Geniculate Artery Embolization for Treatment of Osteoarthritis

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Procedure: Transcatheter arterial embolization; Device: Embozene™ Microspheres

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 Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10013
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Embolization Group; 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.

Procedure: 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.; Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Month 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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".	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".	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".	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.	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.	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.	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.	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.	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.	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.	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.	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.	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).	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).	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).	Baseline, Month 12

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Bedros Taslakian, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): March 12, 2025
• Study Completion (Actual): March 12, 2025

Study Registration Dates

• First Submitted: May 6, 2020
• First Submitted That Met QC Criteria: May 6, 2020
• First Posted (Actual): May 7, 2020

Study Record Updates

• Last Update Posted (Actual): June 18, 2025
• Last Update Submitted That Met QC Criteria: June 2, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis
• Other Study ID Numbers: 19-00370

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a small scale, single-site research study for NYU

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes