NCT07879664Not yet recruiting
Bipolar Versus Cooled Radiofrequency Ablation for Gonarthrosis
A Comparative Study of Bipolar and Cooled Radiofrequency Ablation in Patients With Gonarthrosis
Source: ClinicalTrials.gov · Last updated 19 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 18 May 2026
- Start date
- 20 Nov 2026
- Primary completion date
- 30 Mar 2027
- Lead sponsor
- Saglik Bilimleri Universitesi
- NCT number
- NCT07879664
What you commit to
- Study type: Interventional
- Planned participants: 80
- From 20 Nov 2026 to the primary completion date, 30 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of surgical intervention involving the target knee within the previous 6 months
- Current use of antiplatelet or anticoagulant medications
Other illness
- Knee pain secondary to other conditions such as fracture, trauma, spinal disorders, or inflammatory arthritis
- Cognitive impairment limiting reliable assessment or cooperation
- Hepatic or renal failure
- Severe psychiatric disorders
- Local or systemic infection
- Presence of a cardiac pacemaker
Lab values
- 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
Other
- Refusal to undergo the procedure or provide informed consent
- Knee pain unrelated to osteoarthritis or absence of pain localized to the target knee region
- Absence of moderate-to-severe radiological gonarthrosis findings
- Coagulopathy
Who the study is looking for
- 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
Age in the registry: 40 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Of Health Sciences, Gulhane School Of Medicine, Department Of Algology Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.