The Effect of Corticosteroids on Quality of Life Following Total Hip Arthroplasty: HIPSTER Study
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age60+
SponsorZiekenhuis Oost-Limburg
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
aged 60 years or older;
scheduled for elective total hip arthroplasty;
procedure under spinal anaesthesia.
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Dexamethasone (IV)
DrugDexamethasone 5 mg IV
Dexamethasone (IV)
DrugDexamethasone 25 mg IV
Treatment groups
224 Participants
are divided into 2 treatment groupsGroup A: Intervention group 1Active comparator 1 intervention
Group B: Intervention group 2Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Preoperative and postoperative day 30, day 60 and day 90Secondary outcomes
1
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.
Time frame
Preoperative and postoperative day 1, day 3 and day 52
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.
Time frame
Preoperative and postoperative day 30, day 60 and day 903
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.
Time frame
Postoperative day 30, day 60 and day 904
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.
Time frame
Preoperative and postoperative day 30, day 60 and day 90Other outcomes
1
NRS pain score at rest
Numeric rating scale (NRS) pain score ranging from 0 to 10 with 0 reflecting no pain and 10 reflecting the worst pain at rest will be assessed postoperative at 8 a.m. and 6 p.m. each day up to day 5 following surgery.
Time frame
Postoperative at 8 a.m. and 6 p.m. each day up to day 5 following surgery2
NRS pain score at movement
Numeric rating scale (NRS) pain score ranging from 0 to 10 with 0 reflecting no pain and 10 reflecting the worst pain at movement will be assessed postoperative at 8 a.m. and 6 p.m. each day up to day 5 following surgery.
Time frame
Postoperative at 8 a.m. and 6 p.m. each day up to day 5 following surgery3
NRS worst pain past 24 hours
Numeric rating scale (NRS) pain score ranging from 0 to 10 with 0 reflecting no pain and 10 reflecting the worst pain in the past 24 hours will be assessed postoperative at 6 p.m. each day up to day 5 following surgery.
Time frame
Postoperative at 6 p.m. each day up to day 5 following surgery4
Use of analgesics in the past 24 hours
Use of analgesics in the past 24 hours will be assessed postoperative at 6 p.m. each day up to day 5 following surgery.
Time frame
Postoperative at 6 p.m. each day up to day 5 following surgerySponsors and contacts
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Source ClinicalTrials.gov