The Effect of Corticosteroids on Quality of Life Following Total Hip Arthroplasty: HIPSTER Study

NCT07378215 | Recruiting Phase 4

• 2 other identifiers: Z-20251252025-524368-39-00
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Postoperative Quality of Recovery; Health-Related Quality-of-Life; Quality of Life

Keywords

Hip Arthroplasty; Older adult patients; Dexamethasone; Enhanced Recovery After Surgery (ERAS); Quality of recovery; Quality of life

Outcome Measures

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.

  Preoperative and postoperative day 30, day 60 and day 90

Secondary Outcomes (5)

• Quality of Recovery (QoR)

  Preoperative and postoperative day 1, day 3 and day 5

• Health-related quality of life (EQ-VAS)

  Preoperative and postoperative day 30, day 60 and day 90

• Oxford Hip Score (OHS)

  Postoperative day 30, day 60 and day 90

• Brief Pain Inventory (BPI)

  Preoperative and postoperative day 30, day 60 and day 90

• Chalder fatigue questionnaire (CFQ)

  Preoperative and postoperative day 30, day 60 and day 90

Other Outcomes (5)

• NRS pain score at rest

  Postoperative at 8 a.m. and 6 p.m. each day up to day 5 following surgery

• NRS pain score at movement

  Postoperative at 8 a.m. and 6 p.m. each day up to day 5 following surgery

• NRS worst pain past 24 hours

  Postoperative at 6 p.m. each day up to day 5 following surgery

Study Arms (2)

Intervention group 1

ACTIVE COMPARATOR

A single intraoperative dose of intravenous dexamethasone 5 mg

Drug: Dexamethasone (IV)

Intervention group 2

ACTIVE COMPARATOR

A single intraoperative dose of intravenous dexamethasone 25 mg

Drug: Dexamethasone (IV)

Interventions

Dexamethasone (IV) DRUG

Dexamethasone 5 mg IV

Also known as: Aacidexam (IV)

Intervention group 1

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 60 years or older;
• scheduled for elective total hip arthroplasty;
• procedure under spinal anaesthesia.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ziekenhuis Oost-Limburg: lead

Study Sites (2)

Ziekenhuis Oost-Limburg

Genk, Limburg, 3600, Belgium

NOT YET RECRUITING

Ziekenhuis Oost-Limburg

Genk, Belgium

RECRUITING

MeSH Terms

Interventions

Dexamethasone; Calcium Dobesilate

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Central Study Contacts

Steven Thiessen

CONTACT

3289804646; steven.thiessen@zol.be

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: January 30, 2026
• Study Start: January 30, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)