Geniculate Artery Embolization for the Treatment of Knee Osteoarthritis

University of Calgary50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Knee Osteoarthritis

Interventions

Geniculate Artery EmbolizationPROCEDURE

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.

Eligibility

Sex: ALLMin age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. VAS score of at least 50 mm for knee pain 2. Pain resistant to at least 3 months of conservative therapy (including medical therapy, physiotherapy, intra-articular cortisone or viscosupplement injection). 3. Age \> 40 years 4. Radiographs demonstrating knee osteoarthritis on same side as pain 5. Patient not a surgical candidate or declines surgical management Exclusion Criteria: 1. Radiographically severe knee osteoarthritis (Kellgren-Lawrence grade \>2) 2. Severe non-knee related lower limb pain with VAS \> 50 mm. 3. Local infection and inflammatory arthritis. 4. Malignancy 5. Previous knee surgery 6. 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 7. Known chronic renal failure or eGFR \< 45 8. ECOG grade \> 2 9. Patient weight \> 300 lbs 10. Patient unreliable for follow up

Outcomes

Primary Outcomes

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

Time frame: 3 months

Secondary Outcomes

Procedure related complications

To measure the incidence of minor and major procedure related adverse events

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 1, 3, and 6 months