Knee Nerve Cryoneurolysis and Impact on Pain After Prosthetic Surgery

Last updated: May 13, 2025
Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Overall Status: Terminated

Phase

4

Condition

Knee Injuries

Treatment

standard pain relievers

Clinical Study ID

NCT05059535
2021-A01321-40
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 theinformation leaflet and agree to sign the consent form.

Exclusion

Exclusion Criteria:

  • Known intolerance to any of the products administered during surgery orcryoneurolysis;

  • 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 ofliberty;

  • Patient participating in another clinical trial, or in a period of exclusion fromanother clinical trial;

  • Patient not beneficiary of a social security scheme.

Study Design

Total Participants: 52
Treatment Group(s): 1
Primary Treatment: standard pain relievers
Phase: 4
Study Start date:
January 12, 2022
Estimated Completion Date:
March 10, 2025

Connect with a study center

  • Hôpital privé Paul d'Egine

    Champigny-sur-marne, 94500
    France

    Site Not Available

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