OsteoarthritisNCT04379700
Geniculate Artery Embolization for Treatment of Osteoarthritis
A study testing Transcatheter arterial embolization and Embozene™ Microspheres in people with Osteoarthritis, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Transcatheter arterial embolization and Embozene™ Microspheres
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2020to 12 Mar 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 30-80 years of age of any gender;
- 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;
- 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);
- 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).
- Willing, able, and mentally competent to provide informed consent and complete study questionnaires in English. The Study questionnaire is validated in English.
Who cannot join
- Active systemic or local knee infection;
- Active malignancy;
- Life expectancy less than 12 months;
- 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;
- Ipsilateral knee intra-articular injection in the last 3 months;
- Rheumatoid arthritis, spondyloarthropathies, crystal disease, gout, pseudogout, or lupus;
Show all 15Show fewer
- Pregnant during the study period;
- Renal dysfunction as defined by serum creatinine >1.6 dl/mg or eGFR <60 on blood tests obtained within 30 days of procedure;
- Body weight greater than 200 Kg;
- Uncorrectable coagulopathy (platelet count < 50,000, international normalized ratio >1.5 within 30 days of procedure;
- Known history of contrast allergy resulting in anaphylaxis;
- 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);
- Post-traumatic knee (if trauma occurred within 12 months of baseline or was associated with fractures);
- Known avascular necrosis in the target knee;
- Contraindications to MRI such as such as claustrophobia, metallic fragment/implants, pacemaker.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Safety of Geniculate Artery Embolization for Treatment of Mild to Moderate Knee Osteoarthritis
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.
Read the 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.
- Conditions
- Osteoarthritis
- Being tested
- Transcatheter arterial embolization, Embozene™ Microspheres
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter arterial embolizationProcedure or surgery
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™ MicrospheresDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Embolization Group | Experimental | 23 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. Receives: Procedure: Transcatheter arterial embolization; Device: Embozene™ Microspheres |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Month 3
Secondary outcomes (17)
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.
Measured: Baseline, Month 1
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.
Measured: Baseline, Month 12
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".
Measured: Baseline, Month 1
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".
Measured: Baseline, Month 3
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".
Measured: Baseline, Month 12
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.
Measured: Baseline, Month 1
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.
Measured: Baseline, Month 3
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.
Measured: Baseline, Month 12
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.
Measured: Baseline, Month 1
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.
Measured: Baseline, Month 3
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.
Measured: Baseline, Month 12
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.
Measured: Baseline, Month 1
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.
Measured: Baseline, Month 3
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.
Measured: Baseline, Month 12
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).
Measured: Baseline, Month 1
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).
Measured: Baseline, Month 3
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).
Measured: Baseline, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study start1 Dec 2020
- Primary completion12 Mar 2025
- Study completion12 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bedros Taslakian, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04379700
- Sponsor's protocol ID
- 19-00370
- Status last verified
- Jun 2025
- First submitted
- 6 May 2020
- Last updated
- 18 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: This is a small scale, single-site research study for NYU
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Safety of Geniculate Artery Embolization for Treatment of Mild to Moderate Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04379700
- Acronym / sponsor ID
- 19-00370
- Conditions
- Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 12 Mar 2025 (actual)
- Study completion
- 12 Mar 2025 (actual)
- First posted
- 7 May 2020 (actual)
- Results
- Posted 31 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Embolization Group | Experimental | Procedure: Transcatheter arterial embolization, Device: Embozene™ Microspheres23 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. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 30-80 years of age of any gender;
- 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;
- 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);
- 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).
- Willing, able, and mentally competent to provide informed consent and complete study questionnaires in English. The Study questionnaire is validated in English.
Key exclusion criteria (15 listed)
- Active systemic or local knee infection;
- Active malignancy;
- Life expectancy less than 12 months;
- 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;
- Ipsilateral knee intra-articular injection in the last 3 months;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcatheter arterial embolizationTranscatheter 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. | Procedure or surgery | Embolization Group |
| Embozene™ MicrospheresEmbozene™ 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. | Device | Embolization Group |
Primary outcome
Percentage Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Pain Score
Time frame: 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.
17 secondary outcomes
Change in WOMAC - Pain Score
Time frame: Baseline, Month 1
Change in WOMAC - Pain Score
Time frame: Baseline, Month 12
Change in Visual Analogue Scale (VAS) Rating of Knee Pain
Time frame: Baseline, Month 1
Change in VAS Rating of Knee Pain
Time frame: Baseline, Month 3
Change in VAS Rating of Knee Pain
Time frame: Baseline, Month 12
Change in WOMAC - Stiffness Score
Time frame: Baseline, Month 1
Change in WOMAC - Stiffness Score
Time frame: Baseline, Month 3
Change in WOMAC - Stiffness Score
Time frame: Baseline, Month 12
Change in WOMAC - Physical Function Score
Time frame: Baseline, Month 1
Change in WOMAC - Physical Function Score
Time frame: Baseline, Month 3
Change in WOMAC - Physical Function Score
Time frame: Baseline, Month 12
Change in WOMAC - Overall Score
Time frame: Baseline, Month 1
Change in WOMAC - Overall Score
Time frame: Baseline, Month 3
Change in WOMAC - Overall Score
Time frame: Baseline, Month 12
Change in Quality of Life Assessed Via 5-level EQ-5D Version (EQ-5D-5L)
Time frame: Baseline, Month 1
Change in Quality of Life Assessed Via EQ-5D-5L
Time frame: Baseline, Month 3
Change in Quality of Life Assessed Via EQ-5D-5L
Time frame: Baseline, Month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. This is a small scale, single-site research study for NYU
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bedros Taslakian, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcatheter arterial embolization and Embozene™ Microspheres in people with Osteoarthritis, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Pain Score (time frame: Baseline, Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2025.