Knee Nerve Cryoneurolysis and Impact on Pain After Prosthetic Surgery

Knee Injuries Clinical Trial

— Cryogenou  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05059535
• Other study ID #: 2021-A01321-40
• Status: Recruiting
• Phase: Phase 4
• Start date: January 12, 2022
• Est. completion date: October 2025

Study information

• Verified date: November 2023
• Source: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Contact: Mourad MD AÏSSOU
• Phone: +33625650434
• Email: aissou.mourad.sat[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Knee Injuries

Intervention

Drug:
• standard pain relievers
Knee arthroscopy will be performed ansd patients will receive standard pain relievers in confomtity with the current practice

Locations

Country	Name	City	State
France	Hôpital privé Paul d'Egine	Champigny-sur-marne

Sponsors (1)

Lead Sponsor	Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	pain at rest at Day 1	Knee pain after intervention with a visual analogic scale of 100 mm	1 day
Secondary	pain at rest at Day 2	Knee pain after intervention with a visual analogic scale of 100 mm	2 days
Secondary	pain at rest at Day 7	Knee pain after intervention with a visual analogic scale of 100 mm	7 days
Secondary	pain at rest at Day 30	Knee pain after intervention with a visual analogic scale of 100 mm	30 days
Secondary	pain at rest at Day 90	Knee pain after intervention with a visual analogic scale of 100 mm	90 days