Pragmatic randomised evaluation of stable thoracolumbar fracture treatment outcomes (PRESTO): study protocol for a randomised controlled feasibility trial combined with a qualitative study and survey

Pilot and Feasibility Studies

Arun Ranganathan¹  Peter May¹  Catherine Hilton¹  Sashin Ahuja²  Almas Khan³  Amar Rangan⁴  David J. Torgerson⁵  Joy Adamson⁶  Catherine Hewitt⁶  Emma Turner⁶  Arabella Scantlebury⁶  Elizabeth Cook⁶  Catriona McDaid⁶  Belen Corbacho⁶  Alison Booth⁶  Elizabeth Coleman⁶ 

[1] Bart’s Health NHS Trust, The Royal London Hospital;Cardiff & Vale University Health Board, University Hospital of Wales;Leeds Teaching Hospitals NHS Trust, Leeds General Infirmary;South Tees Hospitals NHS Foundation Trust, The James Cook University Hospital;York Trials Unit and NIHR RDS YH, Department of Health Sciences, Faculty of Science, ARRC Building, University of York;York Trials Unit, Department of Health Sciences, University of York;

关键词: Thoracolumbar;    Fracture;    Surgical fixation;    Randomised controlled trial;    Qualitative;    Survey;   

DOI  :  10.1186/s40814-020-00574-5

来源: DOAJ

【 摘 要 】

Abstract Background A 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. Methods Assessment 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. Discussion PRESTO 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 registration The trial is registered with the International Standard Randomised Controlled Trial Register (ISRCTN12094890). Date of registration was 22/02/2018 ( http://www.isrctn.com/ISRCTN12094890 ).

【 授权许可】

Unknown