Knee Injuries
Conditions
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.
Interventions
DRUGstandard pain relievers
Knee arthroscopy will be performed ansd patients will receive standard pain relievers in confomtity with the current practice
Sponsors
Euraxi Pharma
GCS Ramsay Santé pour l'Enseignement et la Recherche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| pain at rest at Day 1 | 1 day | 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 |
| 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 30 | 30 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 |
| pain at rest at Day 2 | 2 days | Knee pain after intervention with a visual analogic scale of 100 mm |
Countries
France
Outcome results
None listed