Postoperative Quality of RecoveryPhase 4HIPSTERNCT07378215
The Effect of Corticosteroids on Quality of Life Following Total Hip Arthroplasty: HIPSTER Study
A Phase 4 study testing Dexamethasone (IV) in people with Postoperative Quality of Recovery and Health-Related Quality-of-Life, run by Ziekenhuis Oost-Limburg at 2 sites in Belgium.
Trial summary
Total hip arthroplasty (THA) is a highly effective and commonly performed procedure for end-stage osteoarthritis. Perioperative inflammation contributes to postoperative pain, fatigue, and delayed recovery. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Postoperative Quality of Recovery, Health-Related Quality-of-Life, Quality of Life
- What is being tested?
- Dexamethasone (IV)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 2 sitesBelgium
- Study dates
- 30 Jan 2026to Feb 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 60 years or older;
- scheduled for elective total hip arthroplasty;
- procedure under spinal anaesthesia.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium2 sites, 2 recruiting
- Not yet recruiting
Ziekenhuis Oost-Limburg
Genk, Limburg, 3600
Steven Thiessen, 3289804646, steven.thiessen@zol.be
Steven Thiessen
- Recruiting
Ziekenhuis Oost-Limburg
Genk
Wencke Renette, MD, 03289804646, wencke.renette@zol.be
About this study
Total hip arthroplasty (THA) is a highly effective and commonly performed procedure for end-stage osteoarthritis. Perioperative inflammation contributes to postoperative pain, fatigue, and delayed recovery. Dexamethasone, a potent glucocorticoid with strong anti-inflammatory properties, is widely used in orthopedic surgery and incorporated into Enhanced Recovery After Surgery (ERAS) protocols for THA to reduce pain, PONV, and fatigue. While intermediate doses of dexamethasone (25 mg) are considered safe and beneficial in the short term, their long-term effects on health-related quality of life and persistent pain remain unclear.
Therefore, the main objective of the HIPSTER trial is to evaluate the effect of different doses of a single intraoperative intravenous dose of dexamethasone (5 mg versus 25 mg) on health-related quality of life up to three months after surgery.
Read the detailed description
Total hip arthroplasty (THA) is a successful and cost-effective treatment for end-stage osteoarthritis and other degenerative hip conditions. It is one of the most frequently performed surgical procedures worldwide and continues to increase in volume each year, largely due to the growing population of older adults. Despite its effectiveness, THA is associated with significant surgical trauma that induces a pronounced inflammatory response, leading to postoperative pain, fatigue, postoperative nausea and vomiting (PONV), prolonged hospital stays, and delayed functional recovery. Prevention of postoperative inflammation can be a crucial cornerstone to optimize recovery and enhance outcomes after THA.
Dexamethasone, a potent and long-acting glucocorticoid with strong anti-inflammatory properties, is widely used in orthopedic surgery. It suppresses prostaglandin synthesis by downregulating cyclooxygenase-2 expression, thereby inhibiting cell adhesion factor expression and cytokine gene transcription. Dexamethasone also reduces neutrophil and macrophage exudation and activity at inflammatory sites, decreasing cellular adhesion and aggregation along vascular endothelium. Although dexamethasone has a short half-life of approximately 36-72 hours, by modulating the surgical stress response and its multiple downstream effects on inflammation, acute pain, nausea, and fatigue, it may also influence longer-term outcomes. Due to these mechanisms, dexamethasone has become an integral component of perioperative management in various surgical disciplines, including THA.
Previous studies have demonstrated that perioperative dexamethasone administration can attenuate inflammatory responses, reduce PONV, and acute postoperative pain and fatigue in patients undergoing THA. These short-term benefits translate into improved early postoperative recovery, which can be quantified using validated instruments such as the Quality of Recovery-15 (QoR-15) score. Consequently, dexamethasone is now commonly incorporated into Enhanced Recovery After Surgery (ERAS) protocols for THA. Intermediate glucocorticoid doses - equivalent to 25 mg of dexamethasone - are generally considered safe and are part of the standard of care in many arthroplasty centers performing primary THA.
