Status:
UNKNOWN
Pilot Study: Geniculate Artery Embolization in Knee Osteoarthrosis.
Lead Sponsor:
Maisonneuve-Rosemont Hospital
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 trea...
Detailed 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 ar...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04113681
Start Date
February 14 2019
End Date
December 31 2021
Last Update
March 8 2021
Active Locations (1)
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1
CIUSSS de l'Est-de-l'Île-de-Montréal, Installation Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada, H1T 2M4