How dexamethasone dose affects recovery and quality of life after total hip replacement
The Effect of Corticosteroids on Quality of Life Following Total Hip Arthroplasty: HIPSTER Study
This trial will test whether a single low (5 mg) or higher (25 mg) dose of dexamethasone given during surgery helps people aged 60 and older recover faster and have better quality of life in the three months after total hip replacement.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 224 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Ziekenhuis Oost-Limburg Academic / other |
| Locations | 2 sites (Genk, Limburg and 1 other locations) |
| Trial ID | NCT07378215 on ClinicalTrials.gov |
What this trial studies
The HIPSTER trial compares a single intraoperative IV dose of dexamethasone 5 mg versus 25 mg in older adults undergoing elective total hip arthroplasty under spinal anaesthesia. Participants receive one of the two doses during surgery and are followed for health-related quality of life and persistent pain up to three months postoperatively. The study builds on ERAS practices that use corticosteroids to reduce acute postoperative pain, nausea and fatigue, while specifically measuring longer-term patient-reported outcomes. Enrollment and follow-up take place at Ziekenhuis Oost-Limburg with standard perioperative care otherwise unchanged.
Who should consider this trial
Good fit: Ideal candidates are patients aged 60 or older scheduled for elective total hip arthroplasty under spinal anaesthesia who can give informed consent and are not on chronic systemic corticosteroids.
Not a fit: Patients who may not benefit include those having revision or bilateral hip replacements, those on chronic systemic steroids, people with steroid hypersensitivity or active gastrointestinal ulcers, and patients requiring urgent or non-elective surgery.
Why it matters
Potential benefit: If successful, finding the optimal dexamethasone dose could improve postoperative pain, fatigue, nausea and overall quality of life after hip replacement.
How similar studies have performed: Previous studies show single perioperative dexamethasone doses reduce short-term pain, nausea and fatigue after orthopedic surgery, but evidence on effects on quality of life beyond the immediate postoperative period is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * aged 60 years or older; * scheduled for elective total hip arthroplasty; * procedure under spinal anaesthesia. Exclusion Criteria: * hip revision surgery (reoperation); * bilateral total hip arthroplasty during the same procedure; * known hypersensitivity to dexamethasone or other corticosteroids; * chronic systemic use of corticosteroids, defined as daily corticosteroid therapy for \> 4 weeks within the last 3 months, with anticipated need for a perioperative stress dose of corticosteroids; * active gastric of intestinal ulcers; * lack of informed consent or inability to give informed consent; * urgent, non-elective surgery.
Where this trial is running
Genk, Limburg and 1 other locations
- Ziekenhuis Oost-Limburg — Genk, Limburg, Belgium (Not_yet_recruiting)
- Ziekenhuis Oost-Limburg — Genk, Belgium (Recruiting)
Study contacts
- Study coordinator: Steven Thiessen
- Email: steven.thiessen@zol.be
- Phone: 3289804646
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.