Genicular Artery Embolization vs Nerve Ablation Intervention (GENI) for Knee Osteoarthritis
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- Who runs it
- David Clinkard
- Trial code
- NCT06166628
- Record updated
- 28 December 2023
- Original description
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).Read full original descriptionShow less
Efficacy of Genicular Artery Embolization Compared to Sensory Deinnervation for the Treatment of Symptomatic Knee Osteoarthritis: a Randomized Controlled Trial
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.
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 use of systemic immunosuppression therapy; Contraindication for MR Imaging (such as claustrophobia, metallic fragment or foreign bones, implants or prosthesis); Pregnancy or women of childbearing potential not currently on a medically acceptable method of birth control; Current local infection; Systemic or joint centered inflammatory disease (ie rheumatoid arthritis, Lupus, multiple sclerosis or other autoimmune diseases); Known lower extremity vascular disease or lower extremity symptoms thought to be secondary to arterial vascular disease (eg claudication, ischemic rest pain); IV CT and/or MRI contrast allergy characterized by anaphylaxis or anaphylactoid reactions; Renal dysfunction as defined by GFR (eGFR) of <30 obtained within the past 60 days; Irreversible coagulopathy.