Clinical trial
Cryoneurolysis of the Saphenous Nerve or Geniculate Nerves: Impact on Postoperative Pain and Rehabilitation in Prosthetic Knee Surgery
Name
2021-A01321-40
Description
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.
Trial arms
Trial start
2022-01-12
Estimated PCD
2025-10-01
Trial end
2025-10-01
Status
Recruiting
Phase
Early phase I
Treatment
standard pain relievers
Knee arthroscopy will be performed ansd patients will receive standard pain relievers in confomtity with the current practice
Arms:
control, cryoneurolysis of geniculate nerves, cryoneurolysis of the saphenous nerve
Other names:
Standard pain relievers in accordance with the current practice
Size
90
Primary endpoint
90 ° flexion pain 2 days after the arthroscopy
2 days
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 90, 'type': 'ESTIMATED'}}
Updated at
2023-11-18
1 organization
1 product
1 indication
Product
Standard pain relieversIndication
Knee Injuries