An interventional study of Bipolar Radiofrequency Ablation and Cooled Radiofrequency Ablation in Gonarthrosis, sponsored by Saglik Bilimleri Universitesi. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Saglik Bilimleri Universitesi · Not applicable, Interventional, and Treatment
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.
Chronic knee osteoarthritis (gonarthrosis) is a major cause of persistent pain, reduced mobility, and impaired quality of life, particularly in older adults. Although conservative treatment options such as physical therapy, oral analgesics, and intra-articular injections are commonly used, many patients continue to experience significant pain and functional limitation. In recent years, genicular nerve radiofrequency ablation techniques have emerged as effective minimally invasive alternatives for patients who do not achieve adequate benefit from conservative management or are not suitable candidates for surgery.
Bipolar radiofrequency ablation (BPRFA) and cooled radiofrequency ablation (CRFA) are two radiofrequency techniques designed to create larger and more effective lesions around the genicular nerves, potentially improving denervation of the complex and variable sensory innervation of the knee joint. While both methods have shown promising results in the treatment of chronic knee osteoarthritis pain, direct comparative data regarding their clinical efficacy, functional outcomes, and safety profiles remain limited.
This prospective observational comparative study aims to evaluate and compare the analgesic efficacy and safety of ultrasound-guided BPRFA and CRFA in patients with chronic gonarthrosis refractory to conservative treatment. Patients with moderate-to-severe unilateral 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 as part of routine clinical practice.
Clinical outcomes are assessed using multiple validated outcome measures. Pain intensity is evaluated using the Numeric Rating Scale (NRS), functional status is assessed with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), kinesiophobia is evaluated using the Tampa Scale for Kinesiophobia (TSK), and quality of life is assessed using the 12-Item Short Form Health Survey (SF-12). Assessments are performed at baseline and during follow-up visits at 3, 12, and 24 weeks after treatment.
The study aims to compare pain reduction, functional recovery, quality-of-life improvement, treatment responder rates, and procedure-related adverse events between BPRFA and CRFA in patients with chronic knee osteoarthritis.
3,391 studies on the registry are indexed under Osteoarthritis, Knee; 628 are open to participants now.
This study's planned enrollment of 80 is above the median of 69 across 2,808 interventional studies indexed under Osteoarthritis, Knee.
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Patients with chronic knee osteoarthritis (gonarthrosis) who have persistent pain despite medical and conservative treatment and are considered appropriate candidates for radiofrequency ablation therapy will be included in the study after detailed explanation of the procedure and post-procedural follow-up process and after providing informed consent. Eligible participants must meet the following criteria:
Exclusion Criteria:
Patients undergo ultrasound-guided bipolar radiofrequency ablation of the superior medial, superior lateral, and inferior medial genicular nerves following a positive diagnostic genicular nerve block.
Procedure: Bipolar Radiofrequency Ablation
Patients undergo ultrasound-guided cooled radiofrequency ablation of the superior medial, superior lateral, and inferior medial genicular nerves following a positive diagnostic genicular nerve block.
Procedure: Cooled 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 (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.
Change in Pain Intensity
Pain intensity was assessed using the Numeric Rating Scale (NRS). Changes in NRS scores from baseline were evaluated after ultrasound-guided bipolar and cooled radiofrequency ablation of the genicular nerves.
Time frame: Baseline, 3 weeks, 12 weeks, and 24 weeks
Responder Rate Defined as ≥50% Reduction in NRS Scores
Treatment response was defined as a reduction of at least 50% in Numeric Rating Scale (NRS) scores compared with baseline values following treatment.
Time frame: Baseline, 3 weeks, 12 weeks, and 24 weeks
Functional improvement
Functional outcomes and quality of life were evaluated using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), including total, pain, stiffness, and function subscale scores.
Time frame: Baseline, 3 weeks, 12 weeks, and 24 weeks
Change in Quality of Life
Quality of life will be evaluated using the 12-Item Short Form Health Survey (SF-12). Changes in SF-12 scores compared with baseline values will be assessed during follow-up visits.
Time frame: Baseline, 3 weeks, 12 weeks, and 24 weeks
Change in Kinesiophobia
Kinesiophobia and fear of movement associated with chronic knee pain will be assessed using the Tampa Scale for Kinesiophobia (TSK). Changes in TSK scores from baseline following treatment will be evaluated during follow-up visits.
Time frame: Baseline, 3 weeks, 12 weeks, and 24 weeks
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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