While the short-term benefits of dexamethasone on postoperative inflammation, acute pain control, PONV reduction, early recovery, and hospital length of stay are well established in THA, concerns remain regarding its long-term safety profile. Several studies have reported potential adverse effects associated with intermediate to high doses, such as impaired sleep quality, immunosuppression, and possible wound-healing complications. Although glucocorticoids at the implemented doses have demonstrated efficacy in reducing acute postoperative pain, their role in preventing chronic postsurgical pain (CPSP) remains unclear, with some studies suggesting even a trend to persistent wound pain with higher doses of dexamethasone. Furthermore, the long-term effects of perioperative dexamethasone on health-related quality of life (HRQoL) following THA have not yet been systematically investigated.
As health-related quality of life, assessed by EQ-5D, is an important patient-reported outcome following anaesthesia and surgery, as emphasised in the StEP-COMPAC initiative, the effect of different doses of dexamethasone on health-related quality of life needs further investigation.
Therefore, the main objective of the HIPSTER trial is to evaluate the effect of different doses of a single intraoperative intravenous dose of dexamethasone (5 mg versus 25 mg) on health-related quality of life up to three months after surgery.
- Being tested
- Dexamethasone (IV)
- Keywords
- Hip Arthroplasty, Older adult patients, Dexamethasone, Enhanced Recovery After Surgery (ERAS), Quality of recovery, Quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone (IV)Drug
Also called Aacidexam (IV)
Dexamethasone 5 mg IV
Dexamethasone (IV)Drug
Also called Aacidexam (IV)
Dexamethasone 25 mg IV
| Study group | Role | What they receive |
|---|---|---|
| Intervention group 1 | Active comparator | A single intraoperative dose of intravenous dexamethasone 5 mg Receives: Drug: Dexamethasone (IV) |
| Intervention group 2 | Active comparator | A single intraoperative dose of intravenous dexamethasone 25 mg Receives: Drug: Dexamethasone (IV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related quality of life (EQ5D5L)
The EQ5D is used for measuring health-related quality of life. EQ5D5L provides a single index value for health status which can be used to assess overall health. The descriptive profile consists of five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels of severity: no problems, slight problems, moderate problems, severe problems, or not able. Respondents select the level that best describes their current health status. The questionnaire will be taken preoperatively, on day 30, day 60 and day 90 following surgery.
Measured: Preoperative and postoperative day 30, day 60 and day 90
Secondary outcomes (5)
Quality of Recovery (QoR)
Quality of Recovery Score (QoR-15) is a patient-reported outcome measurement which will be used to assess the early postoperative health status of the patient after surgery and anesthesia, i.e. the quality of recovery. The score is arbitrary and ranges from 0 to 150, the higher the score the better the quality of recovery. QoR-15 will be assessed preoperatively and on day 1, day 3 and day 5 following surgery.
Measured: Preoperative and postoperative day 1, day 3 and day 5
Health-related quality of life (EQ-VAS)
The EQ5D visual analog scale (VAS) EQ-VAS is used for measuring health-related quality of life. In the EQ-VAS respondents rate their current health status on a scale from 0 to 100, with 0 being the worst imaginable health and 100 being the best imaginable health state. The score will be taken preoperatively, on day 30, day 60 and day 90 following surgery.
Measured: Preoperative and postoperative day 30, day 60 and day 90
Oxford Hip Score (OHS)
The OHS is a joint-specific, patient-reported outcome measure designed to assess disability in patients undergoing total hip replacement surgery. It is a short 12-item survey where patients are asked to reflect on their pain and functional ability over the previous four weeks. There are two domains, pain and function, with six items in each. Each item has five possible responses. Item scores are summed to give a total score between 0 and 48. The lower the score, the better the outcome. The questionnaire will be done on day 30, day 60 and day 90 following surgery.
