World Hip Trauma Evaluation - FRUITI: Fix or Replace Undisplaced Intracapsular fractures Trial of Interventions

BACKGROUND Worldwide there are 1.3 million hip fractures with more than 70,000 hip fractures in the UK every year; projected to rise to more than 100,000 by 2020 in the UK. The global cost of this clinical problem is estimated at 1.75 million disability adjusted life years lost and represents 1.4% of the total healthcare burden in established market economies. People suffering hip fracture have a 30 day mortality of 7% and experience a persistent reduction in their health-related quality-of-life similar to that of a major stroke. Minimally displaced intracapsular fractures represent approximately ten to fifteen per cent of all hip fractures. Conventional treatment to stabilise the fracture with internal fixation is a quick procedure with minimal blood loss and has the key advantage of preserves the person’s own hip joint. However, healing can be unsuccessful in many patients requiring revision surgery in up to 20% of cases. Hip replacement surgery eliminates the risk of fixation failure as the femoral neck is replaced. However, it is a more major operation than internal fixation with very significant complications of its own including a greater risk of infection, dislocation and periprosthetic fracture. AIM This study aims to determine whether there is a difference in health-related quality of life at four months after surgery in people aged 60 years and above with undisplaced intracapsular fractures treated with internal fixation or hip replacement. DESIGN Pragmatic, multicentre, two-arm randomised controlled superiority trial with parallel economic analyses with direct patient follow-up to one year. Longterm followup will be achieved using routinely collected data at 5 years. The primary outcome is the EuroQol 5 Dimensions (EQ5D) at 4 months after randomisation. METHODS All patients aged 60 and over with a minimally displaced intracapsular fracture are potentially eligible to take part in this study. Eligible patients will be identified in daily trauma meetings and approached for recruitment prior to their treatment where possible. Patients who lack capacity may be entered into the trial under a pre-specified consultee agreement. Treatments will be performed in hospitals across the UK by a wide range of surgeons to ensure generalisability. Eight hundred and 78 participants (439 per group) will be randomly allocated to internal fixation or hip replacement. Other components of both interventions including patient position, implant choice and type of anaesthesia will be at the discretion of the clinical team. The trial will employ 1:1 random allocation by a remote computer system, stratified by centre. Data regarding quality of life, complications and costs will be collected at six weeks, four, and twelve months. The primary outcome measure is health-related quality-of-life measured using the EQ-5D at four months from randomisation with a parallel economic analysis. TIMELINES FOR DELIVERY The trial is set to commence in February and report to HTA in October 2024. A report of long-term outcomes at five years will be produced by December 2028. ANTICIPATED IMPACT AND DISSEMINATION The 12 months results will be presented and published internationally. Patient representatives will help disseminate the results through patient advocacy groups and beyond routine scientific media. We expect the trial to be included in NICE hip fracture guideline (CG124) at their scheduled update in 2025.