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

  • STATUS
    Recruiting
  • End date
    Dec 1, 2022
  • participants needed
    70
  • sponsor
    Universitaire Ziekenhuizen Leuven
Updated on 22 July 2021
hip arthroplasty
joint reconstruction

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.

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.

Details
Condition Osteoarthritis of hip, Osteoarthritis, Avascular Necrosis of Hip, hip oa
Treatment High dose of peri-operative intravenous dexamethasone, Low dose of peri-operative intravenous dexamethasone
Clinical Study IdentifierNCT04317872
SponsorUniversitaire Ziekenhuizen Leuven
Last Modified on22 July 2021

Eligibility

Yes No Not Sure

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
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