Pilot Study: Geniculate Artery Embolization in Knee Osteoarthrosis.

Maisonneuve-Rosemont Hospital

Status: Unknown

Conditions: Osteoarthritis, Knee

Treatments: Procedure: Geniculate Artery Embolization

Study type: Interventional

Funder types: Other

Identifiers

NCT04113681

Geniculate embolization.

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Geniculate Artery Embolization Arm

Experimental group

Description:

Single-arm prospective study of geniculate artery embolization for symptomatic knee osteoarthritis

Treatment:

Procedure: Geniculate Artery Embolization