Using Genicular Radiofrequency Ablation to Treat Knee Pain After Knee Replacement
The Safety and Efficacy of Genicular Radiofrequency Ablation for Patients With Persistent Knee Pain Following Total Knee Arthroplasty - A Triple Blinded Randomized Sham-Controlled Trial
This study is testing a new treatment called Genicular Radiofrequency Ablation to see if it can help people with ongoing knee pain after knee replacement surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | University of Calgary Academic / other |
| Locations | 1 site (Calgary, Alberta) |
| Trial ID | NCT05283889 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety and effectiveness of Genicular Radiofrequency Ablation (GRFA) in patients experiencing persistent knee pain following total knee arthroplasty (TKA). It will involve a triple-blinded, randomized, sham-controlled design where participants will be assigned to receive either the GRFA treatment or a sham procedure. The study will assess pain levels and functional outcomes at multiple time points post-treatment, utilizing various measurement tools to gauge improvements. The research seeks to provide a minimally invasive solution for patients suffering from refractory knee pain after TKA.
Who should consider this trial
Good fit: Ideal candidates are individuals who are more than one year post-TKA and have persistent knee pain that is unresponsive to conventional treatments.
Not a fit: Patients with infections, prosthetic failures, or severe psychiatric conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce knee pain and improve quality of life for patients with unresolved pain after knee replacement surgery.
How similar studies have performed: Previous studies have shown favorable outcomes for similar interventions, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * \>1 year post TKA * persistent knee pain \> 4/10 in intensity on average over the prior week of one of the post-TKA knees * refractory to conventional treatment (i.e., physiotherapy, medication, etc.) * ≥80% pain relief with a single fluoroscopically guided local anesthetic block using 0.5 mL of 2% lidocaine for the medial and lateral branches of the nerve to the vastus intermedialis, nerve to the vastus lateralis\*, inferior medial genicular nerve, infrapatellar branch of the saphenous nerve, and the recurrent fibular nerve. 0.5 mL will be injected over 2 spots (1.5 cm apart) for each of the superior medial and lateral genicular nerves corresponding to the sites of the RF cannulae for the bipolar strip lesions. \*Blocks will be combined fluoroscopy/ultrasound guided. Exclusion Criteria: * Infection (peri-prosthetic, joint, systemic, skin/soft tissue overlying the knee to be treated) * Prosthetic loosening or failure, periprosthetic fracture * Severe psychiatric disorder * Non-genicular lower extremity pain source from the spine (i.e., radiculopathy or neurogenic claudication) or peripheral joints (i.e., hip osteoarthritis) * Peripheral vascular disease causing vascular claudication * Connective tissue/inflammatory joint disease/widespread soft tissue pain disorder * Poor tolerance of injection procedures (as observed from the prognostic local anesthetic blocks) * Allergy to local anesthetic, synovial expansion into the anticipated path(s) of the local anesthetic needle/RF cannula as determined by ultrasound scanning * Uncontrolled bleeding diathesis * Pregnancy * Pacemaker or neurostimulator * Inability to complete Patient-Reported Outcome Measures due to cognitive or language limitations.
Where this trial is running
Calgary, Alberta
- Vivo Cura Health — Calgary, Alberta, Canada (Recruiting)
Study contacts
- Principal investigator: Ashley Smith, PhD — University of Calgary
- Study coordinator: Jennifer Laxshimalla
- Email: jennifer.laxshimalla@vivocura.ca
- Phone: 4032653838
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.