Knee Nerve Cryoneurolysis and Impact on Pain After Prosthetic Surgery

Study Overview
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Brief Summary
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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.

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

Conditions
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Knee Injuries

Intervention / Treatment
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* Drug: standard pain relievers


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cryoneurolysis of the saphenous nerve<br>A cryoneurolysis of the saphenous nerve will be performed between 7 days and 5 days before the knee arthroplasty | Drug: standard pain relievers<br>* Knee arthroscopy will be performed ansd patients will receive standard pain relievers in confomtity with the current practice<br>* Other names: Standard pain relievers in accordance with the current practice;|
| Experimental: cryoneurolysis of geniculate nerves<br>A cryoneurolysis of geniculate nerves will be performed between 7 days and 5 days before the knee arthroplasty | Drug: standard pain relievers<br>* Knee arthroscopy will be performed ansd patients will receive standard pain relievers in confomtity with the current practice<br>* Other names: Standard pain relievers in accordance with the current practice;|
| Placebo Comparator: control<br>No cryoneurolysis will be performed before the knee arthroplasty | Drug: standard pain relievers<br>* Knee arthroscopy will be performed ansd patients will receive standard pain relievers in confomtity with the current practice<br>* Other names: Standard pain relievers in accordance with the current practice;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| pain at rest at Day 1 | Knee pain after intervention with a visual analogic scale of 100 mm | 1 day | 
| pain at rest at Day 2 | Knee pain after intervention with a visual analogic scale of 100 mm | 2 days | 
| pain at rest at Day 7 | Knee pain after intervention with a visual analogic scale of 100 mm | 7 days | 
| pain at rest at Day 30 | Knee pain after intervention with a visual analogic scale of 100 mm | 30 days | 
| pain at rest at Day 90 | Knee pain after intervention with a visual analogic scale of 100 mm | 90 days |