Knee Nerve Cryoneurolysis and Impact on Pain After Prosthetic Surgery

NCT05059535 | Terminated Phase 4 DMC

• 1 other identifier: 2021-A01321-40
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 90 ° flexion pain 1 day after the arthroscopy

  1 day

• 90 ° flexion pain 7 days after the arthroscopy

  7 days

• 90 ° flexion pain 30 days after the arthroscopy

  30 days

• 90 ° flexion pain 90 days after the arthroscopy

  90 days

• pain at rest at Day 1

  1 day

Study Arms (3)

cryoneurolysis of the saphenous nerve

EXPERIMENTAL

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

Drug: standard pain relievers

cryoneurolysis of geniculate nerves

EXPERIMENTAL

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

Drug: standard pain relievers

control

PLACEBO COMPARATOR

No cryoneurolysis will be performed before the knee arthroplasty

Drug: standard pain relievers

Interventions

standard pain relievers DRUG

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

Also known as: Standard pain relievers in accordance with the current practice

control; cryoneurolysis of geniculate nerves; cryoneurolysis of the saphenous nerve

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 not beneficiary of a social security scheme.

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead
• Euraxi Pharma: collaborator

Study Sites (1)

Hôpital privé Paul d'Egine

Champigny-sur-Marne, 94500, France

Location

MeSH Terms

Conditions

Knee Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2021
• First Posted: September 28, 2021
• Study Start: January 12, 2022
• Primary Completion: March 10, 2025
• Study Completion: March 10, 2025
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)