Osteoarthritis
Conditions
Brief summary
Single-arm, single-center, no sham or placebo, prospective pilot trial designed to evaluate the feasibility and safety of transcatheter arterial embolization in patients with mild to moderate radiographic knee OA. Eligible participants will receive geniculate artery embolization using Embozene™ Color-Advanced Microspheres. Patients will be followed up for a total of 12 months.
Detailed description
The current study seeks to determine whether transcatheter arterial embolization of abnormal neovasculature arising from the genicular arterial branches is safe and effective in the treatment of mild-to-moderate knee OA.
Interventions
PROCEDURETranscatheter arterial embolization
Transcatheter arterial embolization of one or more genicular artery(ies) using Embozene™ Color-Advanced Microspheres. Embozene™ Color-Advanced Microspheres are spherical, tightly calibrated, biocompatible, non-resorbable, hydrogel microspheres coated with an inorganic perfluorinated polymer used for embolization.
DEVICEEmbozene™ Microspheres
Embozene™ Microspheres are spherical, tightly calibrated, biocompatible, nonresorbable, hydrogel microspheres coated with an inorganic perfluorinated polymer (Polyzene™-F). The microspheres intended to occlude vasculature for the purpose of blocking blood flow to a target tissue. They are available in prefilled syringes in a range of sizes suitable for embolic therapy. The microspheres are compressible to enable smooth delivery through the indicated delivery catheter and color-coded by size to allow for easy identification. 250 μm microsphere will be used and are supplied in prefilled yellow syringes.
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 80 Years
Healthy volunteers
No
Inclusion criteria
1. 30-80 years of age of any gender; 2. Kellgren-Lawrence Grade 2, 3, or 4 (in select subjects who have no bony deformity) knee OA on most recent knee radiograph obtained within 6 months of screening visit; 3. Knee pain resistant to conservative treatment for at least 3 months (anti- inflammatory drugs, acetaminophen, physical therapy, muscle strengthening, or intra- articular injection of hyaluronic acid and/or steroids); 4. Moderate to severe knee pain: pain VAS ≥ 40 mm with 0 representing 'no pain' and 100 'the worst pain imaginable. If both knees meet inclusion criteria, the one with a higher VAS score will be chosen for the study (i.e., target knee). 5. Willing, able, and mentally competent to provide informed consent and complete study questionnaires in English. The Study questionnaire is validated in English.
Exclusion criteria
1. Active systemic or local knee infection; 2. Active malignancy; 3. Life expectancy less than 12 months; 4. Prior ipsilateral knee surgery (within 3 years of baseline visit), arthroscopic surgery (within 6 months of baseline), total or partial knee replacement regardless of timing; 5. Ipsilateral knee intra-articular injection in the last 3 months; 6. Rheumatoid arthritis, spondyloarthropathies, crystal disease, gout, pseudogout, or lupus; 7. Pregnant during the study period; 8. Renal dysfunction as defined by serum creatinine \>1.6 dl/mg or eGFR \<60 on blood tests obtained within 30 days of procedure; 9. Body weight greater than 200 Kg; 10. Uncorrectable coagulopathy (platelet count \< 50,000, international normalized ratio \>1.5 within 30 days of procedure; 11. Known history of contrast allergy resulting in anaphylaxis; 12. 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); 13. Post-traumatic knee (if trauma occurred within 12 months of baseline or was associated with fractures); 14. Known avascular necrosis in the target knee; 15. Contraindications to MRI such as such as claustrophobia, metallic fragment/implants, pacemaker.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Pain Score | Baseline, Month 3 | The WOMAC questionnaire includes 24 questions on daily activities. The Pain Score subsection includes five questions regarding pain (pain during walking, stair climbing, nocturnal, rest, weight bearing); each question is scored on a Likert scale as follow: 0 for no pain, 1 for mild, 2 for moderate, 3 for severe, and 4 for extreme pain. The total score is the sum of responses and ranges from 0-20; higher scores indicate greater pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in WOMAC - Pain Score | Baseline, Month 1 | The WOMAC questionnaire includes 24 questions on daily activities. The Pain Score subsection includes five questions regarding pain (pain during walking, stair climbing, nocturnal, rest, weight bearing); each question is scored on a Likert scale as follow: 0 for no pain, 1 for mild, 2 for moderate, 3 for severe, and 4 for extreme pain. The total score is the sum of responses and ranges from 0-20; higher scores indicate greater pain. |
