Knee Nerve Cryoneurolysis and Impact on Pain After Prosthetic Surgery

NCT ID: NCT05059535

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-12
• Study Completion Date: 2025-03-10

Brief 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.

Conditions

Knee Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

cryoneurolysis of the saphenous nerve

A cryoneurolysis of the saphenous nerve will be performed between 7 days and 5 days before the knee arthroplasty

Group Type: EXPERIMENTAL

standard pain relievers

Intervention Type: DRUG

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

cryoneurolysis of geniculate nerves

A cryoneurolysis of geniculate nerves will be performed between 7 days and 5 days before the knee arthroplasty

Group Type: EXPERIMENTAL

standard pain relievers

Intervention Type: DRUG

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

control

No cryoneurolysis will be performed before the knee arthroplasty

Group Type: PLACEBO_COMPARATOR

standard pain relievers

Intervention Type: DRUG

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

Interventions

standard pain relievers

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

Intervention Type: DRUG

Other Intervention Names

Standard pain relievers in accordance with the current practice

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Euraxi Pharma

INDUSTRY

Sponsor Role: collaborator

GCS Ramsay Santé pour l'Enseignement et la Recherche

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital privé Paul d'Egine

Champigny-sur-Marne, , France

Countries

France

Other Identifiers

2021-A01321-40

Identifier Type: -

Identifier Source: org_study_id