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

NCT04317872 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2025-04-15

No results posted yet for this study

Summary

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.

Conditions

  • Coxarthrosis
  • Avascular Necrosis of Hip

Interventions

DRUG

High dose of peri-operative intravenous dexamethasone

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

DRUG

Low dose of peri-operative intravenous dexamethasone

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

Sponsors & Collaborators

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Principal Investigators

  • Stijn Ghijselings, MD · Universitaire Ziekenhuizen KU Leuven

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2024-05-03
Completion
2024-05-03

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04317872 on ClinicalTrials.gov