Effect of Peri-operative Glucocorticoids on Short-term Functional Outcome After THA (NCT04317872) | Clinical Trial Compass
CompletedNot Applicable
Effect of Peri-operative Glucocorticoids on Short-term Functional Outcome After THA
Belgium71 participantsStarted 2020-07-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.