Pragmatic Randomised Evaluation of Stable Thoracolumbar fracture treatment Outcomes (PRESTO)

The PRESTO study is a multicentre, pragmatic randomised controlled feasibility trial that aims to establish whether it is possible to deliver a trial comparing surgical fixation to initial non-operative management for adult patients with a relatively stable thoracolumbar fracture without spinal cord injury.

The PRESTO study is funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme. It is a joint collaboration between South Tees Hospitals NHS Foundation Trust (trial sponsor) and the University of York (trial management).

 

Participant inclusion criteria

  • Age 16 years or older
  • Diagnosis of a high- or low-energy impact thoracolumbar vertebral fracture, between T10 and L2, and confirmed by radiograph, computed tomography (CT) scan or magnetic resonance imaging (MRI) with any ONE of the following criteria:
  • A kyphotic angle greater than 20 degrees on standing radiographs, or if lying CT or radiograph then 15 degrees of kyphosis; or
  • Reduction of vertebral body height by 25 percent; or
  • Fracture line propagating through the posterior wall of vertebra; or
  • Two contiguous vertebrae involved; or
  • Injury to the posterior longitudinal ligament (PLL) or annulus in addition to the body fracture.

 

Participant exclusion criteria

  • Unstable fractures which obviously need surgical stabilisation – decision made by the treating surgeon
  • Spinal cord injury
  • Pathological (other than osteoporotic) fracture e.g. tumour/infection
  • Patient not considered suitable for surgery

 

Neurosurgery Recruitment Pathway

  • Thoraco-lumbar fracture identified by Neurosurgery team.
  • Notify Orthopaedic Research on 02035940182
  • You can also call/text Peter May on 07773609079 – please do not include confidential data.
  • If the patient meets the eligibility criteria they will come under Arun Ranganathan.
  • If the patient does not meet the study criteria they will remain under the admitting consultant.