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NCT07879664
Bipolar Versus Cooled Radiofrequency Ablation for Gonarthrosis
Conditions: Gonarthrosis
Sex: All
Ages: 40 Years – 75 Years
Healthy volunteers: No
Phase: NA
Enrollment: 80
Sponsor: Saglik Bilimleri Universitesi
Location: University Of Health Sciences, Gulhane School Of Medicine, Department Of Algology Ankara Etlik
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.
Eligibility Criteria
Inclusion Criteria:
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:
* Age between 40 and 75 years
* Unilateral moderate-to-severe knee pain related to gonarthrosis (Numeric -Rating Scale \[NRS\] ≥6)
* Persistent pain for longer than 6 months
* Radiological evidence of Kellgren-Lawrence grade 2, 3, or 4 osteoarthritis
* Inadequate response to conservative treatment modalities, including analgesic medications, intra-articular injections, and physical therapy
* Impairment of daily living activities due to knee pain
Exclusion Criteria:
* Refusal to undergo the procedure or provide informed consent
* Knee pain unrelated to osteoarthritis or absence of pain localized to the target knee region
* Knee pain secondary to other conditions such as fracture, trauma, spinal disorders, or inflammatory arthritis
* History of surgical intervention involving the target knee within the previous 6 months
* History of intra-articular injection to the target knee within the previous 3 months, including corticosteroids, platelet-rich plasma, stem cell therapy, or hyaluronic acid
* Absence of moderate-to-severe radiological gonarthrosis findings
* Cognitive impairment limiting reliable assessment or cooperation
* Hepatic or renal failure
* Severe psychiatric disorders
* Local or systemic infection
* Coagulopathy
* Current use of antiplatelet or anticoagulant medications
* Presence of a cardiac pacemaker
Source: ClinicalTrials.gov (NCT07879664). StuddyBuddy aggregates publicly available trial information.