Knee Pain
Conditions
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.
Interventions
DEVICEEmbozene 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.
Sponsors
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 85 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Knee Pain Measured Via Visual Analogue Scale (VAS) | 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. |
| Change From Baseline in Knee Pain Measured Via VAS | 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. |
| Change From Baseline in Quality of Life Measured Via EuroQol-5 Dimension-5 Level (EQ-5D-5L) Score | Baseline, Month 3 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. |
| Change From Baseline in KOOS Symptoms Score | 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. |
| Incidence of Synovitis | Month 6 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 | — |
| 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. |
| Change From Baseline in Quality of Life Measured Via EQ-5D-5L Score | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 1 |
| Total | 1 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Departure - termination of study | 1 |
Baseline characteristics
| Characteristic | Patients With Post TKA Knee Pain |
|---|---|
| Age, Continuous | 74 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Region of Enrollment United States | 1 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1 |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
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.
Time frame: Baseline, Month 6 Post-GAE Procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With Post TKA Knee Pain | Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Score From Baseline to Month 6 | 20 Percent change in KOOS Pain score |
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.
Time frame: Baseline, Month 24 Post-GAE Procedure
Population: Patient did not complete necessary follow-up visit to collect measure data.
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.
Time frame: Baseline, Month 6 Post-GAE Procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With Post TKA Knee Pain | Change From Baseline in Knee Pain Measured Via VAS | 46 Percentage change in VAS score |
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.
Time frame: Baseline, Month 12 Post-GAE Procedure
Population: Patient did not complete necessary follow-up visit to collect measure data.
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.
Time frame: Baseline, Month 3 Post-GAE Procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With Post TKA Knee Pain | Change From Baseline in Knee Pain Measured Via Visual Analogue Scale (VAS) | 42 Percentage change in VAS score |
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.
Time frame: Baseline, Month 24 Post-GAE Procedure
Population: Patient did not complete necessary follow-up visit to collect measure data.
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.
Time frame: Baseline, Month 3 Post-GAE Procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With Post TKA Knee Pain | Change From Baseline in KOOS Symptoms Score | 23 Percentage change in KOOS Symptoms score |
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.
Time frame: Baseline, Month 6 Post-GAE Procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With Post TKA Knee Pain | Change From Baseline in KOOS Symptoms Score | 31 Percentage change in KOOS Symptoms score |
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.
Time frame: Baseline, Month 12 Post-GAE Procedure
Population: Patient did not complete necessary follow-up visit to collect measure data.
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.
Time frame: Baseline, Month 12 Post-GAE Procedure
Population: Patient did not complete necessary follow-up visit to collect measure data.
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.
Time frame: Baseline, Month 24 Post-GAE Procedure
Population: Patient did not complete necessary follow-up visit to collect measure data.
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.
Time frame: Baseline, Month 6 Post-GAE Procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With Post TKA Knee Pain | Change From Baseline in Quality of Life Measured Via EQ-5D-5L Score | 19 Percentage change in EQ-5D-5L score |
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.
Time frame: Baseline, Month 3 Post-GAE Procedure
Population: Outcome data not collected at Month 3 timepoint.
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.
Time frame: Up to Month 24 Post-GAE Procedure
Population: Patient did not complete necessary follow-up visit to collect measure data.
Secondary
Incidence of Successful Selective Catheterization of Target Genicular Artery
Time frame: Up to Month 24 Post-GAE Procedure
Population: Patient did not complete necessary follow-up visit to collect measure data.
Secondary
Incidence of Synovitis
Incidence of synovitis measured using magnetic resonance angiogram images.
Time frame: Month 24 Post-GAE Procedure
Population: Patient did not complete necessary follow-up visit to collect measure data.
Secondary
Incidence of Synovitis
Incidence of synovitis measured using magnetic resonance angiogram images.
Time frame: Month 6 Post-GAE Procedure
Population: Outcome not assessed.