NCT06166628 Genicular Artery Embolization vs Nerve Ablation Intervention (GENI) for Knee Osteoarthritis
| NCT ID | NCT06166628 |
| Status | Recruiting |
| Phase | — |
| Sponsor | David Clinkard |
| Condition | Knee Osteoarthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2023-12-01 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2023-12-01 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
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
Contact & Investigator
David Clinkard, MD
PRINCIPAL INVESTIGATOR
Queen's University
Frequently Asked Questions
Who can join the NCT06166628 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Knee Osteoarthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06166628 currently recruiting?
Yes, NCT06166628 is actively recruiting participants. Contact the research team at david.clinkard@kingstonhsc.ca for enrollment information.
Where is the NCT06166628 trial being conducted?
This trial is being conducted at Kingston, Canada.
Who is sponsoring the NCT06166628 clinical trial?
NCT06166628 is sponsored by David Clinkard. The principal investigator is David Clinkard, MD at Queen's University. The trial plans to enroll 150 participants.