NCT04317872

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 dexamethasone at induction followed by 10 mg of iv dexamethasone 12 hours later 2. control group: 5 grams of iv dexamethasone at induction followed by placebo 12 hours later Both patients and surgeons will be blinded. Primary outcome measure will be number of steps during the first 6 weeks as measured by a pedometer. Secondary outcome measures will be side effects, complications, Patient Reported Outcome Measures, pain, nausea, stiffness, achievement of clinical milestones and use of analgesia/anti-emetics. This data will be collected using a tailor made application for a smartphone or tablet and data collecting will start one week before surgery until 6 weeks after surgery. Based on a power analysis both groups will consist of 35 patients each.

Conditions

• Coxarthrosis
• Avascular Necrosis of Hip

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-07-01
• Primary completion: 2024-05-03
• Completion: 2024-05-03
• First posted: 2020-03-23
• Last updated: 2025-04-15

Locations

1 site across 1 country: Belgium