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

Universitaire Ziekenhuizen KU Leuven

Status: Completed

Conditions: Avascular Necrosis of Hip; Coxarthrosis

Treatments: Drug: High dose of peri-operative intravenous dexamethasone; Drug: Low dose of peri-operative intravenous dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT04317872

S63584

Details and patient eligibility

About

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.

Full 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.

Enrollment: 71 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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71 participants in 2 patient groups

Current protocol

Experimental group

Description:

"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.

Treatment:

Drug: High dose of peri-operative intravenous dexamethasone

Old protocol

Active Comparator group

Description:

"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).

Treatment:

Drug: Low dose of peri-operative intravenous dexamethasone