World Hip Trauma Evaluation - FRUITI: Fix or Replace Undisplaced Intracapsular fractures Trial of Interventions
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.
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.
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.
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.
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.
The researchers will ask patients about their health, 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.
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.
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.
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.