Authors' objectives: 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.

Project Status: Completed

URL for project: http://www.nets.nihr.ac.uk/projects/hta/155922

Year Published: 2019

URL for published report: https://www.journalslibrary.nihr.ac.uk/programmes/hta/155922#/

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: England, United Kingdom

Organisation Name: NIHR Health Technology Assessment programme

Contact Address: NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK

Contact Name: journals.library@nihr.ac.uk

Contact Email: journals.library@nihr.ac.uk

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