Effect of Peri-operative Glucocorticoids on Short-term Functional Outcome After THA (DEXA)

April 10, 2025 updated by: Universitaire Ziekenhuizen KU Leuven

Do Peri-operative High Doses of Intravenous Glucocorticoids Improve Short-term Functional Outcome After Direct Anterior Total Hip Arthroplasty? A Randomized, Single Surgeon, Placebo Controlled, Double Blind Study

This randomized, single surgeon, placebo controlled, double blind study will be conducted in order to investigate whether or not peri-operative high doses of intravenous glucocorticoids improve short-term functional outcome after direct anterior total hip arthroplasty. So far, it has been proven that high dose glucocorticoids reduce immediate post-operative pain and nausea, but no data exists on functional outcome during the first 6 weeks. Our hypothesis is that patients in the intervention group will follow a so-called "get ahead, stay ahead" principle and that glucocorticoids can be considered an important tool (adjuvant treatment) in the enhanced recovery pathway after THA with significant socio-economic implications.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients listed for a direct anterior total hip arthroplasty by a single surgeon will be recruited for this study and allocated to one of two groups:

  1. intervention group: 25 grams of iv dexamethasone at induction followed by 10 mg of iv dexamethasone 12 hours later
  2. control group: 5 grams of iv dexamethasone at induction followed by placebo 12 hours later Both patients and surgeons will be blinded. Primary outcome measure will be number of steps during the first 6 weeks as measured by a pedometer. Secondary outcome measures will be side effects, complications, Patient Reported Outcome Measures, pain, nausea, stiffness, achievement of clinical milestones and use of analgesia/anti-emetics. This data will be collected using a tailor made application for a smartphone or tablet and data collecting will start one week before surgery until 6 weeks after surgery.

Based on a power analysis both groups will consist of 35 patients each.

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • University Hospitals of Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • All patients undergoing unilateral uncemented THA for primary OA or AVN of the hip under general anesthesia (GA)
  • Aged 18 years and above (including women of child bearing age)
  • Able to provide informed consent

Exclusion Criteria:

  • Younger than 18 years
  • Known alcohol or drug abuse
  • Known allergy for glucocorticoids
  • Administration of any glucocorticoids in the last three months
  • Usage of strong analgesia (such as lyrica or oxycodone) as regular medication
  • Usage of medication with anticipated interactions with glucocorticoids
  • Known gastric ulcer
  • Insulin dependent diabetes mellitus
  • Severe heart disease (NYHA > 2)
  • Liver or renal failure
  • Systemic rheumatoid diseases
  • Insufficient understanding of the Dutch language
  • Unable to provide informed consent
  • Pre-operative use of walking aids
  • Gross anatomical deformities
  • Significant intra-operative complications such as periprosthetic fracture

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Current protocol
"Current protocol": patients will receive a single shot of 25mg of aacidexam iv (5cc) at induction. After 12 hours these patients will another shot of 10mg of aacidexam iv (2cc) on the ward.
Drug: High dose of peri-operative intravenous dexamethasone
25mg aacidexam is administered during induction followed by 10mg on the ward after 12 hours
Other Names:
  • Aacidexam
Active Comparator: Old protocol
"Old protocol": patients will receive a single shot of 5mg of aacidexam iv at induction (5cc). After arrival 12 hours these patients will receive a placebo, i.e. a shot of 2 cc of NaCl 0.9% iv (Mini-Plasco van B. Braun).
Drug: Low dose of peri-operative intravenous dexamethasone
10mg aacidexam is administered during induction followed by placebo on the ward after 12 hours
Other Names:
  • Aacidexam

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Steps
Time Frame: 6 weeks
Number of steps as measured by a pedometer
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative nausea and vomiting
Time Frame: up to 1 week, 0-10, lower scores indicate better clinical outcome
Post-operative nausea and vomiting Visual Analogue Scale scores
up to 1 week, 0-10, lower scores indicate better clinical outcome
Same day mobilization
Time Frame: 1 day (yes or no)
Whether or not if was possible for the physiotherapists to mobilize the patient on the day of surgery
1 day (yes or no)
Clinical milestones
Time Frame: 6 weeks
Time to achieve certain clinical milestones, e.g. climbing stairs, driving a car, etc
6 weeks
Oxford Hip Score
Time Frame: 6 weeks
Patients Reported Outcome Measures
6 weeks
Western Ontario and McMaster Universities Osteoarthritis Index
Time Frame: 6 weeks
Patients Reported Outcome Measures
6 weeks
Hip dysfunction and Osteoarthritis Outcome Score
Time Frame: 6 weeks
Patients Reported Outcome Measures
6 weeks
Forgotten Joint Score
Time Frame: 6 weeks
Patients Reported Outcome Measures
6 weeks
Short Form 36
Time Frame: 6 weeks
Patients Reported Outcome Measures
6 weeks
Fatigue Severity Scale
Time Frame: 6 weeks
Patients Reported Outcome Measures
6 weeks
Groningen Activity Restriction Scale
Time Frame: 6 weeks
Patients Reported Outcome Measures
6 weeks
Pain scores
Time Frame: 6 weeks, 0-10, lower scores indicate better clinical outcome
Visual Analogue Scale scores during the day, the night and during exercises
6 weeks, 0-10, lower scores indicate better clinical outcome
Stiffness
Time Frame: 6 weeks, 0-10, lower scores indicate better clinical outcome
Visual Analogue Scale scores
6 weeks, 0-10, lower scores indicate better clinical outcome
Use of Analgesia
Time Frame: 6 weeks
The use of analgesia such as paracetamol (acetominophen), NSAIDs, and morphine(like) substances
6 weeks
Use of Anti-emetics
Time Frame: Up to 1 week
The use anti-emetics to reduce direct post-operative nausea
Up to 1 week
Complications
Time Frame: 6 weeks
The occurrence of complications such as wound healing problems, infections, allergic reactions, venous thrombo-embolisms, etc
6 weeks
Side effects
Time Frame: 6 weeks
The occurrence of side-effects
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Investigators

  • Principal Investigator: Stijn Ghijselings, MD, Universitaire Ziekenhuizen KU Leuven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2020

Primary Completion (Actual)

May 3, 2024

Study Completion (Actual)

May 3, 2024

Study Registration Dates

First Submitted

March 17, 2020

First Submitted That Met QC Criteria

March 19, 2020

First Posted (Actual)

March 23, 2020

Study Record Updates

Last Update Posted (Actual)

April 15, 2025

Last Update Submitted That Met QC Criteria

April 10, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S63584

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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