Comparing different steroid administration methods after knee replacement surgery
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
Run by Ente Ospedaliero Cantonale, Bellinzona · NCT04432012 · Data updated 2026-11-12
This study is testing whether giving steroids through an IV or directly into the knee helps people recover better after knee replacement surgery compared to not using steroids at all.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 50 Years to 85 Years |
| Sex | All |
| Enrollment | 159 (estimated) |
| Sponsor | Ente Ospedaliero Cantonale, Bellinzona Academic / other |
| Locations | 1 site (Lugano) |
| Status | Recruiting |
| Started | July 1, 2020 |
| Main results expected | April 30, 2027 |
| Study ends | April 30, 2033 |
| Registry record updated | September 11, 2026 |
| Trial ID | NCT04432012 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults undergoing unilateral primary total knee arthroplasty with a BMI between 18.5 and 35.
✕Probably not a fit
Patients with contraindications to steroids, those undergoing revision knee surgeries, or individuals with uncontrolled diabetes may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effects of two methods of steroid administration—intravenous (IV) and intra-articular (IA) dexamethasone—on post-operative outcomes in patients undergoing total knee arthroplasty. A total of 159 patients will be enrolled and divided into three groups: one receiving IV dexamethasone, another receiving IA dexamethasone, and a control group receiving no steroids. The primary focus is to assess post-operative pain, while secondary outcomes include opioid consumption, knee function, and patient satisfaction. The study also aims to evaluate the safety of both steroid administration methods compared to standard care.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management and recovery outcomes for patients undergoing knee replacement surgery.
How similar studies have gone: Previous studies have shown promising results with steroid supplementation in post-operative pain management, suggesting potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Ospedale Regionale di Lugano Civico e Italiano
Lugano, Switzerland Recruiting
Study contacts
- Principal investigator: Christian Candrian, MD, Prof. — Eoc
- Study coordinator: Christian Candrian, MD, Prof
- Email: christian.candrian@eoc.ch
- Phone: +41 (0) 91 811 61 23
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.