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

Coxarthrosis Clinical Trial

Official title: 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 Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Avascular Necrosis of Hip
• Coxarthrosis
• Necrosis
• Osteoarthritis, Hip

• NCT number: NCT04317872
• Study type: Interventional
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: Stijn Ghijselings, MD
• Phone: +320472576735
• Email: stijn.ghijselings@uzleuven.be
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2020
• Completion date: December 1, 2024