Avascular Necrosis of Hip, Coxarthrosis
Conditions
Keywords
Total Hip Arthroplasty, Direct Anterior Approach, Glucocorticoids, Short term functional outcome
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.
Interventions
DRUGHigh dose of peri-operative intravenous dexamethasone
25mg aacidexam is administered during induction followed by 10mg on the ward after 12 hours
DRUGLow dose of peri-operative intravenous dexamethasone
10mg aacidexam is administered during induction followed by placebo on the ward after 12 hours
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Masking description
An anesthetist or study nurse not involved in further care of the patient nor in the study will prepare the medication to administered based on the allocated group. The first syringe with either 5 or 25 mg of Aacidexam will be administered during induction. The second syringe will go with the patient to the ward and will be administered 12 hours after the surgery by the (blinded) ward nurse. The patient will not be made aware of what has been administered.
Intervention model description
A randomized, single surgeon, placebo controlled, double blind study using two parallel study groups
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Steps | 6 weeks | Number of steps as measured by a pedometer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Fatigue Severity Scale | 6 weeks | Patients Reported Outcome Measures |
Countries
Belgium
Outcome results
None listed