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GonarthrosisNCT07879664

Bipolar Versus Cooled Radiofrequency Ablation for Gonarthrosis

A study testing Bipolar Radiofrequency Ablation and Cooled Radiofrequency Ablation in people with Gonarthrosis, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 40 to 75 years
Conditions the study is for
Gonarthrosis
What is being tested?
Bipolar Radiofrequency Ablation and Cooled Radiofrequency Ablation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 Nov 2026to 15 Apr 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Furkan Cetin, MD. contact

+905062726622

furkancetin58@gmail.com

Turkey (Türkiye)1 site
  • University Of Health Sciences, Gulhane School Of Medicine, Department Of Algology

    Ankara, Etlik, 06010

    Furkan Cetin, MD., +905062726622, furkancetin58@gmail.com

    Alp Eren Celenlioglu, MD./Assoc. Prof.

Other trials in Turkey (Türkiye)

About this study

Official title: A Comparative Study of Bipolar and Cooled Radiofrequency Ablation in Patients With Gonarthrosis

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.

Read the detailed description

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.

Conditions
Gonarthrosis
Being tested
Bipolar Radiofrequency Ablation, Cooled Radiofrequency Ablation
Keywords
gonarthrosis, genicular nerves, radiofrequency ablation, ultrasound
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bipolar Radiofrequency AblationProcedure or surgery

    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 AblationProcedure or surgery

    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.

Study groups in NCT07879664
Study groupRoleWhat they receive
Bipolar Radiofrequency AblationActive comparatorPatients undergo ultrasound-guided bipolar radiofrequency ablation of the superior medial, superior lateral, and inferior medial genicular nerves following a positive diagnostic genicular nerve block.
Receives: Procedure: Bipolar Radiofrequency Ablation
Cooled Radiofrequency AblationActive comparatorPatients undergo ultrasound-guided cooled radiofrequency ablation of the superior medial, superior lateral, and inferior medial genicular nerves following a positive diagnostic genicular nerve block.
Receives: Procedure: Cooled Radiofrequency Ablation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, 3 weeks, 12 weeks, and 24 weeks

  2. 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.

    Measured: Baseline, 3 weeks, 12 weeks, and 24 weeks

Secondary outcomes (3)
  1. 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.

    Measured: Baseline, 3 weeks, 12 weeks, and 24 weeks

  2. 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.

    Measured: Baseline, 3 weeks, 12 weeks, and 24 weeks

  3. 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.

    Measured: Baseline, 3 weeks, 12 weeks, and 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2026
  2. Study start20 Nov 2026 (estimated)
  3. Primary completion30 Mar 2027 (estimated)
  4. Study completion15 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants were assigned to either the BPRFA or CRFA group according to routine clinical practice and physician decision, and outcomes were prospectively compared between groups.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07879664
Sponsor's protocol ID
GEAH-ALGO-GENI-CRF-BRF-2026-03
Other IDs
AESH-EK-2025-236
Status last verified
Oct 2026
First submitted
18 May 2026
Last updated
19 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Oladeji LO, Cook JL. Cooled Radio Frequency Ablation for the Treatment of Osteoarthritis-Related Knee Pain: Evidence, Indications, and Outcomes. J Knee Surg. 2019 Jan;32(1):65-71. doi: 10.1055/s-0038-1675418. Epub 2018 Nov 5.

    PubMed 30396206
  • Kapural L, Deering JP. A technological overview of cooled radiofrequency ablation and its effectiveness in the management of chronic knee pain. Pain Manag. 2020 May;10(3):133-140. doi: 10.2217/pmt-2019-0066. Epub 2020 Mar 13.

    PubMed 32167418
  • Vanneste T, Belba A, Kallewaard JW, van Kuijk SMJ, Gelissen M, Emans P, Bellemans J, Smeets K, Terwiel C, Van Boxem K, Sommer M, Van Zundert J. Comparison of cooled versus conventional radiofrequency treatment of the genicular nerves for chronic knee pain: a multicenter non-inferiority randomized pilot trial (COCOGEN trial). Reg Anesth Pain Med. 2023 May;48(5):197-204. doi: 10.1136/rapm-2022-104054. Epub 2023 Jan 18.

    PubMed 36653065

Questions about this trial

What is this clinical trial studying?

A study testing Bipolar Radiofrequency Ablation and Cooled Radiofrequency Ablation in people with Gonarthrosis, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Furkan Cetin, MD. (+905062726622, furkancetin58@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Pain Intensity (time frame: Baseline, 3 weeks, 12 weeks, and 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07879664, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.

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