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Active, not recruitingNCT07381335Updated Feb 2, 2026

Phenol Neurolysis and Radiofrequency Thermocoagulation in Knee Arthroplasty Surgery

An interventional study of genicular nerve radiofrequency thermocoagulation and fenole neurolysis in Radiofrequency, Arthroplasty and Knee Osteoarthritis, sponsored by Aydin Adnan Menderes University. Active, not recruiting at 1 site in Turkey (Türkiye). Per ClinicalTrials.gov, last updated 2026-02-02.

Sponsored by Aydin Adnan Menderes University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Mar 2026, 7 months ago, but the record still lists the study as active, not recruiting.
  • Registered 4 months after the study started (first participant enrolled Sep 2025, registered Jan 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
140
Allocation
Randomized
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Radiofrequency
  • Arthroplasty
  • Knee Osteoarthritis
03

In context

Osteoarthritis, Knee

3,302 studies on the registry are indexed under Osteoarthritis, Knee; 608 are open to participants now.

This study's planned enrollment of 140 is above the median of 70 across 2,731 interventional studies indexed under Osteoarthritis, Knee.

Browse Osteoarthritis, Knee studies →

Lead sponsor

Aydin Adnan Menderes University is the lead sponsor of 236 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
140 participants (estimated)

Study arms

  • Experimental
    Group 1

    patients to whom applied radiofrequency thermocoagulation

    Procedure: genicular nerve radiofrequency thermocoagulation and fenole neurolysis

  • Experimental
    Group 2

    patients to whom applied chemical neurolysis

    Procedure: genicular nerve radiofrequency thermocoagulation and fenole neurolysis

Interventions

  • Proceduregenicular nerve radiofrequency thermocoagulation and 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

    Also known as: fenole neurolysis

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

    Time frame: 12 months

07

Study locations

1 site
  • Esra Ertilav
    Aydin, Efeler/Aydın 09100, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07381335
Lead sponsor
Aydin Adnan Menderes University
Responsible party
Esra Ertilav (Assoc.Prof., Aydin Adnan Menderes University) — Principal investigator
First posted
Feb 2, 2026
Start date
Sep 15, 2025
Primary completion
Mar 2026 (estimated)
Completion
Jun 2026 (estimated)
Last update
Feb 2, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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