Comparing two treatments for knee osteoarthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Kingston Health Sciences Centre
  Kingston, Ontario, Canada Recruiting

Study contacts

• Principal investigator: David Clinkard, MD — Queen's University
• Study coordinator: David Clinkard, MD
• Email: david.clinkard@kingstonhsc.ca
• Phone: 613-549-6666

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.