Comparing two treatments for knee osteoarthritis

Efficacy of Genicular Artery Embolization Compared to Sensory Deinnervation for the Treatment of Symptomatic Knee Osteoarthritis: a Randomized Controlled Trial

This study is testing two different treatments for knee osteoarthritis to see if they can help people with knee pain feel better compared to a fake procedure.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: Queen's University (other)
• Locations: 1 site (Kingston, Ontario)
• Trial ID: NCT06166628 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of genicular artery embolization (GAE) and genicular nerve phenol nerve ablation (PNA) in alleviating symptoms of knee osteoarthritis (OA) compared to a sham procedure. It is a three-arm randomized controlled trial involving 150 participants who have experienced knee pain for at least six months and have not responded to conservative treatments. Participants will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and a numerical rating scale for pain at multiple time points. Additionally, the study aims to identify biomarkers that may predict treatment response.

Who should consider this trial

Good fit: Ideal candidates are individuals over 40 years old with knee osteoarthritis pain that has not improved with conservative therapies for at least three months.

Not a fit: Patients with systemic inflammatory diseases, current infections, or contraindications for MR imaging may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide new, effective treatment options for patients suffering from chronic knee osteoarthritis pain.

How similar studies have performed: While GAE and nerve ablation have shown promise in preliminary studies, this is one of the first randomized controlled trials directly comparing these two interventions.

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

Where this trial is running

Kingston, Ontario

• Kingston Health Sciences Centre — Kingston, Ontario, Canada (RECRUITING)

Study contacts

• Principal investigator: David Clinkard, MD — Queen's University
• Study coordinator: David Clinkard, MD

Conditions: Knee Osteoarthritis, Artery embolization, Nerve ablation, Genicular Artery Embolization