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RadiofrequencyNCT07381335

Phenol Neurolysis and Radiofrequency Thermocoagulation in Knee Arthroplasty Surgery

A study testing genicular nerve radiofrequency thermocoagulation and fenole neurolysis in people with Radiofrequency and Arthroplasty, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Patients who presented to the Department of Neurology, Algology, and underwent knee arthroplasty surgery for chronic knee osteoarthritis between 2025 and 2026 and underwent radiofrequency or chemical neurolysis of the geniculate nerve due to pain will be studied in two groups. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Radiofrequency, Arthroplasty, Knee Osteoarthritis
What is being tested?
genicular nerve radiofrequency thermocoagulation and fenole neurolysis
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Sep 2025to Jun 2026
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 Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Inclusion criteria were patients over the age of 18 who had undergone arthroplasty for chronic knee osteoarthritis.Exclusion Criteria:

Who cannot join

  • Patients with severe systemic diseases, local infections or injuries, and those allergic to any of the injection materials were excluded from the study.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Esra Ertilav

    Aydin, Efeler/Aydın, 09100

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of the Efficacy of Phenol Neurolysis and Radiofrequency Thermocoagulation Applied to the Geniculate Nerve on Pain in Patients Undergoing Knee Arthroplasty Surgery

Patients who presented to the Department of Neurology, Algology, and underwent knee arthroplasty surgery for chronic knee osteoarthritis between 2025 and 2026 and underwent radiofrequency or chemical neurolysis of the geniculate nerve due to pain will be studied in two groups. The groups will be randomly assigned by the clinician using computer-aided designation, and the patients will be allocated to the two groups. Patients in Group 1 will receive radiofrequency thermocoagulation of the geniculate nerve. Patients in Group 2 will receive phenol neurolysis of the geniculate nerve. Patients with pacemakers will be included in the phenol neurolysis group (Group 2), and patients with a phenol allergy will be included in the radiofrequency group (Group 1).

During the study, NRS and WOMAC measurements will be performed on patients in Groups 1 and 2 to assess pain intensity before the procedure and at 1, 3, and 6 months post-procedure. Neurological and musculoskeletal system examinations will be performed during routine check-ups before the procedure and at 1, 3 and 6 months after the procedure, and any developing side effects will be recorded.

Read the detailed description

140 patients who underwent arthroplasty for chronic knee osteoarthritis will be evaluated in the Algology Department of the Neurology Department at Adnan Menderes University Hospitals between October 2025 and May 2026. Inclusion criteria include patients over the age of 18 who underwent arthroplasty for chronic knee osteoarthritis. Written informed consent will be obtained from all participants. Patients with severe systemic diseases, local infections, or injuries, and those allergic to any of the injection materials will be excluded. All patients will be clinically evaluated (a detailed history, including personal data, medical history, and current treatments). Procedural procedures will be performed in a sterile operating room environment. Patients are positioned supine, and a pillow is placed under the popliteal fossa to support the knee. After visualizing the tibiofemoral joint with fluoroscopy, the potential locations of the geniculate nerves in the medial and lateral regions of the distal femur and medial tibia will be identified with fluoroscopy. After sterile conditions are achieved, local anesthesia is administered both subcutaneously and transcutaneously. A 5 cm long, 5 mm active tip RFT cannula (NeuroThermTM, Medipoint GmbH, Hamburg, Germany) is placed for each geniculate nerve using anteroposterior and lateral fluoroscopy images. For the superior lateral geniculate nerve, it is advanced toward the attachment of the femoral shaft and lateral condyle, for the superior medial geniculate nerve toward the distal femoral diaphysis, and for the inferior medial geniculate nerve toward the proximal tibial diaphysis and medial tibial condyle, ensuring bone contact. The cannula is positioned midline between the diaphysis of the femur and tibia using the lateral image. Sensory stimulation at 50 Hz and motor stimulation at 2 Hz are then applied, followed by a 2 cc 0.5% bupivacaine block for each geniculate nerve. Each cannula is lesioned for 90 seconds using an 80-degree conventional RFT generator (Neurotherm NT1100 / 13001-12).

