Geniculate Artery Embolization for Treatment of Osteoarthritis

NYU Langone Health38 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Osteoarthritis

Interventions

Transcatheter arterial embolizationPROCEDURE

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.

Eligibility

Sex: ALLMin age: 30 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

NYU Langone Health

New York, New York, United States

Outcomes

Primary Outcomes

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

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

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".

Data from ClinicalTrials.gov

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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

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

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

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

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

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

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)

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

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

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