Status:
RECRUITING
Genicular Artery Embolization vs Nerve Ablation Intervention (GENI) for Knee Osteoarthritis
Lead Sponsor:
David Clinkard
Collaborating Sponsors:
Queen's University
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
40+ years
Phase:
NA
Brief Summary
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 rece...
Detailed Description
Osteoarthritis (OA) of the knee is a common and debilitating disease. Advanced disease can be treated with total knee arthroplasty (TKA), however knee OA that is either resistant to non-surgical optio...
Eligibility Criteria
Inclusion
- Age \> 40 years
- Able to provide informed consent
- Knee pain due to osteoarthritis for at least 6 months
- Pain refractory to conservative therapies (oral medication, or physical therapy, or activity modification) for at least 3 months with a desire for TKA
- Candidate for TKA at Hotel Dieu Hospital Site
- Able to comply with all treatments and protocol follow-up visits
Exclusion
- Current local infection
- Systemic or joint centered inflammatory disease (ie rheumatoid arthritis, Lupus, multiple sclerosis or other autoimmune diseases)
- Current use of systemic immunosuppression therapy
- Known lower extremity vascular disease or lower extremity symptoms thought to be secondary to arterial vascular disease (eg claudication, ischemic rest pain)
- Irreversible coagulopathy
- Renal dysfunction as defined by GFR (eGFR) of \<30 obtained within the past 60 days
- Contraindication for MR Imaging (such as claustrophobia, metallic fragment or foreign bones, implants or prosthesis)
- IV CT and/or MRI contrast allergy characterized by anaphylaxis or anaphylactoid reactions
- Pregnancy or women of childbearing potential not currently on a medically acceptable method of birth control
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06166628
Start Date
December 1 2023
End Date
December 31 2026
Last Update
December 28 2023
Active Locations (1)
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1
Kingston Health Sciences Centre
Kingston, Ontario, Canada, K7L 2V7