A Study to Compare Different Ways of Steroid Administration After Total Knee Implantation

Launched by CHRISTIAN CANDRIAN · Jun 12, 2020

Keywords

ClinConnect Summary

This clinical trial is looking at different ways to give steroid medications to patients who are having a total knee replacement surgery. The researchers want to find out if giving steroids through an intravenous (IV) line, injecting them around the knee, or using standard anesthesia methods helps improve the recovery and overall experience for patients with knee osteoarthritis.

To participate in this study, you need to be an adult planning to have a total knee replacement at a specific hospital and meet certain health criteria, such as having a body mass index (BMI) between 18.5 and 35. Participants will be asked to follow the study procedures and provide informed consent. If you join the study, you will receive one of the treatment methods and will have the chance to help researchers understand which method is best for patients. It’s important to note that if you are currently on steroids or have other specific health issues, you may not be eligible to participate.

Gender

ALL

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.