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Bipolar Versus Cooled Radiofrequency Ablation for Gonarthrosis
Sponsor: Saglik Bilimleri Universitesi
Summary
Patients with chronic knee osteoarthritis who do not respond adequately to conservative treatment may benefit from genicular nerve radiofrequency ablation procedures. Both bipolar radiofrequency ablation (BPRFA) and cooled radiofrequency ablation (CRFA) are minimally invasive techniques used to reduce pain and improve knee function by targeting the genicular nerves. However, comparative data regarding their clinical outcomes remain limited. This prospective observational comparative study aims to evaluate the analgesic efficacy and safety of ultrasound-guided BPRFA and CRFA in patients with chronic gonarthrosis. Patients with moderate-to-severe chronic knee pain who achieve significant pain relief following diagnostic genicular nerve block subsequently undergo either BPRFA or CRFA targeting the superior medial, superior lateral, and inferior medial genicular nerves under ultrasound guidance. Pain intensity, functional status, kinesiophobia, and quality of life are assessed using the Numeric Rating Scale (NRS), the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), the Tampa Scale for Kinesiophobia (TSK), and the 12-Item Short Form Health Survey (SF-12) at baseline and during follow-up evaluations at 3, 12, and 24 weeks after treatment. The study compares pain reduction, functional improvement, treatment responder rates, quality-of-life outcomes, and procedure-related adverse events between the two treatment modalities.
Official title: A Comparative Study of Bipolar and Cooled Radiofrequency Ablation in Patients With Gonarthrosis
Key Details
Gender
All
Age Range
40 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2026-11-20
Completion Date
2027-04-15
Last Updated
2026-10-19
Healthy Volunteers
No
Conditions
Interventions
Bipolar Radiofrequency Ablation
Patients with chronic knee osteoarthritis refractory to conservative treatment will initially undergo an ultrasound-guided diagnostic genicular nerve block to assess treatment responsiveness. The superior medial, superior lateral, and inferior medial genicular nerves will be identified using anatomical landmarks and Doppler-confirmed genicular arteries with the Alpinion® E-Cube 8 Diamond ultrasound system equipped with a 3-12 MHz linear transducer. Following negative aspiration, a mixture of local anesthetics will be injected around each target nerve. Patients achieving at least 50% pain reduction for a minimum of 3 hours after the diagnostic block will subsequently undergo bipolar radiofrequency ablation (Bi-RFA). Bi-RFA procedures will be performed under sterile ultrasound guidance using the COOLIEF™ Cooled RF Advanced Generator. Two parallel 21-gauge radiofrequency cannulas with 10-mm active tips will be positioned adjacent to each target nerve to create larger bipolar lesions. App
Cooled Radiofrequency Ablation
Cooled radiofrequency ablation (C-RFA) will be performed under ultrasound guidance with linear transducer. Procedures will be carried out using the COOLIEF™ Cooled RF Advanced Generator (Avanos Medical®, USA). Continuous cooling of the probe tip with a saline circulation system enables the creation of larger lesions while maintaining tissue temperature at approximately 60°C. Patients achieving at least 50% pain relief following the diagnostic genicular nerve block will undergo C-RFA targeting the superior medial, superior lateral, and inferior medial genicular nerves. Following sterile preparation and local anesthesia with 2% lidocaine, a cooled radiofrequency probe will be advanced to the target site under ultrasound guidance. Sensory and motor stimulation will be performed to confirm accurate needle placement before cooled thermal ablation is applied at 60°C for 150 seconds. Patients will be monitored for possible complications after the procedure.
Locations (1)
University Of Health Sciences, Gulhane School Of Medicine, Department Of Algology
Ankara, Etlik, Turkey (Türkiye)