Knee PainNCT06134817
Geniculate Artery Embolization for Treatment of Persistent Knee Pain Post Total Knee Arthroplasty
A study testing Embozene Color-Advanced Microspheres. in people with Knee Pain, 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 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). Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Knee Pain
- What is being tested?
- Embozene Color-Advanced Microspheres.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 24 May 2024to 12 Feb 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 14Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Pilot Study on Geniculate Artery Embolization for Treatment of Persistent Knee Pain Post Total Knee Arthroplasty
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.
- Conditions
- Knee Pain
- Being tested
- Embozene Color-Advanced Microspheres.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Embozene Color-Advanced Microspheres. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Month 6 Post-GAE Procedure
Secondary outcomes (16)
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.
Measured: Baseline, Month 3 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Month 24 Post-GAE Procedure
Incidence of Synovitis
Incidence of synovitis measured using magnetic resonance angiogram images.
Measured: Month 6 Post-GAE Procedure
Incidence of Synovitis
Incidence of synovitis measured using magnetic resonance angiogram images.
Measured: Month 24 Post-GAE Procedure
Incidence of Successful Selective Catheterization of Target Genicular Artery
Measured: 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.
Measured: Up to Month 24 Post-GAE Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start24 May 2024
- Primary completion12 Feb 2025
- Study completion12 Feb 2025
Why it stopped: Departure of PI.
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 Knee PainStudies 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
- 2 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
- NCT06134817
- Sponsor's protocol ID
- 23-00595
- Status last verified
- Aug 2025
- First submitted
- 13 Nov 2023
- Last updated
- 7 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Pilot Study on Geniculate Artery Embolization for Treatment of Persistent Knee Pain Post Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT06134817
- Acronym / sponsor ID
- 23-00595
- Conditions
- Knee Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Departure of PI.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 24 May 2024 (actual)
- Primary completion
- 12 Feb 2025 (actual)
- Study completion
- 12 Feb 2025 (actual)
- First posted
- 18 Nov 2023 (actual)
- Results
- Posted 7 Aug 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Post TKA Knee Pain | Experimental | Device: Embozene Color-Advanced Microspheres.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. |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (14 listed)
- 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;
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 |
|---|---|---|
| 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. | Device | Patients with Post TKA Knee Pain |
Primary outcome
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Score From Baseline to Month 6
Time frame: 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.
16 secondary outcomes
Change From Baseline in KOOS Symptoms Score
Time frame: Baseline, Month 3 Post-GAE Procedure
Change From Baseline in KOOS Symptoms Score
Time frame: Baseline, Month 6 Post-GAE Procedure
Change From Baseline in KOOS Symptoms Score
Time frame: Baseline, Month 12 Post-GAE Procedure
Change From Baseline in KOOS Symptoms Score
Time frame: Baseline, Month 24 Post-GAE Procedure
Change From Baseline in Knee Pain Measured Via Visual Analogue Scale (VAS)
Time frame: Baseline, Month 3 Post-GAE Procedure
Change From Baseline in Knee Pain Measured Via VAS
Time frame: Baseline, Month 6 Post-GAE Procedure
Change From Baseline in Knee Pain Measured Via VAS
Time frame: Baseline, Month 12 Post-GAE Procedure
Change From Baseline in Knee Pain Measured Via VAS
Time frame: Baseline, Month 24 Post-GAE Procedure
Change From Baseline in Quality of Life Measured Via EuroQol-5 Dimension-5 Level (EQ-5D-5L) Score
Time frame: Baseline, Month 3 Post-GAE Procedure
Change From Baseline in Quality of Life Measured Via EQ-5D-5L Score
Time frame: Baseline, Month 6 Post-GAE Procedure
Change From Baseline in Quality of Life Measured Via EQ-5D-5L Score
Time frame: Baseline, Month 12 Post-GAE Procedure
Change From Baseline in Quality of Life Measured Via EQ-5D-5L Score
Time frame: Baseline, Month 24 Post-GAE Procedure
Incidence of Synovitis
Time frame: Month 6 Post-GAE Procedure
Incidence of Synovitis
Time frame: Month 24 Post-GAE Procedure
Incidence of Successful Selective Catheterization of Target Genicular Artery
Time frame: Up to Month 24 Post-GAE Procedure
Incidence of Successful Embolization From at Least One Feeding Artery of the Knee Joint
Time frame: Up to Month 24 Post-GAE Procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Knee Pain
Recruiting
Effects of Telerehabilitation Versus Supervised Rehabilitation Protocol on Pain, Range of Motion and Functional Recovery in Patients With Patellofemoral Pain Syndrome.
Patello Femoral Pain Syndrome
RecruitingPhase 3
A Study to Learn About Study Medicine Called Berobenatide in Adults With Knee Pain and Overweight or Obesity (VESPER-OA 1)
Obesity, Overweight
Recruiting
BioPoly® Partial Resurfacing Knee Implant IDE
Knee Pain Chronic, Knee Osteoarthritis
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
RecruitingObservational study
MRI Study of Musculoskeletal Function
Abnormalities, Imaging
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 Embozene Color-Advanced Microspheres. in people with Knee Pain, 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 3 inclusion and 14 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: stopped early, as of the sponsor's last update on 7 Aug 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 7 Aug 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?
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Score From Baseline to Month 6 (time frame: Baseline, Month 6 Post-GAE Procedure). 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 7 Aug 2025.