Actively Recruiting

Phase 4
Age: 50Years - 85Years
All Genders
ID04432012

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

Age: 50Years - 85Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

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

Post-operative Follow-up

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

Long-term Monitoring

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

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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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