Feasibility and Safety of Geniculate Artery Embolization for Treatment of Mild to Moderate Knee Osteoarthritis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- NYU Langone Health
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Percentage Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Pain Score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •30-80 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);
- •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).
- •Willing, able, and mentally competent to provide informed consent and complete study questionnaires in English. The Study questionnaire is validated in English.
Exclusion Criteria
- •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.
Arms & Interventions
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.
Intervention: Transcatheter arterial embolization (Procedure)
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.
Intervention: Embozene™ Microspheres (Device)
Outcomes
Primary Outcomes
Percentage Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Pain Score
Time Frame: Baseline, Month 3
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.
Secondary Outcomes
- 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 12)
- Change in WOMAC - Stiffness Score(Baseline, Month 12)
- Change in WOMAC - Physical Function Score(Baseline, Month 12)
- Change in WOMAC - Overall Score(Baseline, Month 12)
- Change in Quality of Life Assessed Via 5-level EQ-5D Version (EQ-5D-5L)(Baseline, Month 1)
- Change in Quality of Life Assessed Via EQ-5D-5L(Baseline, Month 12)
- Change in WOMAC - Pain Score(Baseline, Month 1)
- Change in VAS Rating of Knee Pain(Baseline, Month 3)
- Change in WOMAC - Stiffness Score(Baseline, Month 1)
- Change in WOMAC - Stiffness Score(Baseline, Month 3)
- Change in WOMAC - Physical Function Score(Baseline, Month 1)
- Change in WOMAC - Physical Function Score(Baseline, Month 3)
- Change in WOMAC - Overall Score(Baseline, Month 1)
- Change in WOMAC - Overall Score(Baseline, Month 3)
- Change in Quality of Life Assessed Via EQ-5D-5L(Baseline, Month 3)