| Change in Visual Analogue Scale (VAS) Rating of Knee Pain | Baseline, Month 1 | The electronic VAS is a horizontal line with no markings on the scale except No pain on the left (score: 0 mm) and worst possible pain on the right end of the scale (score: 100 mm). Subjects mark the VAS to indicate their current pain level, with 0 mm representing No pain and 100 mm representing worst possible pain. |
| Change in VAS Rating of Knee Pain | Baseline, Month 3 | The electronic VAS is a horizontal line with no markings on the scale except No pain on the left (score: 0 mm) and worst possible pain on the right end of the scale (score: 100 mm). Subjects mark the VAS to indicate their current pain level, with 0 mm representing No pain and 100 mm representing worst possible pain. |
| Change in WOMAC - Stiffness Score | Baseline, Month 1 | The WOMAC - Stiffness Score is calculated using the Knee Injury and Osteoarthritis Outcome Score (KOOS) extension to the WOMAC score. The Stiffness Score comprises 2 items related to knee stiffness; both items are rated on a Likert scale from 0-4; the total score is the sum of responses and ranges from 0-8. Higher scores indicate more severe knee stiffness. |
| Change in WOMAC - Physical Function Score | Baseline, Month 1 | The WOMAC - Physical Function Score is calculated using the KOOS extension to the WOMAC score. The Physical Function Score comprises 17 items related to function in daily life and in sports/recreation; all items are rated on a Likert scale from 0-4; the total score is the sum of responses and ranges from 0-68. Higher scores indicate more severe dehabilitation. |
| Change in WOMAC - Overall Score | Baseline, Month 1 | The WOMAC questionnaire includes 24 questions on daily activities. All items are rated on a scale from 0-4. The total score is the sum of responses and ranges from 0-96. A higher overall WOMAC score indicates greater pain, stiffness, and functional limitations. |
| Change in Quality of Life Assessed Via 5-level EQ-5D Version (EQ-5D-5L) | Baseline, Month 1 | Quality of life reported by the patient measured using the 6-item EQ-5D-5L measure. EQ-5D-5L states are converted into an index value; index values range from full health (1) to no health (-0.109). |
| Change in Quality of Life Assessed Via EQ-5D-5L | Baseline, Month 3 | Quality of life reported by the patient measured using the 6-item EQ-5D-5L measure. EQ-5D-5L states are converted into an index value; index values range from full health (1) to no health (-0.109). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Embolization Group Participants who are aged between 30 to 75 years old, with grade 2 or 3 knee OA on the most recent knee radiographs obtained within 6 months of intervention. Each individual participant will be enrolled for approximately 13 months to complete all study visits from the initial screening visit to last follow up at 12-months post intervention.
Transcatheter arterial embolization: Transcatheter arterial embolization of one or more genicular artery(ies) using Embozene™ Color-Advanced Microspheres. Embozene™ Color-Advanced Microspheres are spherical, tightly calibrated, biocompatible, non-resorbable, hydrogel microspheres coated with an inorganic perfluorinated polymer used for embolization.
Embozene™ Microspheres: Embozene™ Microspheres are spherical, tightly calibrated, biocompatible, nonresorbable, hydrogel microspheres coated with an inorganic perfluorinated polymer (Polyzene™-F). The microspheres intended to occlude vasculature for the purpose of blocking blood flow to a target tissue. They are available in prefilled syringes in a range of sizes suitable for embolic therapy. The microspheres are compressible to enable smooth delivery through the indicated delivery catheter and color-coded by size to allow for easy identification. 250 μm microsphere will be used and are supplied in prefilled yellow syringes. | 25 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Screen Fail | 4 |
| Overall Study | Withdrawal by Subject | 10 |
Baseline characteristics
| Characteristic | Embolization Group |
|---|---|
| Age, Continuous | 65.2 years STANDARD_DEVIATION 7.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 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 | 5 Participants |
| Race (NIH/OMB) White | 17 Participants |
| Region of Enrollment United States | 25 participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 11 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
Primary
Percentage Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Pain Score
The WOMAC questionnaire includes 24 questions on daily activities. The Pain Score subsection includes five questions regarding pain (pain during walking, stair climbing, nocturnal, rest, weight bearing); each question is scored on a Likert scale as follow: 0 for no pain, 1 for mild, 2 for moderate, 3 for severe, and 4 for extreme pain. The total score is the sum of responses and ranges from 0-20; higher scores indicate greater pain.
