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

Phase 1

Conditions: Functional recovary after total hip arthroplasty
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2019-004834-40-BE

Lead Sponsor: niversity Hospitals Leuven

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 70

Inclusion Criteria

- All patients undergoing unilateral uncemented THA for primary OA of AVN of the hip under general anesthesia (GA)
- Aged 18 years and above (including women of child bearing age)
- Able to provide informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

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, 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 complication such as peri-prosthetic fracture

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Determine whether peri-operative intravenous glucocorticoids aid in the recovery after THA.;Secondary Objective: Post-operative nausea and vomiting (PONV)<br>Same day mobilization<br>Time to ability to do stairs<br>Time to driving a car<br>Patient questionnaires: Oxford Hip Score; WOMAC; HOOS; Forgotten Joint Score; SF-36; Fatigue Severity scale; VAS pain day / night / exercises; VAS stiffness <br>Use of analgesia<br>Use of anti-emetics <br>Complications: wound healing problems; Infections; allergic reactions; venous Trombo-embolisms (VTE); side effects<br>;Primary end point(s): Average number of steps ;Timepoint(s) of evaluation of this end point: Average number of steps per day during one week before total hip arthroplastyand the first 6 weeks after total hip arthroplasty

Secondary Outcome Measures