Cryoneurolysis Versus Bipolar Radiofrequency Ablation of Genicular Nerves for Pain Relief in Symptomatic Knee Osteoarthritis

NCT07855367 | Recruiting

• 1 other identifier: AP2609-501-213
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the reduction in knee pain between ultrasound-guided cryoneurolysis and bipolar radiofrequency ablation (RFA), as measured by the Numerical Rating Scale (NRS) at predefined follow-up intervals.

Conditions

Cryoneurolysis; Bipolar Radiofrequency Ablation; Genicular Nerves; Pain Relief; Symptomatic; Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Degree of pain

  Each patient will be instructed about postoperative pain assessment with the numeric rating scale (NRS) score. NRS (0 represents "no pain" while 10 represents "the worst pain imaginable").

  6 months after procedure

Secondary Outcomes (7)

• Knee Injury and Osteoarthritis Outcome Score

  6 months after procedure

• Western Ontario and McMaster Universities Osteoarthritis Index

  6 months after procedure

• Oxford Knee Score

  6 months after procedure

• Patient Global Impression of Change (PGIC)

  6 months after procedure

• Measurement of quality of life

  6 months after procedure

Study Arms (2)

Cryoneurolysis group

EXPERIMENTAL

Patients will undergo ultrasound-guided cryoneurolysis

Procedure: Ultrasound-guided cryoneurolysis

Radiofrequency ablation group

EXPERIMENTAL

Patients will undergo bipolar radiofrequency ablation

Procedure: Bipolar radiofrequency ablation

Interventions

Ultrasound-guided cryoneurolysis PROCEDURE

Patients will undergo ultrasound-guided cryoneurolysis

Cryoneurolysis group

Bipolar radiofrequency ablation PROCEDURE

Patients will undergo bipolar radiofrequency ablation

Radiofrequency ablation group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 40 years
• Symptomatic knee osteoarthritis (OA) in bladder cancer patient \[based on American College of Radiology (ACR) criteria\]
• Radiological OA (Kellgren-Lawrence grade III-IV)
• Chronic knee pain ≥ 3-6 months
• Numerical Rating Scale (NRS) ≥ 5 despite conservative treatment
• Positive diagnostic genicular nerve block (\>50% pain relief).

You may not qualify if:

• Prior genicular nerve ablation
• Coagulopathy
• Local infection
• Severe deformity
• Neuropathic pain syndromes
• Uncontrolled comorbidities

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

Cairo University

Cairo, 12613, Egypt

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Ahmed S Abdelgalil, MD

CONTACT

00201098426689; ahmed.salah@nci.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anaesthesia and Pain Medicine National Cancer, Cairo University.

Study Record Dates

• First Submitted: September 28, 2026
• First Posted: October 2, 2026
• Study Start: September 15, 2026
• Primary Completion (Estimated): March 15, 2027
• Study Completion (Estimated): March 15, 2027
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)