Cryoneurolysis Prior to Total Knee Arthroplasty

NARecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

August 30, 2023

Primary Completion Date

December 1, 2024

Study Completion Date

August 1, 2025

Conditions
Post Operative PainKnee OsteoarthritisOpioid-Related Disorders
Interventions
DEVICE

Cryoneurolysis

The VISUAL-ICE uses a combination of argon and helium, to create a highly localized cold zone with temperatures between -20 and -100°C. A probe will be inserted percutaneously at the target AFCN and IBSN guided by ultrasound visualization to accurately determine the location of the nerve and to account for adjacent neurovascular structures and variations in anatomical structures. The target locations are drawn directly on the patients' skin prior to treatment along which a dose of local anesthetic will be injected subcutaneously before treatment. Cryoneurolysis at each target site requires 2 freeze cycles with a duration of 3 mins, and with thaw cycles between 20-40 seconds.

OTHER

Sham

A sham needles will be inserted percutaneously at the target AFCN and IBSN guided by ultrasound visualization. The target locations are drawn directly on the patients' skin prior to treatment along which a dose of local anesthetic will be injected subcutaneously before treatment. Sham will simulate cryoneurolysis at each target site for 2 freeze cycles with a duration of 3 mins, and also simulate thaw cycles between 20-40 seconds. No temperature changes will actually occur although the experience and sounds will be similar to cryoneurolysis

Trial Locations (1)

6700

RECRUITING

Hospital of Southwest Jutland, Esbjerg

Sponsors
All Listed Sponsors
collaborator

Odense University Hospital

OTHER

collaborator

Boston Scientific Corporation

INDUSTRY

lead

Esbjerg Hospital - University Hospital of Southern Denmark

OTHER

NCT05840276 - Cryoneurolysis Prior to Total Knee Arthroplasty | Biotech Hunter | Biotech Hunter