TrAFFiX
Research type
Research Study
Full title
Trial of Acute Femoral Fracture Fixation (TrAFFix)
IRAS ID
206745
Contact name
Xavier Griffin
Contact email
Sponsor organisation
University of Oxford
ISRCTN Number
ISRCTN92089567
Duration of Study in the UK
1 years, 6 months, 31 days
Research summary
This will be a preliminary study to plan a larger trial to determine whether there is a difference between two operations for patients with a fractured thigh bone. We plan to compare 'locking plates’ where a plate is screwed to the surface of the bone, with 'nail fixation' where a rod is inserted into the centre of the bone. This project will identify any barriers to the delivery of a larger study and determine the number of patients who can take part.
Patients 50 years old and above who are treated for a break at the bottom end of the thigh bone will be potentially eligible to take part. The broad criteria will ensure that the results can support future treatment decisions for as many patients as possible; a large number of these patients have dementia so it is important that they are represented. Participants will be randomly assigned their treatment to ensure that the same number of each treatment is assigned at each hospital, and for participants with and without dementia.
The demographic details and pre-injury health status will be recorded using questionnaires. When participants have memory problems then someone who knows the participant well can answer the questionnaires. The questionnaires will be completed again at 6 weeks and 4 months after the injury.
The main outcome will be measured at 4 months, when most participants will have recovered substantially. We will also evaluate the processes surrounding the delivery of treatments to help us to understand the important components of the treatments, how the treatments are delivered, and what local factors might influence outcomes. This evaluation will include interviews with patients and their friends or family, and with staff members, and will help us to prepare any future definitive trial.
REC name
Wales REC 5
REC reference
16/WA/0225
Date of REC Opinion
1 Aug 2016
REC opinion
Further Information Favourable Opinion