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PRESTO – Pragmatic Randomised Evaluation of Stable Thoracolumbar fracture treatment Outcomes: a feasibility study

There is uncertainty about whether surgical or conservative management is best for stable fractures and whether a randomised controlled trial would be feasible. This study concluded that a full trial is unlikely to be feasible mainly owing to the low proportion of patients eligible.

Why did we do this research?

There is informal consensus that simple compression fractures of the body of the thoracolumbar vertebrae without neurological complications can be managed conservatively and that obvious unstable fractures require surgical fixation. However, there is a zone of uncertainty about whether surgical or conservative management is best for stable fractures.

What did we do?

We carried out a feasibility randomised controlled trial using block randomisation, stratified by centre and type of injury (high- or low-energy trauma) to allocate participants 1 : 1 to surgery or conservative treatment. We also undertook a costing analysis; a national survey of spine surgeons; and a qualitative study with clinicians, recruiting staff and patients. Surgical fixation involved open spinal surgery (with or without spinal fusion) or minimally invasive stabilisation surgery. Conservative management involved mobilisation with or without a brace.

Who was involved?

Adults aged 16 years and above with a high- or low-energy fracture of the body of a thoracolumbar vertebra between the 10th thoracic vertebra and the second lumbar vertebra, confirmed by imaging and meeting other inclusion criteria were recruited at three NHS hospitals. 

What did we find?

A definitive trial is unlikely to be feasible currently, mainly because of the small number of patients meeting the eligibility criteria: of 211 patients screened, 28 met the criteria. The recruitment and follow-up rates were slightly lower than anticipated; however, there is room to increase these based on information gathered and the support within the surgical community for a future trial.

 Publications

• Cook E, Scantlebury A, Booth A, et al. Surgery versus conservative management of stable thoracolumbar fracture: the PRESTO feasibility RCT. Health Technol Assess. 2021 Nov;25(62):1-126. https://doi.org/10.3310/hta25620 PMID: 34780323
• Arabella Scantlebury, Catriona McDaid, Elizabeth Cook, Joy Adamson, Evidence based spinal surgery or the “journal of anecdotal medicine?” Using qualitative interviews with spinal surgeons to understand how the drivers of orthopaedic decision making can influence the creation and adoption of surgical trial evidence, SSM - Qualitative Research in Health Volume 2, 2022, 100092, ISSN 2667-3215, https://doi.org/10.1016/j.ssmqr.2022.100092 
• Cook, E., Booth, A., Coleman, E. et al. 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 Feasibility Stud 6, 38 (2020). https://doi.org/10.1186/s40814-020-00574-5

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