Geniculate Artery Embolization for the Treatment of Knee Osteoarthritis

Study Overview
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Brief Summary
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Osteoarthritis (OA) is a highly prevalent degenerative joint disease that contributes to chronic pain and disability in approximately 10% of people over the age of 55. With 25% of Canadians expected to be aged 55 or older by 2036, an increasing number of Canadians will be impacted by knee OA. In affected individuals the risk of medical co-morbidities is increased which can lead to adverse cardiovascular outcomes, depression, and poorer quality of life. Current conservative therapy includes oral analgesia, lifestyle modification, corticosteroid injection, and viscosupplementation. These current conservative measures have variable responses. In patients who would prefer to avoid surgery or are not surgical candidates safe and consistently effective treatment options are lacking. Geniculate artery embolization (GAE) is a minimally invasive alternative with low risk of complications that has shown promise in exploratory studies. GAE provides benefit by disrupting angiogenesis in the knee which can contribute to chronic inflammation of the affected joint, and helps prevent the growth of new sensory nerve fibers which can reduce the pain associated with osteoarthritis.

Official Title
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Geniculate Artery Embolization for the Treatment of Knee Osteoarthritis

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Procedure: Geniculate Artery Embolization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: VAS score of at least 50 mm for knee pain Pain resistant to at least 3 months of conservative therapy (including medical therapy, physiotherapy, intra-articular cortisone or viscosupplement injection). Age > 40 years Radiographs demonstrating knee osteoarthritis on same side as pain Patient not a surgical candidate or declines surgical management Exclusion Criteria: Radiographically severe knee osteoarthritis (Kellgren-Lawrence grade >2) Severe non-knee related lower limb pain with VAS > 50 mm. Local infection and inflammatory arthritis. Malignancy Previous knee surgery Bleeding risk - known hematologic disease increasing risk of bleeding, pre-procedure INR > 1.4, pre-procedure PTT > 40 seconds or pre-procedure platelets < 50,000/uL Known chronic renal failure or eGFR < 45 ECOG grade > 2 Patient weight > 300 lbs Patient unreliable for follow up

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Geniculate Artery Embolization arm<br> | Procedure: Geniculate Artery Embolization<br>* The GAE procedure involves the use of an embolization agent to block blood flow to specific areas of the knee. Under sedo-analgesia, access to the target vessels is gained through the femoral or radial artery. GAE is performed with angiography to visualize blood vessels to assess the affected knee joint and ensure successful treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Reduction | To measure the proportion of patients achieving at least 50% pain reduction by the visual analogue pain score (VAS) after GAE for the treatment of pain due to knee osteoarthritis | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure related complications | To measure the incidence of minor and major procedure related adverse events | 30 days | 
| Pain Reduction | To measure the proportion of patients achieving at least 50% pain reduction by the visual analogue pain score (VAS) after GAE for the treatment of pain due to knee osteoarthritis | 1 month and 6 months | 
| Pain, stiffness and physical function | To measure the average improvement in the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) after GAE | 1, 3 and 6 months | 
| Pain medication required | 5. To measure proportion of patients achieving reduction in pain medication required, both in number and dose after GAE | 1, 3, and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Embolization