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Genicular Artery Embolization vs Nerve Ablation Intervention (GENI) for Knee Osteoarthritis

RecruitingNAAges 40 Years - anyAllDavid Clinkard
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In plain words

What the trial is, and whether it could suit you

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) a

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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
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What it tests

  • Geniculate artery embolization
  • Genicular nerve phenol nerve ablation
  • Skin infiltration of 2cc of 0.25% bupivacaine at the knee
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Where

1 site
Kingston Health Sciences Centre
Kingston, Canada
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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