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
๐ฉบ 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
๐งช 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)
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (1 Sites)
- Kingston Health Sciences Centre โ Kingston, Ontario
๐ 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.
๐ฐ 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.
More studies in Knee Osteoarthritis
- A Trial to Investigate the Safety and Efficacy of Intra-articular 4P004 Injection in Subjects With Knee Synovitis and Osteoarthritis โ Tucson, Arizona
- Dronabinol After Arthroscopic Surgery โ Chicago, Illinois
- Telehealth Stepped Exercise Program for Rural Veterans With Knee Osteoarthritis โ Durham, North Carolina
- Microfragmented Adipose Tissue Compared to Saline Injection for the Treatment of Knee Osteoarthritis โ Phoenix, Arizona
- Early Outcomes of MAKO Medial Unicompartmental Knee Arthroplasty โ St Louis, Missouri
- GAE Using Embosphere Microspheres vs Corticosteroid Injections for Treatment of Symptomatic Knee OA (MOTION) โ Long Beach, California
Explore by condition: All Knee Osteoarthritis clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.