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

Universitaire Ziekenhuizen KU Leuven71 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Steps

Number of steps as measured by a pedometer

Time frame: 6 weeks

Secondary Outcomes

Post-operative nausea and vomiting

Post-operative nausea and vomiting Visual Analogue Scale scores

Time frame: 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

Time frame: 1 day (yes or no)

Clinical milestones

Time to achieve certain clinical milestones, e.g. climbing stairs, driving a car, etc

Time frame: 6 weeks

Oxford Hip Score