NCT03835988

Geniculate Artery Embolization for Knee Osteoarthritis

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Calgary · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

A prospective cohort study to study the effectiveness and safety profile of geniculate artery embolization for the treatment of symptomatic knee osteoarthritis.

Detailed description

Purpose: The investigators aim to determine whether geniculate artery embolization is a safe treatment for symptomatic knee osteoarthritis and confirm published reports of sustained post-procedural pain relief, improved physical function and investigate potential improvements in joint function quantitatively through imaging and targeted assessments. Participants:Twenty patients with moderate to severe knee pain, pain refractory for 3 months of conservative therapies, imaging features of symptomatic osteoarthritis and ineligible for arthroplasty for 1 year. Procedures (methods): Patients will undergo a brief clinical evaluation to verify eligibility through inclusion and exclusion criteria in addition to a comprehensive joint pain treatment history will be recorded including active analgesic and anti-inflammatory use. A pre-procedural MRI will be completed to assess the extent of their osteoarthritis, signs of active synovitis and vascular anatomy of the knee. Evaluations post geniculate artery embolization will occur at 24 hours, 1, 6 and 12 months to assess for changes in knee pain and joint function and monitor adverse events. An MRI will be performed at the 6 month visit to detect changes in synovitis and exclude complications.

Conditions

• Osteo Arthritis Knee

Interventions

Type	Name	Description
DEVICE	Geniculate Artery Embolization	Embolization is a procedure completed by an Interventional Radiologist in which abnormal blood vessels are blocked for treatment purposes. In the case of geniculate artery embolization, abnormal blood vessels which supply your knee joint are blocked in an effort to reduce inflammation and subsequently and reduce pain and improve joint function.

Timeline

• Start date: 2019-03-01
• Primary completion: 2021-04-01
• Completion: 2021-12-31
• First posted: 2019-02-11
• Last updated: 2021-04-28

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated device study