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Completed

NCT Number: NCT04317872

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals of Leuven

Leuven, 3000, Belgium

About this study

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:

  • intervention group: 25 grams of iv dexamethasone at induction followed by 10 mg of iv dexamethasone 12 hours later
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High dose of peri-operative intravenous dexamethasone

Drug

25mg aacidexam is administered during induction followed by 10mg on the ward after 12 hours

Other names: Aacidexam

Low dose of peri-operative intravenous dexamethasone

Drug

10mg aacidexam is administered during induction followed by placebo on the ward after 12 hours

Other names: Aacidexam

Primary outcomes

  1. Steps

    Time frame: 6 weeks

    Number of steps as measured by a pedometer

Secondary outcomes

  1. 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

  2. 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

  3. Clinical milestones

    Time frame: 6 weeks

    Time to achieve certain clinical milestones, e.g. climbing stairs, driving a car, etc

  4. Oxford Hip Score

    Time frame: 6 weeks

    Patients Reported Outcome Measures

  5. Western Ontario and McMaster Universities Osteoarthritis Index

    Time frame: 6 weeks

    Patients Reported Outcome Measures

  6. Hip dysfunction and Osteoarthritis Outcome Score

    Time frame: 6 weeks

    Patients Reported Outcome Measures

  7. Forgotten Joint Score

    Time frame: 6 weeks

    Patients Reported Outcome Measures

  8. Short Form 36

    Time frame: 6 weeks

    Patients Reported Outcome Measures

  9. Fatigue Severity Scale

    Time frame: 6 weeks

    Patients Reported Outcome Measures

  10. Groningen Activity Restriction Scale

    Time frame: 6 weeks

    Patients Reported Outcome Measures

  11. 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

  12. Stiffness

    Time frame: 6 weeks, 0-10, lower scores indicate better clinical outcome

    Visual Analogue Scale scores

  13. Use of Analgesia

    Time frame: 6 weeks

    The use of analgesia such as paracetamol (acetominophen), NSAIDs, and morphine(like) substances

  14. Use of Anti-emetics

    Time frame: Up to 1 week

    The use anti-emetics to reduce direct post-operative nausea

  15. Complications

    Time frame: 6 weeks

    The occurrence of complications such as wound healing problems, infections, allergic reactions, venous thrombo-embolisms, etc

  16. Side effects

    Time frame: 6 weeks

    The occurrence of side-effects

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Acronym: DEXA

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Mar 23, 2020
Registry last updated
Apr 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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