Title: World Hip Trauma Evaluation - FRUITI: Fix or Replace Undisplaced Intracapsular fractures Trial of Interventions
Funder: Department of Health and Social Care

Abstract: Every year around 70,000 people in the UK break their hip. Hip fractures are a common and very serious injury in older patients, similar in impact to a major stroke. We will investigate two treatments for one specific type of hip fracture. Currently, surgeons either repair the fracture with screws or remove and replace the broken piece of bone, but we do not know which is better for patients._x000D_ _x000D_ We will examine whether either fixing the broken bone or replacing the hip joint gives a better result for people 60 years and over with hip fracture from 40 hospitals across the UK. We want to look at how well people feel and how active they are a year after their fracture. Over a third of people with a broken hip have memory problems, and as they can struggle to recover from this injury we plan to include them in this study. We will also work out the cost of the two treatments – for the individual, for the health service and in terms of social support in the following year._x000D_ _x000D_ A pilot study in a smaller group of hospitals will look closely at our approach to this work – to check that enough people will want to take part in the full study. This also allows us to improve the study design of the larger study before we get started. All the information from this pilot study will be included in the main study._x000D_ _x000D_ To compare the two treatments properly we think we will need 878 people to take part. If people agree to take part, they will be randomly put into one of two groups by a computer program to make sure that the groups are similar and the comparison is fair. After their operation all the patients will have the usual ward care, rehabilitation and follow up that is standard practice at their hospital._x000D_ _x000D_ The researchers will ask patients about their health, pain, walking ability and other daily activities, as well as any complications and specific costs. Their answers will be collected at the outset, and at 6 weeks, 4 months and 1 year after the injury, and the results from the two groups compared. A few questions will be asked each year for five years to find out about any longer term effects._x000D_ _x000D_ This project was developed by a team of patient representatives, clinical experts in trauma orthopaedics, study management specialists, experienced statisticians and health economists. The Oxford Clinical Trials Research Unit, based at the University of Oxford, will assure the quality of the study. A monitoring committee of patient representatives and independent experts will oversee the progress and conduct of the study.

Lay abstract: BACKGROUND_x000D_ 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._x000D_ _x000D_ 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._x000D_ _x000D_ AIM_x000D_ 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._x000D_ _x000D_ DESIGN_x000D_ 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._x000D_ _x000D_ METHODS_x000D_ 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._x000D_ _x000D_ _x000D_ TIMELINES FOR DELIVERY_x000D_ 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._x000D_ _x000D_ _x000D_ ANTICIPATED IMPACT AND DISSEMINATION_x000D_ 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.

Research activity codes: 6.4 SURGERY
Health categories: INJURIES AND ACCIDENTS