Measured: Postoperative day 30, day 60 and day 90
Brief Pain Inventory (BPI)
The BPI consists of 15 items and measures pain intensity and interference. The questionnaire comprises items regarding medications and analgesics, pain interference and intensity, relationships, mood, quality of life, and physical activities such as sleep, general activity and walking. Higher scores indicate greater severity and pain interference. The questionnaire will be done preoperative, on postoperative day 30, day 60 and day 90.
Measured: Preoperative and postoperative day 30, day 60 and day 90
Chalder fatigue questionnaire (CFQ)
To assess general fatigue a fatigue questionnaire, the CFQ, will be taken preoperative and on day 30, day 60 and day 90 following surgery. The CFQ consists of 11 items that assess both physical and mental aspects of fatigue. Respondents rate each item ranging from 0 to 3, the scores are then totaled to provide a measure of overall fatigue, a higher score meaning more severe fatigue.
Measured: Preoperative and postoperative day 30, day 60 and day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start30 Jan 2026
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Quality of RecoveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziekenhuis Oost-Limburg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07378215
- Sponsor's protocol ID
- Z-2025125
- Other IDs
- 2025-524368-39-00, 2025
- Acronym
- HIPSTER
- Status last verified
- Jan 2026
- First submitted
- 22 Jan 2026
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Corticosteroids on Quality of Life Following Total Hip Arthroplasty: HIPSTER Study
- ClinicalTrials.gov ID
- NCT07378215
- Acronym / sponsor ID
- HIPSTER / Z-2025125
- Keywords
- Hip Arthroplasty, Older adult patients, Dexamethasone, Enhanced Recovery After Surgery (ERAS), Quality of recovery, Quality of life
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- Ziekenhuis Oost-LimburgUniversity, hospital or other
- Study start
- 30 Jan 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 30 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Total hip arthroplasty (THA) is a highly effective and commonly performed procedure for end-stage osteoarthritis. Perioperative inflammation contributes to postoperative pain, fatigue, and delayed recovery. Dexamethasone, a potent glucocorticoid with strong anti-inflammatory properties, is widely used in orthopedic surgery and incorporated into Enhanced Recovery After Surgery (ERAS) protocols for THA to reduce pain, PONV, and fatigue. While intermediate doses of dexamethasone (25 mg) are considered safe and beneficial in the short term, their long-term effects on health-related quality of life and persistent pain remain unclear.
Therefore, the main objective of the HIPSTER trial is to evaluate the effect of different doses of a single intraoperative intravenous dose of dexamethasone (5 mg versus 25 mg) on health-related quality of life up to three months after surgery.
Detailed description
Total hip arthroplasty (THA) is a successful and cost-effective treatment for end-stage osteoarthritis and other degenerative hip conditions. It is one of the most frequently performed surgical procedures worldwide and continues to increase in volume each year, largely due to the growing population of older adults. Despite its effectiveness, THA is associated with significant surgical trauma that induces a pronounced inflammatory response, leading to postoperative pain, fatigue, postoperative nausea and vomiting (PONV), prolonged hospital stays, and delayed functional recovery. Prevention of postoperative inflammation can be a crucial cornerstone to optimize recovery and enhance outcomes after THA.
Dexamethasone, a potent and long-acting glucocorticoid with strong anti-inflammatory properties, is widely used in orthopedic surgery. It suppresses prostaglandin synthesis by downregulating cyclooxygenase-2 expression, thereby inhibiting cell adhesion factor expression and cytokine gene transcription. Dexamethasone also reduces neutrophil and macrophage exudation and activity at inflammatory sites, decreasing cellular adhesion and aggregation along vascular endothelium. Although dexamethasone has a short half-life of approximately 36-72 hours, by modulating the surgical stress response and its multiple downstream effects on inflammation, acute pain, nausea, and fatigue, it may also influence longer-term outcomes. Due to these mechanisms, dexamethasone has become an integral component of perioperative management in various surgical disciplines, including THA.
