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

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universitaire Ziekenhuizen Leuven
• Treatments: BB 1101; Dexamethasone; Dexamethasone acetate; Glucocorticoids

Criteria

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