The effect op corticosteroids on quality of life following total hip arthroplasty: HIPSTER study

The primary objective of this study is to evaluate the effect of different doses of a single intraoperative dose of dexamethasone (5 mg versus 25 mg) on health-related quality of life up to three months after surgery. This investigation is clinically relevant for optimizing perioperative corticosteroid dosing strategies in patients aged 60 years or older undergoing total hip arthroplasty, potentially informing evidence-based approaches to enhance postoperative recovery and functional outcomes in this elderly surgical population.

The sponsor did not provide information regarding the total number of participants enrolled in this clinical trial. The study population comprised **male and female patients** aged **60 years or older** who were scheduled for elective **total hip arthroplasty** under **spinal anaesthesia**. Participants represented an **elderly population** undergoing orthopedic surgery. The trial focused on patients requiring this specific surgical intervention, with the procedure performed using a defined anesthetic technique. No vulnerable populations were included in the study. The sponsor did not provide detailed information regarding participants' general health status, lifestyle factors, or additional selection criteria beyond the age requirement and the planned surgical procedure.

This clinical trial is designed as a **randomized**, **controlled** study to evaluate the effect of different doses of a single **intraoperative** dose of **dexamethasone sodium phosphate** on **health-related quality of life** in patients aged 60 years or older undergoing **total hip arthroplasty**. The trial compares two dose levels: 5 mg versus 25 mg of dexamethasone, administered as a **solution for injection** via **intravenous bolus injection** or **intravenous infusion** during the surgical procedure performed under **spinal anaesthesia**. The study is classified as a **Phase IV** trial investigating the possible benefit of an already authorized investigational medicinal product. The trial is categorized as a **low intervention clinical trial**.

The **primary endpoint** is health-related quality of life assessed using the **EQ-5D-5L** questionnaire on days 30, 60, and 90 following surgery. **Secondary endpoints** include quality of recovery measured by the **QoR-15** questionnaire on days 1, 3, and 5 after surgery, health-related quality of life assessed by **EQ-VAS** on days 30, 60, and 90, the **Oxford Hip Score** on days 30, 60, and 90, the **Brief Pain Inventory** on days 30, 60, and 90, and the **Chalder fatigue questionnaire** on days 30, 60, and 90 following surgery.

**Principal inclusion criteria** for participation are: patients aged 60 years or older, scheduled for elective total hip arthroplasty, and undergoing the procedure under spinal anaesthesia. The **screening visit** involves verification of eligibility criteria prior to enrolment. Participants receive a single dose of the investigational medicinal product during surgery, with a maximum daily dose of either 25 mg or 5 mg and a maximum total dose of 25 mg or 5 mg respectively, administered over a treatment period of 1 day.

**Follow-up visits** are scheduled at multiple time points postoperatively to assess recovery and quality of life outcomes. Early postoperative assessments occur on days 1, 3, and 5, followed by subsequent evaluations on days 30, 60, and 90. The **end-of-study visit** corresponds to the final assessment at day 90 following surgery. The estimated duration of participant involvement is approximately three months from the date of surgery. The overall trial duration extends from the estimated recruitment start date of March 1, 2026, to the estimated end date of February 28, 2027. Conditions that may lead to **early termination** from the study are not specified in the available trial information.

The experimental treatment consists of **Aacidexam 5 mg/ml solution injectable**, a **solution for injection** containing **dexamethasone sodium phosphate** as the active substance. This medicinal product is manufactured by ASPEN PHARMA TRADING LIMITED and is authorized in Belgium under marketing authorization number BE080026. The pharmaceutical form is a solution for injection administered via **intravenous bolus injection** or **intravenous infusion**. In the test treatment arm, participants receive a single **intraoperative dose** of 25 mg dexamethasone sodium phosphate. The maximum daily dose is 25 mg, and the maximum total dose is 25 mg, administered over a treatment period of 1 day. The active substance is of chemical origin.

The **comparator treatment** utilizes Aacidexam 5 mg/ml oplossing voor injectie, which is the same medicinal product as the test treatment, containing dexamethasone sodium phosphate as the active substance in an identical pharmaceutical form. This product is also manufactured by ASPEN PHARMA TRADING LIMITED and holds the same marketing authorization number BE080026 in Belgium. The route of administration is intravenous bolus injection or intravenous infusion. In the comparator arm, participants receive a single intraoperative dose of 5 mg dexamethasone sodium phosphate. The maximum daily dose is 5 mg, and the maximum total dose is 5 mg, administered over a treatment period of 1 day.

Efficacy will be assessed using multiple validated instruments measuring different aspects of patient outcomes following total hip arthroplasty. The primary efficacy endpoint is health-related quality of life measured by the EQ-5D-5L questionnaire at day 30, day 60, and day 90 following surgery. Secondary efficacy endpoints include quality of recovery assessed using the QoR-15 scale on day 1, day 3, and day 5 following surgery. Additional secondary endpoints comprise health-related quality of life measured by the EQ-VAS at day 30, day 60, and day 90 following surgery, functional hip outcomes evaluated using the Oxford Hip Score at day 30, day 60, and day 90 following surgery, pain assessment through the Brief Pain Inventory at day 30, day 60, and day 90 following surgery, and fatigue levels measured by the Chalder Fatigue Questionnaire at day 30, day 60, and day 90 following surgery. These measurements will enable comprehensive evaluation of the effect of different intraoperative doses of dexamethasone on patient outcomes over a three-month postoperative period.