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

Not Applicable

Completed

• Conditions: Coxarthrosis; Avascular Necrosis of Hip
• Interventions: Drug: Low dose of peri-operative intravenous dexamethasone; Drug: High dose of peri-operative intravenous dexamethasone

• Registration Number: NCT04317872
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief 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.

Study Timeline

• Study First Submitted: 2020-03-17
• Study First Submitted QC: 2020-03-19
• Study First Posted: 2020-03-23
• Study Start: 2020-07-01
• Primary Completion: 2024-05-03
• Study Completion: 2024-05-03
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Old protocol	Low dose of peri-operative intravenous dexamethasone	"Old protocol": patients will receive a single shot of 5mg of aacidexam iv at induction (5cc). After arrival 12 hours these patients will receive a placebo, i.e. a shot of 2 cc of NaCl 0.9% iv (Mini-Plasco van B. Braun).
Current protocol	High dose of peri-operative intravenous dexamethasone	"Current protocol": patients will receive a single shot of 25mg of aacidexam iv (5cc) at induction. After 12 hours these patients will another shot of 10mg of aacidexam iv (2cc) on the ward.

Primary Outcome Measures

Name	Time	Method
Steps	6 weeks	Number of steps as measured by a pedometer

Secondary Outcome Measures

Name	Time	Method
Post-operative nausea and vomiting	up to 1 week, 0-10, lower scores indicate better clinical outcome	Post-operative nausea and vomiting Visual Analogue Scale scores
Same day mobilization	1 day (yes or no)	Whether or not if was possible for the physiotherapists to mobilize the patient on the day of surgery
Clinical milestones	6 weeks	Time to achieve certain clinical milestones, e.g. climbing stairs, driving a car, etc
Oxford Hip Score	6 weeks	Patients Reported Outcome Measures
Western Ontario and McMaster Universities Osteoarthritis Index	6 weeks	Patients Reported Outcome Measures
Hip dysfunction and Osteoarthritis Outcome Score	6 weeks	Patients Reported Outcome Measures
Forgotten Joint Score	6 weeks	Patients Reported Outcome Measures
Short Form 36	6 weeks	Patients Reported Outcome Measures
Fatigue Severity Scale	6 weeks	Patients Reported Outcome Measures
Groningen Activity Restriction Scale	6 weeks	Patients Reported Outcome Measures
Pain scores	6 weeks, 0-10, lower scores indicate better clinical outcome	Visual Analogue Scale scores during the day, the night and during exercises
Stiffness	6 weeks, 0-10, lower scores indicate better clinical outcome	Visual Analogue Scale scores
Use of Analgesia	6 weeks	The use of analgesia such as paracetamol (acetominophen), NSAIDs, and morphine(like) substances
Use of Anti-emetics	Up to 1 week	The use anti-emetics to reduce direct post-operative nausea
Complications	6 weeks	The occurrence of complications such as wound healing problems, infections, allergic reactions, venous thrombo-embolisms, etc
Side effects	6 weeks	The occurrence of side-effects

Trial Locations

Locations (1)

University Hospitals of Leuven; 🇧🇪 Leuven, Belgium