Clinical trial NCT04379700: Geniculate Artery Embolization for Treatment of Osteoarthritis
Official title: Feasibility and Safety of Geniculate Artery Embolization for Treatment of Mild to Moderate Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2020-05-07
Enrollment: 38
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Pain Score
timeFrame: Baseline, Month 3
Secondary outcomes:
measure: Change in WOMAC - Pain Score
timeFrame: Baseline, Month 1
measure: Change in WOMAC - Pain Score
timeFrame: Baseline, Month 12
measure: Change in Visual Analogue Scale (VAS) Rating of Knee Pain
timeFrame: Baseline, Month 1
measure: Change in VAS Rating of Knee Pain
timeFrame: Baseline, Month 3
measure: Change in VAS Rating of Knee Pain
timeFrame: Baseline, Month 12
measure: Change in WOMAC - Stiffness Score
timeFrame: Baseline, Month 1
measure: Change in WOMAC - Stiffness Score
timeFrame: Baseline, Month 3
measure: Change in WOMAC - Stiffness Score
timeFrame: Baseline, Month 12
measure: Change in WOMAC - Physical Function Score
timeFrame: Baseline, Month 1
measure: Change in WOMAC - Physical Function Score
timeFrame: Baseline, Month 3
measure: Change in WOMAC - Physical Function Score
timeFrame: Baseline, Month 12
measure: Change in WOMAC - Overall Score
timeFrame: Baseline, Month 1
measure: Change in WOMAC - Overall Score
timeFrame: Baseline, Month 3
measure: Change in WOMAC - Overall Score
timeFrame: Baseline, Month 12
measure: Change in Quality of Life Assessed Via 5-level EQ-5D Version (EQ-5D-5L)
timeFrame: Baseline, Month 1
measure: Change in Quality of Life Assessed Via EQ-5D-5L
timeFrame: Baseline, Month 3
measure: Change in Quality of Life Assessed Via EQ-5D-5L
timeFrame: Baseline, Month 12
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Bedros Taslakian, MD
role: PRINCIPAL_INVESTIGATOR
References: