Back to resultsKnee Nerve Cryoneurolysis and Impact on Pain After Prosthetic Surgery (Cryogenou)
Primary Purpose
Knee Injuries
Status
Recruiting
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
standard pain relievers
Sponsored by
About this trial
This is an interventional prevention trial for Knee Injuries
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.
Sites / Locations
- Hôpital privé Paul d'EgineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
cryoneurolysis of the saphenous nerve
cryoneurolysis of geniculate nerves
control
Arm Description
A cryoneurolysis of the saphenous nerve will be performed between 7 days and 5 days before the knee arthroplasty
A cryoneurolysis of geniculate nerves will be performed between 7 days and 5 days before the knee arthroplasty
No cryoneurolysis will be performed before the knee arthroplasty
Outcomes
Primary Outcome Measures
90 ° flexion pain 2 days after the arthroscopy
Evaluation of the knee pain at 90° flexion with a visual analogic scale of 100 mm
Secondary Outcome Measures
90 ° flexion pain 1 day after the arthroscopy
Evaluation of the knee pain at 90° flexion with a visual analogic scale of 100 mm
90 ° flexion pain 7 days after the arthroscopy
Evaluation of the knee pain at 90° flexion with a visual analogic scale of 100 mm
90 ° flexion pain 30 days after the arthroscopy
Evaluation of the knee pain at 90° flexion with a visual analogic scale of 100 mm
90 ° flexion pain 90 days after the arthroscopy
Evaluation of the knee pain at 90° flexion with a visual analogic scale of 100 mm
pain at rest at Day 1
Knee pain after intervention with a visual analogic scale of 100 mm
pain at rest at Day 2
Knee pain after intervention with a visual analogic scale of 100 mm
pain at rest at Day 7
Knee pain after intervention with a visual analogic scale of 100 mm
pain at rest at Day 30
Knee pain after intervention with a visual analogic scale of 100 mm
pain at rest at Day 90
Knee pain after intervention with a visual analogic scale of 100 mm
Full Information
NCT ID
NCT05059535
First Posted
September 17, 2021
Last Updated
April 26, 2022
Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
1. Study Identification
Unique Protocol Identification Number
NCT05059535
Brief Title
Knee Nerve Cryoneurolysis and Impact on Pain After Prosthetic Surgery
Acronym
Cryogenou
Official Title
Cryoneurolysis of the Saphenous Nerve or Geniculate Nerves: Impact on Postoperative Pain and Rehabilitation in Prosthetic Knee Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 12, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Injuries
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
cryoneurolysis of the saphenous nerve
Arm Type
Experimental
Arm Description
A cryoneurolysis of the saphenous nerve will be performed between 7 days and 5 days before the knee arthroplasty
Arm Title
cryoneurolysis of geniculate nerves
Arm Type
Experimental
Arm Description
A cryoneurolysis of geniculate nerves will be performed between 7 days and 5 days before the knee arthroplasty
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
No cryoneurolysis will be performed before the knee arthroplasty
Intervention Type
Drug
Intervention Name(s)
standard pain relievers
Other Intervention Name(s)
Standard pain relievers in accordance with the current practice
Intervention Description
Knee arthroscopy will be performed ansd patients will receive standard pain relievers in confomtity with the current practice
Primary Outcome Measure Information:
Title
90 ° flexion pain 2 days after the arthroscopy
Description
Evaluation of the knee pain at 90° flexion with a visual analogic scale of 100 mm
Time Frame
2 days
Secondary Outcome Measure Information:
Title
90 ° flexion pain 1 day after the arthroscopy
Description
Evaluation of the knee pain at 90° flexion with a visual analogic scale of 100 mm
Time Frame
1 day
Title
90 ° flexion pain 7 days after the arthroscopy
Description
Evaluation of the knee pain at 90° flexion with a visual analogic scale of 100 mm
Time Frame
7 days
Title
90 ° flexion pain 30 days after the arthroscopy
Description
Evaluation of the knee pain at 90° flexion with a visual analogic scale of 100 mm
Time Frame
30 days
Title
90 ° flexion pain 90 days after the arthroscopy
Description
Evaluation of the knee pain at 90° flexion with a visual analogic scale of 100 mm
Time Frame
90 days
Title
pain at rest at Day 1
Description
Knee pain after intervention with a visual analogic scale of 100 mm
Time Frame
1 day
Title
pain at rest at Day 2
Description
Knee pain after intervention with a visual analogic scale of 100 mm
Time Frame
2 days
Title
pain at rest at Day 7
Description
Knee pain after intervention with a visual analogic scale of 100 mm
Time Frame
7 days
Title
pain at rest at Day 30
Description
Knee pain after intervention with a visual analogic scale of 100 mm
Time Frame
30 days
Title
pain at rest at Day 90
Description
Knee pain after intervention with a visual analogic scale of 100 mm
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mourad MD AÏSSOU
Phone
+33625650434
Email
aissou.mourad.sat@gmail.com
Facility Information:
Facility Name
Hôpital privé Paul d'Egine
City
Champigny-sur-marne
ZIP/Postal Code
94500
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mourad AÏSSOU, MD
Email
aissou.mourad.sat@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Knee Nerve Cryoneurolysis and Impact on Pain After Prosthetic Surgery
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