Knee Nerve Cryoneurolysis and Impact on Pain After Prosthetic Surgery

Phase 4

Terminated

• Conditions: Knee Injuries
• Interventions: Drug: standard pain relievers

• Registration Number: NCT05059535
• Lead Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-17
• Study First Submitted QC: 2021-09-17
• Study First Posted: 2021-09-28
• Study Start: 2022-01-12
• Primary Completion: 2025-03-10
• Study Completion: 2025-03-10
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 52

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cryoneurolysis of the saphenous nerve	standard pain relievers	A cryoneurolysis of the saphenous nerve will be performed between 7 days and 5 days before the knee arthroplasty
control	standard pain relievers	No cryoneurolysis will be performed before the knee arthroplasty
cryoneurolysis of geniculate nerves	standard pain relievers	A cryoneurolysis of geniculate nerves will be performed between 7 days and 5 days before the knee arthroplasty

Primary Outcome Measures

Name	Time	Method
90 ° flexion pain 2 days after the arthroscopy	2 days	Evaluation of the knee pain at 90° flexion with a visual analogic scale of 100 mm

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hôpital privé Paul d'Egine; 🇫🇷 Champigny-sur-marne, France