Actively Recruiting
Genicular Artery Embolization vs Nerve Ablation Intervention (GENI) for Knee Osteoarthritis
Led by David Clinkard · Updated on 2023-12-28
150
Participants Needed
1
Research Sites
160 weeks
Total Duration
On this page
Sponsors
D
David Clinkard
Lead Sponsor
Q
Queen's University
Collaborating Sponsor
AI-Summary
What this Trial Is About
The genicular artery embolization vs nerve ablation intervention (GENI) knee OA study is a three-arm randomized controlled trial to evaluate symptoms of knee osteoarthritis (OA) in patients after receiving one of three interventions: sham procedure, geniculate artery embolization (GAE) or genicular nerve phenol nerve ablation (PNA). The main question\[s\] the study aims to answer are: * Does GAE or genicular nerve PNA result in OA symptom alleviation compared to sham procedure? * Are there molecular or imaging biomarkers that aid in predicting treatment response for GAE or genicular nerve PNA? Subjects (N=150) patients with knee OA, resistant to non-surgical treatment for at least 3 months will be randomized 1:1:1 to either after GAE, genicular nerve PNA or sham procedure. Clinical outcomes will be measured using Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and 11-point numerical rating scale (NRS) for pain completed at baseline, 1 month, 3 months, and 6 months and then every 6 months for either two years or until the time of total knee arthroplasty (TKA) surgery.
CONDITIONS
Official Title
Genicular Artery Embolization vs Nerve Ablation Intervention (GENI) for Knee Osteoarthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 40 years
- Able to provide informed consent
- Knee pain due to osteoarthritis for at least 6 months
- Pain resistant to oral medication, physical therapy, or activity modification for at least 3 months
- Candidate for total knee arthroplasty at the study hospital
- Able to follow all treatments and attend follow-up visits
You will not qualify if you...
- Current local infection
- Systemic or joint inflammatory diseases such as rheumatoid arthritis, lupus, multiple sclerosis, or other autoimmune diseases
- Current use of systemic immunosuppressive therapy
- Known lower extremity vascular disease or symptoms from arterial disease (e.g., claudication, ischemic rest pain)
- Irreversible blood clotting disorders
- Kidney dysfunction with eGFR less than 30 within past 60 days
- Contraindications for MRI (e.g., claustrophobia, metallic fragments, implants, prostheses)
- Allergy to IV CT or MRI contrast causing severe reactions
- Pregnancy or women of childbearing potential not using medically accepted birth control
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Kingston Health Sciences Centre
Kingston, Ontario, Canada, K7L 2V7
Actively Recruiting
Research Team
D
David Clinkard, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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