Clinical trial NCT04317872: Effect of Peri-operative Glucocorticoids on Short-term Functional Outcome After THA
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coxarthrosis
Avascular Necrosis of Hip
Keywords: Total Hip Arthroplasty
Direct Anterior Approach
Glucocorticoids
Short term functional outcome
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2020-03-23
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized, single surgeon, placebo controlled, double blind study using two parallel study groups
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Steps
timeFrame: 6 weeks
Secondary outcomes:
measure: Post-operative nausea and vomiting
timeFrame: up to 1 week, 0-10, lower scores indicate better clinical outcome
measure: Same day mobilization
timeFrame: 1 day (yes or no)
measure: Clinical milestones
timeFrame: 6 weeks
measure: Oxford Hip Score
timeFrame: 6 weeks
measure: Western Ontario and McMaster Universities Osteoarthritis Index
timeFrame: 6 weeks
measure: Hip dysfunction and Osteoarthritis Outcome Score
timeFrame: 6 weeks
measure: Forgotten Joint Score
timeFrame: 6 weeks
measure: Short Form 36
timeFrame: 6 weeks
measure: Fatigue Severity Scale
timeFrame: 6 weeks
measure: Groningen Activity Restriction Scale
timeFrame: 6 weeks
measure: Pain scores
timeFrame: 6 weeks, 0-10, lower scores indicate better clinical outcome
measure: Stiffness
timeFrame: 6 weeks, 0-10, lower scores indicate better clinical outcome
measure: Use of Analgesia
timeFrame: 6 weeks
measure: Use of Anti-emetics
timeFrame: Up to 1 week
measure: Complications
timeFrame: 6 weeks
measure: Side effects
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals of Leuven
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Stijn Ghijselings, MD
role: PRINCIPAL_INVESTIGATOR
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