Trial of Acute Femoral Fracture Fixation (TrAFFix). A feasibility study
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.
TrAFFix is funded by the NIHR Health Technology Assessment Programme (Ref: 15/59/22)
The study protocol publication can be found here.
The primary results publication can be found here.
Secondary publications can be found as follows:-
1: A qualitative study of patients' experience of recovery after a distal femur fracture (2019)
2: Facilitating trial recruitment: A qualitative study of patient and staff experiences of an orthopaedic trauma trial (2019)
3: Retrograde intramedullary nail fixation compared with fixed-angle plate fixation for fracture of the distal femur: the TrAFFix feasibility RCT (2019)