Geniculate Artery Embolization for Treatment of Osteoarthritis

NCT04379700 | Completed Results DMC FDA Device

• 1 other identifier: 19-00370
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• Change in WOMAC - Pain Score

  Baseline, Month 1

• Change in WOMAC - Pain Score

  Baseline, Month 12

• Change in Visual Analogue Scale (VAS) Rating of Knee Pain

  Baseline, Month 1

• Change in VAS Rating of Knee Pain

  Baseline, Month 3

• Change in VAS Rating of Knee Pain

  Baseline, Month 12

Study Arms (1)

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.

Procedure: Transcatheter arterial embolization; Device: Embozene™ Microspheres

Interventions

Transcatheter arterial embolization PROCEDURE

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.

Embolization Group

Embozene™ Microspheres DEVICE

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.

Embolization Group

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• Willing, able, and mentally competent to provide informed consent and complete study questionnaires in English. The Study questionnaire is validated in English.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10013, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Bedros Taslakian, MD
• Organization: NYU Langone Health

bedros.taslakian@nyulangone.org

212-263-5898

Study Officials

• Bedros Taslakian, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2020
• First Posted: May 7, 2020
• Study Start: December 1, 2020
• Primary Completion: March 12, 2025
• Study Completion: March 12, 2025
• Last Updated: June 18, 2025
• Results First Posted: May 31, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)