Abstract
BackgroundA thoracolumbar fracture is the most common fracture of the spinal column. Where the fracture is not obviously stable or unstable, the optimal management is uncertain. There are variations between surgeons, treating centres and within the evidence base as to whether surgical or non-surgical approaches should be used. In addition, the boundaries of this zone of uncertainty for stability are unclear.This study has been designed in response to an NIHR HTA commissioning brief to assess the feasibility of undertaking a large-scale trial to evaluate the effectiveness of surgical and non-surgical treatments for thoracolumbar fractures without neurological deficit.MethodsAssessment of feasibility will be addressed through three elements: a randomised external feasibility study, a national survey of surgeons and a qualitative study.The external feasibility study is a pragmatic, parallel-group, randomised controlled trial comparing surgical fixation (intervention) versus non-surgical management (control). Recruitment will take place in three secondary care centres in the UK.The primary outcome is recruitment rate, defined as the proportion of eligible participants who are randomised. Further outcomes related to recruitment, randomisation, drop-out, cross-over, loss to follow-up, completeness of outcome data, study processes and details of the interventions delivered will be collected.The survey of surgeons and qualitative study of clinicians, recruiting staff and patients will enhance the feasibility study, enabling a broad overview of current practice in the field in addition to perceived facilitators and barriers to running a full-scale trial.DiscussionPRESTO is a feasibility study which aims to inform methodology for a definitive trial comparing surgical fixation with non-surgical management for patients with stable thoracolumbar fractures.Trial registrationThe trial is registered with the International Standard Randomised Controlled Trial Register (ISRCTN12094890). Date of registration was 22/02/2018 (http://www.isrctn.com/ISRCTN12094890).
Highlights
A thoracolumbar fracture is the most common fracture of the spinal column
How can we accurately identify, quantify and value economic data to capture the impact of the two treatments on the National Health Services (NHS) and productivity?
Have a diagnosis of a high- or low-energy impact thoracolumbar vertebral body fracture, between T10 and L2, and confirmed by radiograph, computed tomography (CT) scan or magnetic resonance imaging (MRI) with at least ONE of the following criteria: (a) A kyphotic angle greater than 20° on standing radiographs, or if lying CT or radiograph 15° of kyphosis; or (b) Reduction of vertebral body height by 25%; or (c) Fracture line propagating through the posterior wall of vertebra; or (d) Two contiguous vertebrae involved; or (e) Injury to the posterior longitudinal ligament (PLL) or annulus in addition to the body fracture
Summary
Setting Participants that fulfil trial inclusion criteria will be enrolled from participating secondary care centres. Patients will be provided with written information and given the opportunity to discuss and ask questions about the trial with research staff and their treating surgical team prior to making a decision on participation. 15 to 20 spinal surgeons from across the UK or staff recruiting patients to the feasibility study will be interviewed to discuss current practice regarding treatment of thoracolumbar fractures to determine facilitators and barriers to running a full-scale trial, and the potential of changing practice as a result of the findings. These meetings focus on aspects of patient recruitment (e.g. screening, consent, eligibility), allocation to study groups, adherence of the trial interventions to the protocol, monitoring of adverse events and reasons for patient withdrawal, and retention of trial participants. The oversight committee advises on strategies to preserve the integrity of the trial where required
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
