Geniculate Artery Embolization for Treatment of Osteoarthritis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Feasibility and Safety of Geniculate Artery Embolization for Treatment of Mild to Moderate Knee Osteoarthritis

Conditions
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Osteoarthritis

Intervention / Treatment
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* Procedure: Transcatheter arterial embolization
* Device: Embozene™ Microspheres


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Embolization Group<br>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<br>* 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.<br>Device: Embozene™ Microspheres<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Knee pain using Western Ontario and McMaster Universities Osteoarthritis index (WOMAC) score | Western Ontario and McMaster Universities Osteoarthritis index (WOMAC) questionnaire has 24 questions on daily activities. WOMAC pain score includes five questions regarding pain (pain during walking, stair climbing, nocturnal, rest, weight bearing); each question will be scored suing the following points: 0 for no pain, 1 for mild, 2 for moderate, 3 for severe, and 4 for extreme pain. possible score ranges for pain are 0-20. WOMAC Score will be calculated from the Knee injury and Osteoarthritis Outcome Score (KOOS) score which was developed as an extension of the WOMAC score with the purpose of evaluating short-term and long-term symptoms and function in subjects with knee injury and osteoarthritis. | Baseline, 1 month, 3 month and 12 month follow up visits | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Knee pain using the Visual Analogue Scale (VAS) scale | The change in knee pain will be assessed by the Visual Analogue Scale (VAS) scale which is a validated, subjective measure for acute and chronic 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, 1 month, 3 month and 12 month follow up visits | 
| Change in Knee Stiffness | Knee stiffness will be measured through the KOOS questionnaire to obtain the WOMAC score. The Knee injury and Osteoarthritis Outcome Score (KOOS) was developed as an extension of the WOMAC Osteoarthritis Index with the purpose of evaluating short-term and long-term symptoms and function in subjects with knee injury and osteoarthritis. The KOOS holds five separately scored subscales: Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). | Baseline, 1 month, 3 month and 12 month follow up visits | 
| Change in Physical Functioning | Physical functioning will be measured through the KOOS questionnaire to obtain the WOMAC score. The Knee injury and Osteoarthritis Outcome Score (KOOS) was developed as an extension of the WOMAC Osteoarthritis Index with the purpose of evaluating short-term and long-term symptoms and function in subjects with knee injury and osteoarthritis. The KOOS holds five separately scored subscales: Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). | Baseline, 1 month, 3 month and 12 month follow up visits | 
| Change in Quality of life | The EQ-5D-5L is a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. This tool also has an overall health scale where the rater selects a number between 1-100 to describe the condition of their health, 100 being the best imaginable. | Baseline, 1 month, 3 month and 12 month follow up visits |