Actively Recruiting
Comparison of Perioperative Intravenous vs Periarticular Dexamethasone vs No Steroid Supplementation for Pain, Function, and Safety in Primary Total Knee Arthroplasty for Knee Osteoarthritis
Led by Christian Candrian · Updated on 2025-08-06
159
Participants Needed
1
Research Sites
365 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients with knee osteoarthritis who are undergoing total knee arthroplasty (TKA) to compare three different steroid administration methods during surgery. This study aims to understand which method—intravenous steroid, intra-articular steroid, or no steroid supplementation—provides better outcomes in terms of pain relief and recovery. It is a randomized, double-blind trial designed to evaluate these approaches over a long period. The study involves three groups of patients receiving different treatments: one group will receive 9 mg of intravenous dexamethasone during surgery, another will receive 9 mg of intra-articular dexamethasone, and the control group will receive the standard anesthesia protocol without steroids. Each group will consist of 53 patients, totaling 159 participants. The interventions are perioperative and occur at the time of surgery. Participants will be followed for up to 10 years with assessments including pain levels at rest in the first 3 days after surgery, knee function, pain intensity, opioid consumption, time to first mobilization, and length of hospital stay. Researchers will also monitor safety by recording steroid-related complications such as infections and hyperglycemia. The study will collect data at multiple points, including up to 10 years post-surgery, with primary data analysis planned after one year of follow-up.
CONDITIONS
Brief Title
A Study to Compare Different Ways of Steroid Administration After Total Knee Implantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients undergoing unilateral primary total knee arthroplasty
- Body mass index (BMI) greater than 18.5 and less than 35
- Able to give informed consent and follow all study procedures
- Signed informed consent form
You will not qualify if you...
- Contraindications to steroids
- Revision total knee arthroplasty
- Currently on active steroid therapy
- Women who are pregnant or breastfeeding
- Other significant diseases classified as ASA IV
- Uncontrolled diabetes mellitus
- Known or suspected drug or alcohol abuse
- Inability to follow study procedures due to language, psychological, or cognitive issues
- Participation in another investigational drug study within 30 days before or during this study
- Previous participation in this study
- Investigator, family members, employees, or dependent persons enrolled
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1 week
Participants undergo total knee arthroplasty and receive either intravenous dexamethasone, intra-articular dexamethasone, or no steroid supplementation as part of their perioperative care.
During hospitalization visits for approximately 3 days
Duration - Up to 6 weeks
Participants are monitored for pain, function, opioid consumption, knee range of motion, inflammatory response, time to mobilization, and patient satisfaction.
Follow-up visits during the first 6 weeks after surgery
Duration - Up to 10 years
Participants are observed for long-term outcomes including pain, knee function, quality of pain, patient satisfaction, and safety measures for up to 10 years after surgery.
Periodic visits as scheduled up to 10 years
Trial Site Locations
Total: 1 location
1
Ospedale Regionale di Lugano Civico e Italiano
Lugano, Switzerland, 6900
Actively Recruiting
Research Team
C
Christian Candrian, MD, Prof
M
Marco Delcogliano, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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