Time frame: Baseline, Month 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Embolization Group | Percentage Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Pain Score | -50.1 Percentage change | Standard Deviation 26.4 |
Secondary
Change in Quality of Life Assessed Via 5-level EQ-5D Version (EQ-5D-5L)
Quality of life reported by the patient measured using the 6-item EQ-5D-5L measure. EQ-5D-5L states are converted into an index value; index values range from full health (1) to no health (-0.109).
Time frame: Baseline, Month 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Embolization Group | Change in Quality of Life Assessed Via 5-level EQ-5D Version (EQ-5D-5L) | 19.80 Percentage change | Standard Deviation 24.8 |
Secondary
Change in Quality of Life Assessed Via EQ-5D-5L
Quality of life reported by the patient measured using the 6-item EQ-5D-5L measure. EQ-5D-5L states are converted into an index value; index values range from full health (1) to no health (-0.109).
Time frame: Baseline, Month 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Embolization Group | Change in Quality of Life Assessed Via EQ-5D-5L | 20.6 Percentage change | Standard Deviation 20 |
Secondary
Change in Quality of Life Assessed Via EQ-5D-5L
Quality of life reported by the patient measured using the 6-item EQ-5D-5L measure. EQ-5D-5L states are converted into an index value; index values range from full health (1) to no health (-0.109).
Time frame: Baseline, Month 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Embolization Group | Change in Quality of Life Assessed Via EQ-5D-5L | 17.6 Percentage change | Standard Deviation 21 |
Secondary
Change in VAS Rating of Knee Pain
The electronic VAS is a horizontal line with no markings on the scale except No pain on the left (score: 0 mm) and worst possible pain on the right end of the scale (score: 100 mm). Subjects mark the VAS to indicate their current pain level, with 0 mm representing No pain and 100 mm representing worst possible pain.
Time frame: Baseline, Month 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Embolization Group | Change in VAS Rating of Knee Pain | -55.40 Percentage change | Standard Deviation 3770 |
Secondary
Change in VAS Rating of Knee Pain
The electronic VAS is a horizontal line with no markings on the scale except No pain on the left (score: 0 mm) and worst possible pain on the right end of the scale (score: 100 mm). Subjects mark the VAS to indicate their current pain level, with 0 mm representing No pain and 100 mm representing worst possible pain.
Time frame: Baseline, Month 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Embolization Group | Change in VAS Rating of Knee Pain | -50.80 Percentage change | Standard Deviation 37.9 |
Secondary
Change in Visual Analogue Scale (VAS) Rating of Knee Pain
The electronic VAS is a horizontal line with no markings on the scale except No pain on the left (score: 0 mm) and worst possible pain on the right end of the scale (score: 100 mm). Subjects mark the VAS to indicate their current pain level, with 0 mm representing No pain and 100 mm representing worst possible pain.
Time frame: Baseline, Month 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Embolization Group | Change in Visual Analogue Scale (VAS) Rating of Knee Pain | -48.50 Percentage change | Standard Deviation 33.6 |
Secondary
Change in WOMAC - Overall Score
The WOMAC questionnaire includes 24 questions on daily activities. All items are rated on a scale from 0-4. The total score is the sum of responses and ranges from 0-96. A higher overall WOMAC score indicates greater pain, stiffness, and functional limitations.
Time frame: Baseline, Month 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Embolization Group | Change in WOMAC - Overall Score | -48 Percentage change | Standard Deviation 34.5 |
Secondary
Change in WOMAC - Overall Score
The WOMAC questionnaire includes 24 questions on daily activities. All items are rated on a scale from 0-4. The total score is the sum of responses and ranges from 0-96. A higher overall WOMAC score indicates greater pain, stiffness, and functional limitations.
Time frame: Baseline, Month 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Embolization Group | Change in WOMAC - Overall Score | -47.50 Percentage change | Standard Deviation 32.3 |
Secondary
Change in WOMAC - Overall Score
The WOMAC questionnaire includes 24 questions on daily activities. All items are rated on a scale from 0-4. The total score is the sum of responses and ranges from 0-96. A higher overall WOMAC score indicates greater pain, stiffness, and functional limitations.
