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

RecruitingPhase 4Ages 50 Years - 85 YearsAllChristian Candrian
NCT04432012 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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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What it tests

  • Dexamethasone Sodium Phosphate 4 mg/ml intravenous
  • Dexamethasone Sodium Phosphate 4 mg/ml intra-articular
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Where

1 site
Ospedale Regionale di Lugano Civico e Italiano
Lugano, Switzerland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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