A Study to Compare Different Ways of Steroid Administration After Total Knee Implantation
Recruiting
Phase 4Interventional Study
Total Knee Replacement
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
50 – 85
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
159 (estimated)
Sponsor
Christian Candrian · Other
Who this trial is looking for
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We are going to evaluate the difference between perioperative intravenous steroid supplementation, perioperative periarticular steroid supplementation, and standard anaesthesia protocols. We'll evaluate the outcome of patients with knee osteoarthritis who are undergoing Total Knee Arthroplasty to understand which of the three treatments give more benefits to the patient.
Trial Locations
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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 (A…
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.
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