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:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
NCT ID:
NCT04432012
Eligibility Criteria:
Inclusion Criteria:
* Patients undergoing unilateral primary TKA at the Ospedale Regionale di Lugano.
* Patients with a BMI \>18.5 and \<35.
* Patients able to provide informed consent and follow all the study procedures as indicated by the protocol.
* Informed Consent as documented by signature (Appendix Informed Consent Form).
Exclusion Criteria:
* Contraindications to steroids.
* Revision TKA.
* Active steroid therapy.
* Women who are pregnant or breast feeding.
* Presence of other clinically significant concomitant disease states (ASA IV).
* Uncontrolled diabetes mellitus
* Known or suspected non-compliance, drug or alcohol abuse.
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
* Participation in another study with investigational drug within the 30 days preceding and during the present study.
* Previous enrolment into the current study.
* Enrolment of the investigator, his/her family members, employees and other dependent persons.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
85 Years
Study:
NCT04432012
Study Brief:
Protocol Section:
NCT04432012