Status:
RECRUITING
A Study to Compare Different Ways of Steroid Administration After Total Knee Implantation
Lead Sponsor:
Christian Candrian
Conditions:
Total Knee Replacement
Eligibility:
All Genders
50-85 years
Phase:
PHASE4
Brief Summary
We are going to evaluate the difference between perioperative intravenous steroid supplementation, perioperative periarticular steroid supplementation, and standard anaesthesia protocols. We'll evalua...
Detailed Description
A total of 159 patients will be needed (53 patients per arm, 3 arms in total). Dexamethasone (brand name: Mephameson) is the steroid drug that we perioperative administer in two different ways: intra-...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2033
Estimated Enrollment :
159 Patients enrolled
Trial Details
Trial ID
NCT04432012
Start Date
July 1 2020
End Date
April 30 2033
Last Update
August 6 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Ospedale Regionale di Lugano Civico e Italiano
Lugano, Switzerland, 6900