9866

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place