Clinical trial • Phase IV • Musculoskeletal|Other

Dexamethasone sodium phosphate for Total hip arthroplasty

Phase IV trial of Dexamethasone sodium phosphate for Total hip arthroplasty.

Overview

Trial Therapeutic Area: Musculoskeletal|Other
Trial Disease: Total hip arthroplasty
Trial Stage: Phase IV
Drug Modality: Small molecule

Key dates

Initial CTIS Submission Date: 05-11-2025
First CTIS Authorization Date: 21-01-2026

Trial design

Aacidexam (dexamethasone sodium phosphate) single intraoperative dose 25 mg IV (intravenous bolus injection/IV infusion) (comparator); Aacidexam (dexamethasone sodium phosphate) single intraoperative dose 5 mg IV (intravenous bolus injection/IV infusion) (test)-controlled Phase IV trial across 1 site in Belgium.

Comparator: Aacidexam (dexamethasone sodium phosphate) single intraoperative dose 25 mg IV (intravenous bolus injection/IV infusion) (comparator); Aacidexam (dexamethasone sodium phosphate) single intraoperative dose 5 mg IV (intravenous bolus injection/IV infusion) (test)
Target Sample Size: 224
Trial Duration For Participant: 90

Eligibility

Recruits 224 Vulnerable populations not selected. Exclusion criterion: 'lack of informed consent or inability to give informed consent'. No additional consent/assent procedures or vulnerable-population handling described..

Vulnerable Population: Vulnerable populations not selected. Exclusion criterion: 'lack of informed consent or inability to give informed consent'. No additional consent/assent procedures or vulnerable-population handling described.

Inclusion criteria

{"criterion_text":"- aged 60 years or older\n- scheduled for elective total hip arthroplasty\n- procedure under spinal anaesthesia"}

Exclusion criteria

{"criterion_text":"- hip revision surgery (reoperation)\n- bilateral total hip arthroplasty during the same procedure\n- 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\n- lack of informed consent or inability to give informed consent\n- urgent, non-elective surgery"}

Endpoints

Primary endpoints

{"endpoint_text":"- Health-related quality of life (EQ-5D-5L) on day 30, 60 and 90 following surgery","definition_or_measurement_approach":"Measured using the EQ-5D-5L instrument at postoperative days 30, 60 and 90"}

Secondary endpoints

{"endpoint_text":"- Quality of recovery (QoR-15) on day 1, day 3, and day 5 following surgery\n- Health-related quality of life (EQ-VAS) on day 30, 60 and 90 following surgery\n- Oxford Hip Score (OHS) on day 30, 60 and 90 following surgery\n- Brief Pain Inventory (BPI) on day 30, 60 and 90 following surgery\n- Chalder fatigue questionnaire (CFQ) on day 30, 60 and 90 following surgery","definition_or_measurement_approach":"QoR-15 measured on days 1, 3, 5 postoperatively; EQ-VAS, OHS, BPI and CFQ measured at postoperative days 30, 60 and 90 using the respective standardized instruments"}

Recruitment

Planned Sample Size: 224
Recruitment Window Months: 12
Consent Approach: Informed consent required from participants. Exclusion: 'lack of informed consent or inability to give informed consent'. Subject information and informed consent form documents available (L1_ICF). No details on assent, age-specific documents or languages specified.

Geography

Total Number Of Sites: 1
Total Number Of Participants: 224

Belgium

Earliest CTIS Part Ii Submission Date: 03-01-2026
Latest Decision Or Authorization Date: 21-01-2026
Processing Time Days: 18
Number Of Sites: 1
Number Of Participants: 224

Sites

Site Name: Ziekenhuis Oost Limburg
Department Name: Critical Care Department
Contact Person Name: Steven Thiessen
Contact Person Email: steven.thiessen@zol.be

Sponsor

Primary sponsor

Full Name: Ziekenhuis Oost Limburg
Organisation Type: Hospital/Clinic/Other health care facility
Country Of Registered Address: Belgium

Investigational products

Investigational Product Name: Aacidexam 5 mg/ml oplossing voor injectie
Active Substance: Dexamethasone sodium phosphate
Modality: Small molecule
Routes Of Administration: Intravenous bolus injection/IV infusion
Route: Intravenous bolus injection/IV infusion
Authorisation Status: Authorised (marketing authorisation BE080026)
Starting Dose: 5 mg
Dose Levels: Single intraoperative dose of 5 mg
Frequency: Single intraoperative dose
Maximum Dose: 5 mg

Investigational Product Name: Aacidexam 5 mg/ml solution injectable
Active Substance: Dexamethasone sodium phosphate
Modality: Small molecule
Routes Of Administration: Intravenous bolus injection/IV infusion
Route: Intravenous bolus injection/IV infusion
Authorisation Status: Authorised (marketing authorisation BE080026)
Starting Dose: 25 mg
Dose Levels: Single intraoperative dose of 25 mg
Frequency: Single intraoperative dose
Maximum Dose: 25 mg

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