๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2023-12-26

Genicular Artery Embolization vs Nerve Ablation Intervention (GENI) for Knee Osteoarthritis (NCT06166628)

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

๐ŸŸข Recruiting Observational / Diagnostic ๐Ÿฉบ Clinical Procedure Protocol Sponsor: David Clinkard

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Kingston Health Sciences Centre โ€” Kingston, Ontario

Age range: 40 Years

๐Ÿงช Interventions in This Study

  • Geniculate artery embolization (PROCEDURE)
  • Genicular nerve phenol nerve ablation (PROCEDURE)
  • Skin infiltration of 2cc of 0.25% bupivacaine at the knee (PROCEDURE)

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (1 Sites)

  • Kingston Health Sciences Centre โ€” Kingston, Ontario

๐Ÿ“ž Contact the Study Coordinator

Phone: (613) 549-6666

Email: david.clinkard@kingstonhsc.ca

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—