NCT06094660

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

Patients With Knee Pain Caused by Osteoarthritis: Comparison of Conservative Medical Management With RadioFrequency Ablation or Chemical Neurolysis of the Genicular Nerves With Phenol

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 192 (estimated)
• Sponsor: Dijklander Ziekenhuis · Academic / Other
• Sex: All
• Age: 35 Years – 90 Years
• Healthy volunteers: Not accepted

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).

Detailed description

In guidelines for knee osteoarthritis (OA), conservative treatments are physical therapy, analgesics and intra-articular injections with corticosteroids. In severe OA and persisting symptomatic cases the golden standard is joint replacing surgery. A less invasive technique is ablation of the sensory (genicular) nerves of the knee. This technique is beneficial for younger patients as a bridge to surgery or patients that cannot undergo total knee arthroplasty (TKA) due to comorbid health conditions. Nerve ablation can either be done with chemical agents or thermal energy. Although there are numerous studies on genicular nerve block for chronic knee pain caused by OA, there are just a few small studies that compare genicular nerve block with conservative treatment.To be able to determine if genicular nerve ablation is efficacious to serve the gap between conservative treatment and TKA, this randomised controlled trial (RCT) compares two forms of genicular nerve ablation (radiofrequency and phenolisation; intervention) with conservative treatment (control) up to 6 months after treatment.

Conditions

• Osteo Arthritis Knee
• Knee Pain Chronic

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-11-27
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2023-10-23
• Last updated: 2023-12-05

Locations

2 sites across 1 country: Netherlands