Previous studies have demonstrated that perioperative dexamethasone administration can attenuate inflammatory responses, reduce PONV, and acute postoperative pain and fatigue in patients undergoing THA. These short-term benefits translate into improved early postoperative recovery, which can be quantified using validated instruments such as the Quality of Recovery-15 (QoR-15) score. Consequently, dexamethasone is now commonly incorporated into Enhanced Recovery After Surgery (ERAS) protocols for THA. Intermediate glucocorticoid doses - equivalent to 25 mg of dexamethasone - are generally considered safe and are part of the standard of care in many arthroplasty centers performing primary THA.
While the short-term benefits of dexamethasone on postoperative inflammation, acute pain control, PONV reduction, early recovery, and hospital length of stay are well established in THA, concerns remain regarding its long-term safety profile. Several studies have reported potential adverse effects associated with intermediate to high doses, such as impaired sleep quality, immunosuppression, and possible wound-healing complications. Although glucocorticoids at the implemented doses have demonstrated efficacy in reducing acute postoperative pain, their role in preventing chronic postsurgical pain (CPSP) remains unclear, with some studies suggesting even a trend to persistent wound pain with higher doses of dexamethasone. Furthermore, the long-term effects of perioperative dexamethasone on health-related quality of life (HRQoL) following THA have not yet been systematically investigated.
As health-related quality of life, assessed by EQ-5D, is an important patient-reported outcome following anaesthesia and surgery, as emphasised in the StEP-COMPAC initiative, the effect of different doses of dexamethasone on health-related quality of life needs further investigation.
Therefore, the main objective of the HIPSTER trial is to evaluate the effect of different doses of a single intraoperative intravenous dose of dexamethasone (5 mg versus 25 mg) on health-related quality of life up to three months after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group 1 | Active comparator | Drug: Dexamethasone (IV)A single intraoperative dose of intravenous dexamethasone 5 mg |
| Intervention group 2 | Active comparator | Drug: Dexamethasone (IV)A single intraoperative dose of intravenous dexamethasone 25 mg |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged 60 years or older;
- scheduled for elective total hip arthroplasty;
- procedure under spinal anaesthesia.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone (IV)Also: Aacidexam (IV)Dexamethasone 5 mg IV | Drug | Intervention group 1 |
| Dexamethasone (IV)Also: Aacidexam (IV)Dexamethasone 25 mg IV | Drug | Intervention group 2 |
Primary outcome
Health-related quality of life (EQ5D5L)
Time frame: Preoperative and postoperative day 30, day 60 and day 90
The EQ5D is used for measuring health-related quality of life. EQ5D5L provides a single index value for health status which can be used to assess overall health. The descriptive profile consists of five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels of severity: no problems, slight problems, moderate problems, severe problems, or not able. Respondents select the level that best describes their current health status. The questionnaire will be taken preoperatively, on day 30, day 60 and day 90 following surgery.
5 secondary outcomes
Quality of Recovery (QoR)
Time frame: Preoperative and postoperative day 1, day 3 and day 5
Health-related quality of life (EQ-VAS)
Time frame: Preoperative and postoperative day 30, day 60 and day 90
Oxford Hip Score (OHS)
Time frame: Postoperative day 30, day 60 and day 90
Brief Pain Inventory (BPI)
Time frame: Preoperative and postoperative day 30, day 60 and day 90
Chalder fatigue questionnaire (CFQ)
Time frame: Preoperative and postoperative day 30, day 60 and day 90
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone (IV) in people with Postoperative Quality of Recovery and Health-Related Quality-of-Life, run by Ziekenhuis Oost-Limburg at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Steven Thiessen (3289804646, steven.thiessen@zol.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-related quality of life (EQ5D5L) (time frame: Preoperative and postoperative day 30, day 60 and day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.