RecruitingPhase 4NCT04432012

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

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


Sponsor

Christian Candrian

Enrollment

159 participants

Start Date

Jul 1, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 50 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing different ways of giving steroid medication to patients after total knee replacement surgery (TKA). Steroids are powerful anti-inflammatory drugs that can help reduce pain and swelling after surgery, but the best way to administer them — by injection into the joint, intravenously, or another route — is not yet clear. The goal is to find out which method provides the best pain control with the fewest side effects. Patients are randomly assigned to one of the administration methods and followed closely after surgery to measure pain levels, swelling, need for additional pain medications, and any complications. Better pain management after knee replacement means faster recovery and better patient outcomes. You may be eligible if: - You are between 50 and 85 years old - You are having a first-time (primary) total knee replacement at the study hospital - You have a BMI between 18.5 and 35 - You are able to give informed consent and follow all study procedures You may NOT be eligible if: - You have a contraindication to steroids - You are having a revision (repeat) knee replacement - You are already on steroid therapy - You are pregnant or breastfeeding - You have uncontrolled diabetes - You have serious other health conditions (ASA class IV) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDexamethasone Sodium Phosphate 4 mg/ml intravenous

Perioperative intravenous injection of 3 ml of solution (9mg of dexamethasone)

DRUGDexamethasone Sodium Phosphate 4 mg/ml intra-articular

Perioperative intra-articular injection of 3 ml of solution (9mg of dexamethasone)


Locations(1)

Ospedale Regionale di Lugano Civico e Italiano

Lugano, Switzerland

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NCT04432012


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