Genicular Artery Embolization as Pain Treatment of Knee Osteoarthritis

Study Overview
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Brief Summary
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The aim of this study is to investigate the safety and efficacy of geniculate artery embolization (GAE) as pain treatment in patients with mild to moderate knee osteoarthritis.

Detailed Description
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This is a single arm, prospective, pilot study investigating the safety and efficacy of GAE as pain treatment in patients with mild to moderate knee osteoarthritis. Patient related outcome measurements (PROMs), physical tests and several image modalities will be conducted. It may form the grounding for further research in the shape of a larger randomized clinical trial. The hypothesis is, that GAE will reduce synovitis and thereby pain in the patient group. This may secondary improve physical function and reduce consumption of analgesics.

Official Title
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Genicular Artery Embolization as Pain Treatment of Mild to Moderate Knee Osteoarthritis

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Procedure: Transarterial geniculate artery embolization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body Mass Index < 35 kg / m2. X-ray verified mild to moderate KOA (Kellgren Lawrence grade 1-3 [24]), obtained maximum 6 months prior to inclusion. Moderate to severe knee pain during walking (Visual Analog Scale (VAS) > 50 mm) - resistant to minimum 3 months physiotherapy. Willing, able, and mentally competent to provide informed consent. Exclusion Criteria: Local infection in knee or groin areas. Moderate to severe pain in ipsilateral lower limb joints; VAS > 2. Intermittent claudication. Rheumatoid arthritis or seronegative arthropathies. Prior ipsilateral open knee surgery. Ipsilateral arthroscopy within 6 months. Ipsilateral intra-articular knee injection within 6 months. Current/recent (within 4 weeks) use of oral corticosteroids. Generalized pain syndrome (e.g. fibromyalgia) or nerve root compression syndromes. Pregnant or planned pregnancy during the study period. Lactation. Active malignancy. Known history of allergy to contrast media. Contra-indications for MRI (e.g. metallic foreign bodies, etc). Manifest hyperthyroidism. Diabetes (I+II). Liver disease. Only one kidney, former kidney surgery, reduced kidney function or failure (chronic or acute). Estimated glomerular filtration rate < 60 ml / min / 1.73 m2 (All participants: blood sample maximum 30 days prior to GAE. Participants > 60 years: another blood sample maximum 3 months prior to last MRI scan with contrast agents). INR > 1.4, Platelets ≤ 40 x 109 / l (All participants: blood sample maximum 30 days prior to GAE). Antithrombotic treatment except acetylsalicylic acid. Diseases affecting the bone metabolism (E.g. severe osteoporosis, Paget's disease, or hyperparathyroidism). American Society of Anesthesiologists classification > 3.

Ages Eligible for Study
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Minimum Age: 30 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: Mild to moderate knee osteoarthritis (Kellgren Lawrence Score 1-3)<br>Geniculate artery embolization will be performed in all eligible participants. | Procedure: Transarterial geniculate artery embolization<br>* The procedure will be performed in local anaesthesia. An antegrade percutaneous transfemoral approach with super-selective catheterisation of geniculate neovesselswill be performed and subsequently the target will be pruned with microspherical embolic material.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Visual Analog Scale (VAS) as a measure of efficacy | Reported as worst pain experienced during walking in the last 24 hours on a 100 mm scale from No pain to Pain as bad as it could possibly be. | 6 months post GAE | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dexa scan | Changes in bone mineral density | Baseline vs 6 months post GAE | 
| Changes in Visual Analog Scale (VAS) as a measure of efficacy | Reported as worst pain experienced during walking in the last 24 hours on a 100 mm scale from No pain to Pain as bad as it could possibly be. | 1 week, 1, 2, 3, 4, and 5 months post GAE | 
| Changes in Knee injury and Osteoarthritis Outcome Score (KOOS) | KOOS assesses patient pain (9 items), other symptoms (7 items), function in daily living (17 items), function in sport and recreation (5 items), and knee related quality of life (4 items). Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms. | Baseline vs. 1 week, 1, 2, 3, 4, 5, and 6 months post GAE. | 
| Changes in IPAQ (international physical activity questionnaire) | Questionnaire on daily physical activity | Baseline vs. 1 week, 1, 2, 3, 4, 5, and 6 months post GAE | 
| Changes in use of analgesics | (paracetamol, NSAID, opioid, or neuropathic agent) | Baseline vs. 1 week, 1, 2, 3, 4, 5, and 6 months post GAE | 
| Changes in 30 seconds Chair Stand Test | The maximum number of chair stand repetitions in a 30 second period. | Baseline vs. 1 and 6 months post GAE. | 
| Changes in Stair Climb Test | The time (in seconds) it takes to ascend and descend a flight of stairs. | Baseline vs. 1 and 6 months post GAE. | 
| Changes in 40 meters Fast Paced Walk Test | A fast-paced walking test that is timed over 4*10 meters for a total of 40 meters. | Baseline vs. 1 and 6 months post GAE. | 
| Subjective response to the treatment on a five point Likert scale | (none=no good at all, ineffective treatment; poor=some effect but unsatisfactory; fair=reasonable effect but could be better; good=satisfactory effect with occasional episodes of pain or stiffness; excellent=ideal response, virtually pain free) | 6 months post GAE | 
| MRI | Changes in synovial thickness (CE-MRI), effusion (Non CE-MRI) and synovial perfusion (DCE-MRI). | Baseline vs. 1 and 6 months post GAE | 
| Ultrasound | Changes in synovial thickness, effusion and perfusion (doppler). | Baseline vs. 1 and 6 months post GAE | 

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