Time frame: Baseline, Month 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Embolization Group | Change in WOMAC - Overall Score | -48.10 Percentage change | Standard Deviation 35.5 |
Secondary
Change in WOMAC - Pain Score
The WOMAC questionnaire includes 24 questions on daily activities. The Pain Score subsection includes five questions regarding pain (pain during walking, stair climbing, nocturnal, rest, weight bearing); each question is scored on a Likert scale as follow: 0 for no pain, 1 for mild, 2 for moderate, 3 for severe, and 4 for extreme pain. The total score is the sum of responses and ranges from 0-20; higher scores indicate greater pain.
Time frame: Baseline, Month 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Embolization Group | Change in WOMAC - Pain Score | -39.6 Percentage change | Standard Deviation 36.7 |
Secondary
Change in WOMAC - Pain Score
The WOMAC questionnaire includes 24 questions on daily activities. The Pain Score subsection includes five questions regarding pain (pain during walking, stair climbing, nocturnal, rest, weight bearing); each question is scored on a Likert scale as follow: 0 for no pain, 1 for mild, 2 for moderate, 3 for severe, and 4 for extreme pain. The total score is the sum of responses and ranges from 0-20; higher scores indicate greater pain.
Time frame: Baseline, Month 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Embolization Group | Change in WOMAC - Pain Score | -43.70 Percentage change | Standard Deviation 48.9 |
Secondary
Change in WOMAC - Physical Function Score
The WOMAC - Physical Function Score is calculated using the KOOS extension to the WOMAC score. The Physical Function Score comprises 17 items related to function in daily life and in sports/recreation; all items are rated on a Likert scale from 0-4; the total score is the sum of responses and ranges from 0-68. Higher scores indicate more severe dehabilitation.
Time frame: Baseline, Month 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Embolization Group | Change in WOMAC - Physical Function Score | -49.90 Percentage change | Standard Deviation 35.4 |
Secondary
Change in WOMAC - Physical Function Score
The WOMAC - Physical Function Score is calculated using the KOOS extension to the WOMAC score. The Physical Function Score comprises 17 items related to function in daily life and in sports/recreation; all items are rated on a Likert scale from 0-4; the total score is the sum of responses and ranges from 0-68. Higher scores indicate more severe dehabilitation.
Time frame: Baseline, Month 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Embolization Group | Change in WOMAC - Physical Function Score | -47.8 Percentage change | Standard Deviation 47.8 |
Secondary
Change in WOMAC - Physical Function Score
The WOMAC - Physical Function Score is calculated using the KOOS extension to the WOMAC score. The Physical Function Score comprises 17 items related to function in daily life and in sports/recreation; all items are rated on a Likert scale from 0-4; the total score is the sum of responses and ranges from 0-68. Higher scores indicate more severe dehabilitation.
Time frame: Baseline, Month 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Embolization Group | Change in WOMAC - Physical Function Score | -51.20 Percentage change | Standard Deviation 32.5 |
Secondary
Change in WOMAC - Stiffness Score
The WOMAC - Stiffness Score is calculated using the Knee Injury and Osteoarthritis Outcome Score (KOOS) extension to the WOMAC score. The Stiffness Score comprises 2 items related to knee stiffness; both items are rated on a Likert scale from 0-4; the total score is the sum of responses and ranges from 0-8. Higher scores indicate more severe knee stiffness.
Time frame: Baseline, Month 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Embolization Group | Change in WOMAC - Stiffness Score | -43.30 Percentage change | Standard Deviation 45.3 |
Secondary
Change in WOMAC - Stiffness Score
The WOMAC - Stiffness Score is calculated using the Knee Injury and Osteoarthritis Outcome Score (KOOS) extension to the WOMAC score. The Stiffness Score comprises 2 items related to knee stiffness; both items are rated on a Likert scale from 0-4; the total score is the sum of responses and ranges from 0-8. Higher scores indicate more severe knee stiffness.
Time frame: Baseline, Month 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Embolization Group | Change in WOMAC - Stiffness Score | -35 Percentage change | Standard Deviation 50.4 |
Secondary
Change in WOMAC - Stiffness Score
The WOMAC - Stiffness Score is calculated using the Knee Injury and Osteoarthritis Outcome Score (KOOS) extension to the WOMAC score. The Stiffness Score comprises 2 items related to knee stiffness; both items are rated on a Likert scale from 0-4; the total score is the sum of responses and ranges from 0-8. Higher scores indicate more severe knee stiffness.
Time frame: Baseline, Month 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Embolization Group | Change in WOMAC - Stiffness Score | -39.80 Percentage change | Standard Deviation 41.5 |