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. 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. 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. 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).

中文翻译：

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稳定胸腰椎骨折治疗结果的务实随机评估（PRESTO）：随机对照可行性试验与定性研究和调查相结合的研究方案

胸腰椎骨折是最常见的脊柱骨折。在骨折不是明显稳定或不稳定的情况下，最佳管理是不确定的。外科医生、治疗中心和证据基础之间在是否应该使用手术或非手术方法方面存在差异。此外，该稳定性不确定性区域的边界尚不清楚。本研究旨在响应 NIHR HTA 委托简报，以评估进行大规模试验以评估手术和非手术治疗无神经功能缺损的胸腰椎骨折的有效性的可行性。可行性评估将通过三个要素来解决：随机外部可行性研究、全国外科医生调查和定性研究。外部可行性研究是一项实用的平行组随机对照试验，比较了手术固定（干预）与非手术治疗（对照）。招聘将在英国的三个二级护理中心进行。主要结果是招募率，定义为随机化的合格参与者的比例。将收集与招募、随机化、辍学、交叉、失访、结果数据的完整性、研究过程和所提供干预措施的细节有关的进一步结果。外科医生的调查和临床医生、招聘人员和患者的定性研究将加强可行性研究，除了感知到的促进因素和开展全面试验的障碍外，还可以广泛了解该领域的当前实践。PRESTO 是一项可行性研究，旨在为比较稳定的胸腰椎骨折患者的手术固定与非手术治疗的最终试验提供方法学信息。该试验已在国际标准随机对照试验注册中心 (ISRCTN12094890) 注册。注册日期为 22/02/2018 (http://www.isrctn.com/ISRCTN12094890)。