Status:
COMPLETED
Effect of Peri-operative Glucocorticoids on Short-term Functional Outcome After THA
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Coxarthrosis
Avascular Necrosis of Hip
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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-...
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 dexamethaso...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 3 2024
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT04317872
Start Date
July 1 2020
End Date
May 3 2024
Last Update
April 15 2025
Active Locations (1)
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1
University Hospitals of Leuven
Leuven, Belgium, 3000