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

Study Overview
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Brief Summary
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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
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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: intervention group: 25 grams of iv dexamethasone at induction followed by 10 mg of iv dexamethasone 12 hours later 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.

Official Title
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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

Conditions
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Coxarthrosis, Avascular Necrosis of Hip

Intervention / Treatment
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* Drug: High dose of peri-operative intravenous dexamethasone
* Drug: Low dose of peri-operative intravenous dexamethasone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomized, single surgeon, placebo controlled, double blind study using two parallel study groups
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Current protocol<br>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. | Drug: High dose of peri-operative intravenous dexamethasone<br>* 25mg aacidexam is administered during induction followed by 10mg on the ward after 12 hours<br>* Other names: Aacidexam;|
| Active Comparator: Old protocol<br>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). | Drug: Low dose of peri-operative intravenous dexamethasone<br>* 10mg aacidexam is administered during induction followed by placebo on the ward after 12 hours<br>* Other names: Aacidexam;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Steps | Number of steps as measured by a pedometer | 6 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total Hip Arthroplasty, Direct Anterior Approach, Glucocorticoids, Short term functional outcome