Knee Nerve Cryoneurolysis and Impact on Pain After Prosthetic Surgery (Cryogenou)

Cryoneurolysis of the Saphenous Nerve or Geniculate Nerves: Impact on Postoperative Pain and Rehabilitation in Prosthetic Knee Surgery

Interventional, comparative, randomized, controlled study versus standard treatment, in 3 parallel groups, monocentric, aiming to demonstrate the superiority of preoperative cryoneurolysis versus no procedure, in patients operated on for knee arthroplasty and receiving standard analgesia.

Study Overview

• Status: Recruiting
• Conditions: Knee Injuries
• Intervention / Treatment: Drug: standard pain relievers

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Mourad MD AÏSSOU; Phone Number: +33625650434; Email: aissou.mourad.sat@gmail.com

Study Locations

• France
  • Champigny-sur-marne, France, 94500
    • Recruiting
    • Hopital Prive Paul d'Egine
    • Contact: Mourad AÏSSOU, MD; Email: aissou.mourad.sat@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 18 years and ≤ 80 years;
• Patient to undergo prosthetic knee surgery;
• Patient in good health (ASA score 1 to 3);
• Patient able to understand the information related to the study, read the information leaflet and agree to sign the consent form.

Exclusion Criteria:

• Known intolerance to any of the products administered during surgery or cryoneurolysis;
• Patient with an electric implant;
• Patient with a contraindication to cryoanalgesia (coagulation disorders, infections, nerve damage);
• Drug addict patient;
• Intervention on septic bone;
• Chronic renal failure (creatinine clearance <30 mL / min);
• History of cryoglobulinemia, cold urticaria or Raynaud's syndrome;
• Pregnant or breastfeeding woman;
• Patient under guardianship or curatorship, or under a regime of deprivation of liberty;
• Patient participating in another clinical trial, or in a period of exclusion from another clinical trial;
• Patient not beneficiary of a social security scheme.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: cryoneurolysis of the saphenous nerve; A cryoneurolysis of the saphenous nerve will be performed between 7 days and 5 days before the knee arthroplasty	Drug: standard pain relievers; Knee arthroscopy will be performed ansd patients will receive standard pain relievers in confomtity with the current practice; Other Names: Standard pain relievers in accordance with the current practice
Experimental: cryoneurolysis of geniculate nerves; A cryoneurolysis of geniculate nerves will be performed between 7 days and 5 days before the knee arthroplasty	Drug: standard pain relievers; Knee arthroscopy will be performed ansd patients will receive standard pain relievers in confomtity with the current practice; Other Names: Standard pain relievers in accordance with the current practice
Placebo Comparator: control; No cryoneurolysis will be performed before the knee arthroplasty	Drug: standard pain relievers; Knee arthroscopy will be performed ansd patients will receive standard pain relievers in confomtity with the current practice; Other Names: Standard pain relievers in accordance with the current practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
90 ° flexion pain 2 days after the arthroscopy	Evaluation of the knee pain at 90° flexion with a visual analogic scale of 100 mm	2 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
90 ° flexion pain 1 day after the arthroscopy	Evaluation of the knee pain at 90° flexion with a visual analogic scale of 100 mm	1 day
90 ° flexion pain 7 days after the arthroscopy	Evaluation of the knee pain at 90° flexion with a visual analogic scale of 100 mm	7 days
90 ° flexion pain 30 days after the arthroscopy	Evaluation of the knee pain at 90° flexion with a visual analogic scale of 100 mm	30 days
90 ° flexion pain 90 days after the arthroscopy	Evaluation of the knee pain at 90° flexion with a visual analogic scale of 100 mm	90 days
pain at rest at Day 1	Knee pain after intervention with a visual analogic scale of 100 mm	1 day
pain at rest at Day 2	Knee pain after intervention with a visual analogic scale of 100 mm	2 days
pain at rest at Day 7	Knee pain after intervention with a visual analogic scale of 100 mm	7 days
pain at rest at Day 30	Knee pain after intervention with a visual analogic scale of 100 mm	30 days
pain at rest at Day 90	Knee pain after intervention with a visual analogic scale of 100 mm	90 days

Collaborators and Investigators

• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2022
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: September 17, 2021
• First Submitted That Met QC Criteria: September 17, 2021
• First Posted (Actual): September 28, 2021

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Acetaminophen; Analgesics
• Other Study ID Numbers: 2021-A01321-40

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No