University Hospitals of Leuven
Leuven, 3000, Belgium
NCT Number: NCT04317872
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Leuven, 3000, Belgium
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:
Based on a power analysis both groups will consist of 35 patients each.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
25mg aacidexam is administered during induction followed by 10mg on the ward after 12 hours
Other names: Aacidexam
10mg aacidexam is administered during induction followed by placebo on the ward after 12 hours
Other names: Aacidexam
Time frame: 6 weeks
Number of steps as measured by a pedometer
Time frame: up to 1 week, 0-10, lower scores indicate better clinical outcome
Post-operative nausea and vomiting Visual Analogue Scale scores
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
Time frame: 6 weeks
Time to achieve certain clinical milestones, e.g. climbing stairs, driving a car, etc
Time frame: 6 weeks
Patients Reported Outcome Measures
Time frame: 6 weeks
Patients Reported Outcome Measures
Time frame: 6 weeks
Patients Reported Outcome Measures
Time frame: 6 weeks
Patients Reported Outcome Measures
Time frame: 6 weeks
Patients Reported Outcome Measures
Time frame: 6 weeks
Patients Reported Outcome Measures
Time frame: 6 weeks
Patients Reported Outcome Measures
Time frame: 6 weeks, 0-10, lower scores indicate better clinical outcome
Visual Analogue Scale scores during the day, the night and during exercises
Time frame: 6 weeks, 0-10, lower scores indicate better clinical outcome
Visual Analogue Scale scores
Time frame: 6 weeks
The use of analgesia such as paracetamol (acetominophen), NSAIDs, and morphine(like) substances
Time frame: Up to 1 week
The use anti-emetics to reduce direct post-operative nausea
Time frame: 6 weeks
The occurrence of complications such as wound healing problems, infections, allergic reactions, venous thrombo-embolisms, etc
Time frame: 6 weeks
The occurrence of side-effects
Universitaire Ziekenhuizen KU Leuven
Other
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
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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