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).
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.
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.
- Conditions
- Radiofrequency, Arthroplasty, Knee Osteoarthritis
- 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 group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | patients to whom applied radiofrequency thermocoagulation Receives: Procedure: genicular nerve radiofrequency thermocoagulation and fenole neurolysis |
| Group 2 | Experimental | patients 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.
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)
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.
- First posted2 Feb 2026
- Study start15 Sep 2025
- Primary completionMar 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RadiofrequencyStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Ertilav, Aydin Adnan Menderes University
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07381335
- Acronym / sponsor ID
- 2025/280
- Conditions
- Radiofrequency, Arthroplasty, Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 2 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Procedure: genicular nerve radiofrequency thermocoagulation and fenole neurolysispatients to whom applied radiofrequency thermocoagulation |
| Group 2 | Experimental | Procedure: genicular nerve radiofrequency thermocoagulation and fenole neurolysispatients to whom applied chemical neurolysis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Inclusion criteria were patients over the age of 18 who had undergone arthroplasty for chronic knee osteoarthritis.Exclusion Criteria:
Key exclusion criteria (1 listed)
- Patients with severe systemic diseases, local infections or injuries, and those allergic to any of the injection materials were excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| genicular nerve radiofrequency thermocoagulation and fenole neurolysisAlso: fenole neurolysisAfter 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 | Procedure or surgery | Group 1, Group 2 |
Primary outcome
Efficacy of both methods on knee surgery patients
Time frame: 6 months
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.
1 secondary outcome
Safety of both methods on knee surgery patients
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.