NCT04113681

Pilot Study: Geniculate Artery Embolization in Knee Osteoarthrosis.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Maisonneuve-Rosemont Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

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 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.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
PROCEDURE	Geniculate Artery Embolization	1. Conscious sedation : midazolam and fentanyl 2. Local anesthesia : Lidocaine 2% subcutaneous 3. Retrograde or anterograde common femoral artery access - 4Fr introducer 4. Sub-therapeutic anticoagulation (heparin 2000 IU IA) 5. Lower extremity arteriography 6. Selective and supra-selective catheterization of geniculate arteries supplying painful region of the knee 7. If abnormal arterial blushes are demonstrated selective and supra-selective embolization will be performed with Embozene microspheres (100 microns to 200 microns) - cold saline or ice-packs sac to be applied to overlying skin if significant cutaneous arteries are demonstrated at angiography. 8. Angiographic end-points: embolization of abnormal blush while preserving the parent vessel 9. Arteriotomy closure (manual compression or closure device)

Timeline

• Start date: 2019-02-14
• Primary completion: 2021-06-01
• Completion: 2021-12-31
• First posted: 2019-10-03
• Last updated: 2021-03-08

Locations

1 site across 1 country: Canada