Phenol Neurolysis and Radiofrequency Thermocoagulation in Knee Arthroplasty Surgery

NCT07381335 | Active Not Recruiting DMC

• 1 other identifier: 2025/280
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Arthroplasty; Knee Osteoarthritis; Radiofrequency

Outcome Measures

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.

  6 months

Secondary Outcomes (1)

• Safety of both methods on knee surgery patients

  12 months

Study Arms (2)

Group 1

EXPERIMENTAL

patients to whom applied radiofrequency thermocoagulation

Procedure: genicular nerve radiofrequency thermocoagulation and fenole neurolysis

Group 2

EXPERIMENTAL

patients to whom applied chemical neurolysis

Procedure: genicular nerve radiofrequency thermocoagulation and fenole neurolysis

Interventions

genicular nerve radiofrequency thermocoagulation and fenole neurolysis PROCEDURE

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

Group 1; Group 2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

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

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Esra Ertilav

Aydin, Efeler/Aydın, 09100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc.Prof.

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: February 2, 2026
• Study Start: September 15, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)