Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:38 PM
Ignite Modification Date:
2025-12-24 @ 10:38 PM
NCT ID:
NCT05059535
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05059535
Study Brief:
Protocol Section:
NCT05059535