The Effects of Intravenous Iron on Mobility in Elderly Patients Following Hip Fracture Surgery

New Mobility Score (NMS)

The primary outcome is to compare the effect of a single dose of FDI (20 mg/kg body weight) relative to placebo on patients' recovery of functional mobility measured with New Mobility Score. New Mobility Score is a validated patient reported outcome measurement 0-9-point score for hip fracture patients, with 9 point equal to a fully independent indoor, outdoor and during shopping walking ability and 0 point, indicating no walking ability. Higher scores indicate a better outcome.

Hemoglobin

Red blood cell transfusion requirement

This will be measured by the proportion of patients who receive at least one red blood cell unit and the amounts of units per patient

Fatigue, assessed using the Verbal Rating Scale for Fatigue (F-VRS)

Fatigue will be assessed using the Verbal Rating Scale for Fatigue (F-VRS). This scale, ranging from 0 to 4, measures fatigue in hip fracture patients, where 0 indicates no fatigue and 4 represents extreme fatigue.

Quality of life with EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L )

The EQ-5D-5L questionnaire measures health-related quality of life across five dimensions, with scores ranging from 1 (no problems) to 5 (extreme problems). Higher scores indicate worse outcomes, reflecting greater health issues.

A. Cost-effectiveness analysis

Explorative outcome A: Cost-effectiveness analysis will be made from a societal perspective including cost of FDI, hospital bed days, readmissions, outpatient visits and costs related to lost productivity of the patients (production loss). The analysis will be done according to the guidelines for health economic evaluation. The analysis will be based on data from the electronic patient records and data on the duration of patient's sick leave and absence from work from patient surveys. The main results from the analysis will be a comparison of the mean costs per patient in the intervention and the control group, the mean change in Quality Adjusted Life Years gained in the two groups (based on EQ5D) and the incremental cost-effectives ratio.

B. Physical Activity

Explorative outcome B: This outcome focuses on evaluating the effect of intravenous iron on 24-hour physical activity of patients. Physical activity will be measured using the SENS motion activity monitor. Each participant will wear the monitor for 10 days starting at the 6-week follow-up, measuring their time spent lying, sitting, standing, walking, and transitioning between these states. After 10 days, the monitor will be collected, and data will be analyzed to compare the combined amount of time spent standing and walking between the two groups. This outcome will be measured on the participants enrolled at Bispebjerg Hospital.

C. Hand Grip Strength

Explorative outcome C: Hand grip strength will be assessed using a dynamometer measured in kilograms with a higher score representing better hand grip strength. Measured on participants enrolled at Bispebjerg Hospital. This outcome aims to determine how intravenous iron therapy influences hand grip strength, comparing the changes between the two groups.

D. Knee Extension Strength

Explorative outcome D: Knee extension strength will be measured using a dynamometer, measured in Nm/Kg with a higher score representing better Knee extension strength. Measured on participants enrolled at Bispebjerg Hospital. The goal is to examine the effect of intravenous iron therapy on knee extension strength between the two groups at these key points.