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

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.

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 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.

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.

The EQ VAS 0-100 (range) is a visual analogue scale where 0 represents the worst imaginable health state and 100 represents the best. Higher scores on the EQ VAS indicate a better health outcome.

Short Falls Efficacy Scale International (Short-FES-I) measures concern about falling during various activities, with scores ranging from 7 (no concern about falling) to 28 (severe concern about falling). Higher scores indicate greater concern about falling.

Participants are encouraged to stand and fully sit as many times as possible within 30 seconds, with correct form monitored by the tester. If a participant uses their arms, they score a 0, and only correctly executed stands are counted. This test assesses a wide range of ability levels. Lower score indicates worse outcome.

Barthel 20 Index measures a patient's level of independence in daily activities, with scores ranging from 0 (complete dependence) to 20 (complete independence). Higher scores indicate a better outcome, reflecting greater independence.

Hip fracture-related pain will be assessed using the Verbal Rating Scale for Pain, which ranges from 0 to 4. A score of 0 indicates no pain, while a score of 4 represents unbearable or the worst imaginable pain

The DAH30 is determined using a combination of electronic medical records (obtaining length of stay) and direct participant inquiries at the 6 week follow up

SAE defined following the ICH - GCP guidelines

The time of death is determined using validated registry-based data, from which survival rates, as well as 30-day and 90-day mortality rates, are calculated.

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.

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.

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.

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.

Exploratory Outcome E: Cognition will be assessed using the Orientation-Memory-Concentration (OMC) test to examine potential differences between the groups. The OMC test range from 0-28 points, with a score of 25-27 indicating no or minimal cognitive impairment, and a score of 0-7 indicating severe impairment.

Exploratory Outcome F: This outcome focuses on assessing the ferritin levels in both the intervention and placebo groups. Ferritin will be measured in ng/mL. The aim is to determine how intravenous iron therapy affects ferritin levels in comparison to the placebo group.

Explorative outcome G: Transferrin saturation, measured as a percentage, will be assessed in both the intervention and placebo groups. This outcome will evaluate how transferrin saturation is affected by intravenous iron therapy compared with placebo.