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RFA or Chemical Neurolysis of the Genicular Nerves Compared to Conservative Treatment for Knee Pain Caused by OA

NCT06094660 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2023-12-05

No results posted yet for this study

Summary

A randomised controlled triall (RCT) with three parallel arms comparing the functional outcome of chemical ablation with phenol and radiofrequency ablation (RFA) of the genicular nerves with conservative treatment in patients with chronic knee pain caused by osteoarthritis (OA).

Conditions

  • Osteo Arthritis Knee
  • Knee Pain Chronic

Interventions

PROCEDURE

Diagnostic genicular nerve block

Diagnostic block will be done with 1,5ml of Lidocaine 2% at the 3 target sites: the superomedial, the superolateral and the inferomedial genicular nerve.

PROCEDURE

Genicular nerve block with Radiofrequency Ablation (RFA)

Genicular nerve block with RFA will be performed at 3 target sites: the superomedial, the superolateral and the inferomedial genicular nerve. Radiofrequency ablation (RFA) is performed by creating two RFA lesions at the 3 treatment sites (6 lesions in total) after local anesthesia with 1,5ml lidocaine 2%. The lesions are made by heating the 5mm active tip of the needle to 80°C for 90 seconds.

PROCEDURE

Genicular nerve block with Phenol 6%

Genicular nerve block with Phenol 6% will be performed at 3 target sites: the superomedial, the superolateral and the inferomedial genicular nerve. Chemical ablation with phenol is done by injection of 1 ,5ml of phenol 6 % at the 3 target sites after infiltration with contrast dye to rule out intravascular injection. Because infiltration with phenol is painless, prior infiltration of the target site with al local anaesthetic is not necessary.

Sponsors & Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    collaborator OTHER

  • Bravis Hospital

    collaborator OTHER

  • Dijklander Ziekenhuis

    lead OTHER

Principal Investigators

  • Gezina Oei, MD, PhD · Academic Medical Centre Amsterdam

  • Markus Hollmann, Prof · Academic Medical Centre Amsterdam

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-27
Primary Completion
2026-11-01
Completion
2026-11-01

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06094660 on ClinicalTrials.gov