In the phenol neurolysis group, a 22-gauge, 3.5-inch Quincke needle is advanced toward the junction of the femoral shaft and lateral condyle for the superior lateral genicular nerve; toward the distal femoral diaphysis for the superior medial genicular nerve; and toward the proximal tibial diaphysis and medial tibial condyle for the inferior medial genicular nerve, ensuring bone contact. Lateral imaging confirms the cannula's position in the midline of the diaphysis of the femur and tibia. A mixture of 6 cc of 0.25% bupivacaine and 6% phenol is injected into each geniculate nerve. Post-procedure complications and side effects (infection, bleeding, neurological deficit, etc.) are recorded. Patient response will be determined according to the reduction in pain at follow-up visits at 1, 3, and 6 months after the procedure as follows: good responders will be evaluated as >50% reduction, poor responders will be evaluated as <50% reduction, or no change will be evaluated as non-responders.

Being tested
genicular nerve radiofrequency thermocoagulation and fenole neurolysis
Medical subject headings
Osteoarthritis, Knee

What participants receive

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

  • genicular nerve radiofrequency thermocoagulation and fenole neurolysisProcedure or surgery

    Also called fenole neurolysis

    After visualizing the tibiofemoral joint with fluoroscopy, the potential locations of the geniculate nerves in the medial and lateral regions of the distal femur and medial tibia will be identified with fluoroscopy. A 5 cm long, 5 mm active tip RFT cannula (NeuroThermTM, Medipoint GmbH, Hamburg, Germany) is placed for each geniculate nerve using anteroposterior and lateral fluoroscopy images. Sensory stimulation at 50 Hz and motor stimulation at 2 Hz are then applied, followed by a 2 cc 0.5% bupivacaine block for each geniculate nerve. Each cannula is lesioned for 90 seconds using an 80-degree conventional RFT generator (Neurotherm NT1100 / 13001-12).

    In the phenol neurolysis group, a 22-gauge, 3.5-inch Quincke needle is advanced toward the junction of the femoral shaft and lateral condyle for the superior lateral genicular nerve. A mixture of 6 cc of 0.25% bupivacaine and 6% phenol is injected into each geniculate nerve

Study groups in NCT07381335
Study groupRoleWhat they receive
Group 1Experimentalpatients to whom applied radiofrequency thermocoagulation
Receives: Procedure: genicular nerve radiofrequency thermocoagulation and fenole neurolysis
Group 2Experimentalpatients to whom applied chemical neurolysis
Receives: Procedure: genicular nerve radiofrequency thermocoagulation and fenole neurolysis

What is being measured

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

  1. Efficacy of both methods on knee surgery patients

    Patients undergoing knee arthroplasty surgery for chronic knee osteoarthritis will be evaluated with the Numerical Rating Scale (NRS) before the intervention and at 1, 3, and 6 months after the procedure. A decrease in NRS of 50% or more will be considered significant.

    Measured: 6 months

Secondary outcomes (1)
  1. Safety of both methods on knee surgery patients

    The aim of this study was to determine the side effects and complications of phenol and radiofrequency applications to the geniculate nerve in patients undergoing knee arthroplasty surgery for chronic knee osteoarthritis. Neurological and musculoskeletal examinations will be performed during routine checkups before and at 1, 3, and 6 months after the procedure in patients undergoing knee arthroplasty surgery for chronic knee osteoarthritis, and any developing side effects will be recorded.

    Measured: 12 months

Timeline

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

  1. First posted2 Feb 2026
  2. Study start15 Sep 2025
  3. Primary completionMar 2026 (estimated)
  4. Study completionJun 2026 (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
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07381335
Sponsor's protocol ID
2025/280
Status last verified
Jan 2026
First submitted
20 Jan 2026
Last updated
2 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing genicular nerve radiofrequency thermocoagulation and fenole neurolysis in people with Radiofrequency and Arthroplasty, run by Aydin Adnan Menderes University 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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 2 Feb 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy of both methods on knee surgery patients (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 2 Feb 2026.

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