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

NCT ID
NCT04432012
Registry status
Recruiting
Study type
Interventional
Phase
Phase 4
Sponsor
Christian Candrian
Conditions
Total Knee Replacement

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: Comparison of Perioperative Intravenous vs Periarticular Dexamethasone vs no Steroid Supplementation in Terms of Post-operative Pain, Function, Nausea, Hospitalization Length, and Risk of Complications in Patients Undergoing Primary Total Knee Arthroplasty for Knee Osteoarthritis - A Randomized Controlled Trial Clinical Study Protocol

Enrollment: 159 participants (Estimated).

What is being studied

  • Intervention: dexamethasone 21-phosphate
  • Drug: Dexamethasone Sodium Phosphate 4 mg/ml intra-articular
  • Drug: Dexamethasone Sodium Phosphate 4 mg/ml intravenous

Who may be eligible

Ages
50 Years to 85 Years
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following 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.

Study locations

1 study location is listed.

Recruiting site status is explicitly provided for 1 location; 1 is listed as Recruiting.

Countries: Switzerland

Sample of listed locations

  • Ospedale Regionale di Lugano Civico e Italiano — Lugano, 6900, Switzerland — Recruiting

Study details

Start date
July 1, 2020
Primary completion date
April 30, 2027
Completion date
April 30, 2033
First posted
June 16, 2020

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT04432012
Registry last updated
September 11, 2026
QualifiedStudies registry data refreshed
October 5, 2026
QualifiedStudies record fetched
October 5, 2026

View NCT04432012 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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