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

Knee Osteoarthritis

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.

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Conditions de participation

  • Sexe:

    ALL

  • Âges admissibles:

    40 and up

Critères de participation

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

Lieu de l'étude

Kingston Health Sciences Centre
Kingston Health Sciences Centre
Kingston, Ontario
Canada

Contactez l'équipe d'étude

Primary Contact

David Clinkard, MD

[email protected]
613-549-6666
Étude parrainée par
Queen's University
Participants recherchés
Plus d'informations
ID de l'étude: NCT06166628