Pilot Study: Geniculate Artery Embolization in Knee Osteoarthrosis.

Study Overview
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Brief Summary
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Geniculate Artery Embolization (GAE) has recently been described and studied as a palliative treatment for osteoarthrosis-related knee pain in patients un-eligible for surgical intervention. This treatment is based on the hypothesis that hypervascularization and associated increased nerve proliferation are possible sources of chronic pain following the morphological changes of osteoarthrosis. A large animal model has shown digital subtraction arteriography to be well correlated to both the histological findings of synovial inflammation and synovial contrast enhancement on magnetic resonance imaging. This embolization technique has also been applied to other regions of the musculoskeletal system including the elbow and the shoulder.

Detailed Description
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Primary Objective Confirm the efficacy and the effectiveness of geniculate artery embolization for pain control in knee osteoarthrosis. Secondary Objective Evaluate the effectiveness of geniculate artery embolization for pain control in specific population: young patients between 18 and 50 years old with advanced osteoarthritis (KL grade 3 or 4) for whom an orthopedic surgeon has deemed a total knee arthroplasty is not an appropriate therapy, and whom have failed conservative management for at least 6 months. Investigators propose a prospective pilot study on 40 patients with osteoarthrosis.

Official Title
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Pilot Study: Geniculate Artery Embolization in Knee Osteoarthrosis.

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Procedure: Geniculate Artery Embolization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years and older Moderate to severe knee pain (visual analog scale (VAS) > 70 mm) Pain refractory to at least 6 months of conservative therapies (anti-inflammatory drugs, or physical therapy, or muscle strengthening, or intra-articular injections) Localized pain on physical examination Kellgren-Lawrence (KL) Score on knee X-Ray Patients 50 years old and over : grade 1, 2, 3 or 4 18-50 years old: KL grade 3 or 4 Exclusion Criteria: Current local infection Life expectancy less than 6 months Known advanced atherosclerosis Rheumatoid or infectious arthritis Prior knee surgery Uncorrectable coagulopathy including international normalized ratio (INR) > 1.5 or platelets < 50,000 Iodine allergy Renal dysfunction as defined by GFR < 60ml/min obtained within the past 30 days. Diabetic patient Previous embolization of the geniculate arteries during the last year

Ages Eligible for Study
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Minimum Age: 18 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
Interventional Model Description: Patients will be stratified into two groups: Group 1: Patients between 18-50 years old with KL grade 3-4 Group 2: Patients age 50 years old and over with KL grade 1-4
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Geniculate Artery Embolization Arm<br>Single-arm prospective study of geniculate artery embolization for symptomatic knee osteoarthritis | Procedure: Geniculate Artery Embolization<br>* Conscious sedation : midazolam and fentanyl Local anesthesia : Lidocaine 2% subcutaneous Retrograde or anterograde common femoral artery access - 4Fr introducer Sub-therapeutic anticoagulation (heparin 2000 IU IA) Lower extremity arteriography Selective and supra-selective catheterization of geniculate arteries supplying painful region of the knee If abnormal arterial blushes are demonstrated selective and supra-selective embolization will be performed with Embozene microspheres (100 microns to 200 microns) - cold saline or ice-packs sac to be applied to overlying skin if significant cutaneous arteries are demonstrated at angiography. Angiographic end-points: embolization of abnormal blush while preserving the parent vessel Arteriotomy closure (manual compression or closure device)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain control VAS | The pain intensity is assessed using VAS (horizontal line 100 mm in length). Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing No Pain and 100 mm representing Worst Possible Pain. Expected mean VAS pre treatment: 7 Expected mean VAS at 1, 3, 6 and 12 months: 3-4 (50% reduction) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Function | Western Ontario and McMaster University Osteoarthritis Index (WOMAC) Subcategories of pain (5 items), stiffness (2 items), and physical function (17 items). Individuals select the level of difficulty they have performing various tasks using a 5 points Likert scale (0=None, 1=Slightly, 3=Very, 4=Extremely). Results are scored with a total maximum score of 96. A higher score indicates more difficulty in each of the categories. Expected mean WOMAC score pre treatment: 50 Expected mean WOMAC score at 1, 3, 6 and 12 months: 25 (50% reduction). | 12 months | 
| Radiological examinations | Knee x-ray examinations Knee MRI (if a complication is suspected clinically) Sustained response expected to be less likely with increased KL grade | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Embolization, Osteoarthritis, Knee, Geniculate Artery