Title: Trial of Acute Femoral Fracture Fixation (TrAFFix). A feasibility study
Funder: Department of Health and Social Care

Abstract: This will be a feasibility study for a pragmatic, multicentre, randomised controlled trial. The feasibility study will inform the development of a definitive trial to provide evidence whether there is a clinical and cost-effectiveness difference between locking plate fixation and retrograde intramedullary nail fixation in patients with an acute, extra-articular fragility fracture of the distal femur. The study will take place in 6 centres over a period of 18 months. The aim will be to determine the number of eligible and recruited patients in the trauma centres. Screening logs will be kept at each site to determine the number of patients assessed for eligibility and reasons for any exclusions. In addition, the number of eligible and recruited patients, and the number of patients who decline consent or withdraw will be recorded. As well as recording participant flow through the study, we will refine trial procedures in participating centres. Adult patients over 50 years of age, including those with cognitive impairment, presenting at the trial centres with an acute, extra-articular fragility fracture of the distal femur will be eligible to take part in the trial. The broad eligibility criteria will ensure that the results of the study can readily be generalised to the wider patient population. A computer generated randomisation sequence, stratified by centre and cognitive impairment will be produced and administered independently by a secure web-based service. Randomisation will be on a 1:1 basis to retrograde intramedullary nail or locking plate fixation. Both of these operations are widely used within the NHS and all of the surgeons in the chosen centres will be familiar with both techniques. Baseline demographic data, radiographs and pre-injury functional and quality-of-life data using the EuroQol 5 Dimensions Score, Dementia Quality of Life Score, Disability Rating Index will be collected. Outcomes in participants with cognitive impairment will be reported by a proxy. Recent research in a similar group of patients, those with hip fracture, has shown EQ-5D to be a valid and responsive measure in this particular group of patients. Follow-up will be scheduled at 6 weeks and 4 months. These time-points reflect routine clinical practice and will minimise the participant burden. Outcomes at one year will be important in a full trial, but are not required for this feasibility study. The primary outcome will be determined at 4 months, when the majority of recovery has been attained by this population of patients. Participants or proxies will report the patient-reported outcome measures recorded at baseline. The main statistical analysis will investigate differences in the primary outcome measure, the EQ-5D at 4 months after surgery, between the two treatment groups on an intention-to-treat basis. In parallel with the feasibility study am independent process evaluation will be performed. The evaluation will focus on investigating the fidelity and quality of implementation, clarifying the causal mechanisms and identifying the contextual factors which might be important in variation of outcome. We will identify and work with stakeholders to define a logic model for the complex intervention. From this model we will develop the key assumptions which underpin the intervention within the settings of the feasibility study.

Lay abstract: This will be a preliminary study to plan a larger, definitive, randomised trial in multiple hospitals to compare two current treatments in the NHS. The future trial will provide evidence to determine whether there is a difference between two common operations for patients with a fracture at the lower end of the thigh bone. We plan to compare 'locking plate fixation' where a plate is screwed to the surface of the bone, with 'nail fixation' where a rod is inserted into the hollow centre of the thigh bone. Currently, we do not know which is the better treatment. This preliminary project will focus on any barriers to the successful delivery of the larger study. The study will determine the number of patients who are able and willing to take part in the trial across 6 separate NHS hospitals. The number of eligible and recruited patients, and the number of patients who do not participate will be recorded. All adult patients treated for a break of the end of the thigh bone, including those with dementia, will be potentially eligible to take part in the trial. The broad eligibility criteria will ensure that the results of this study can be used to support future treatment decisions for as many patients as possible and throughout the NHS; a large number of these patients have dementia so it is important that they are represented in the study. Participants will be given one or other treatment by chance using a computer programme. This programme will ensure that the number of each of the treatments used in each hospital, and for participants with and without dementia or confusion, will be balanced. Details of the age and sex of the patients, x-rays and pre-injury health status will be recorded using questionnaires. Someone who knows the participant well will answer health questionnaire for those with memory problems. Follow-up will be scheduled at 6 weeks and 4 months. These time-points are the same as those used as part of normal practice and will therefore minimise the burden of the study for participants. The main outcome will be determined at 4 months, when most participants will have recovered substantially from the injury. At each follow-up point participants or their carer will complete the questionnaires again to assess their recovery. The main statistical analysis will investigate differences in the recovery of the patients 4 months after surgery. In parallel with the feasibility study we will also evaluate the processes surrounding the delivery of the treatments. This evaluation will help us to understand the important components of the treatments, how the treatments are delivered and important local factors that might influence outcomes. Information from this evaluation will help us to better prepare any future definitive trial.

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