Geniculate Artery Embolization for the Treatment of Knee Osteoarthritis

University of Calgary

Status: Enrolling

Conditions: Knee Osteoarthritis

Treatments: Procedure: Geniculate Artery Embolization

Study type: Interventional

Funder types: Other

Identifiers

NCT05386797

REB21-0641

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Geniculate Artery Embolization arm

Experimental group

Treatment:

Procedure: Geniculate Artery Embolization