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

A thoracolumbar fracture is a break of the spine in the mid to low back and is the most common spine fracture. It is usually caused by trauma such as a traffic accident, a fall from height or certain sports.

It is important for the edges of the broken bone to line up closely next to each other to heal. If the broken bone pieces move they can cause damage to the nerves. Often the fracture may fit one of two types, those which are at risk of moving out of place and those which will stay in place. Many surgeons agree that when the fracture could be easily moved out of place and involves nerve damage, surgery is needed. When the injury is a fracture that will stay in place, with no nerve damage, it can be treated without surgery. This usually means using a brace to hold the spine still and slowly increasing activity.

Some injuries are in the middle of these two types of fracture. Some surgeons might be more likely to fix these fractures with surgery as they believe this could reduce the risk of nerve problems or the risk of the spine developing an abnormal curve. However, other surgeons are more likely to use a brace to stabilise the spine, as there is some evidence that suggests this can be an effective treatment and the risks of having surgery on the spine include nerve damage and infection. There are risks and benefits with both treatments. Although both treatments are used widely throughout the NHS, it is not clear which works best.

We are undertaking a study to assess the feasibility of a trial comparing surgical fixation with initial non-operative management in patients with relatively stable thoracolumbar fractures. There are three components to the study:

  1. a multi-centre, randomised controlled feasibility trial to assess the primary outcome of recruitment rate; to establish the willingness of clinicians to randomise and adhere to randomisation and whether there are sufficient eligible patients that are willing to be randomised, to power a full RCT.
  2. a qualitative study to explore patient experience and barriers to recruitment and randomisation from both the patient’s and clinician’s viewpoint.
  3. a UK wide survey of surgeons who treat thoracolumbar fractures will be conducted. The survey will capture information on current management strategies, methods of treatment, willingness to randomise to a future trial and current caseload.

Setting

Recruitment will take place in three secondary care NHS Trusts, two in England and one in Wales.

Target Population

The target population is patients 16 years old or older with a clinical diagnosis of a relatively stable, radiographically confirmed thoracolumbar fracture.

Sample Size:
There will be a 12 month recruitment period across the three centres. Based on initial discussions with the centres it is estimated that there will be at least 120 eligible patients. We aim to recruit 50% of eligible patients giving a sample size of 60.

Health Technologies Being Assessed

Surgical Fixation: Surgical fixation will consist of open or percutaneous pedicle screw fixation. Both procedures include placement of pedicle screws, through different surgical approaches. Open surgery sometimes also includes fusion in addition to stabilisation.

Non-operative management: Non-surgical treatment in the control arm will consist of mobilisation in a brace or mobilisation without a brace as recommended by the treating surgeon in consultation with the patient.
The trial is pragmatic. Surgeons will follow local guidelines/practice, and post-treatment care will not be standardised.

Measurement of Costs and Outcomes: As this is a feasibility study, a full economic evaluation is not included but appropriate and accurate data collection for the full study will be tested.

Use of Participant Personal Data

If you would like to find out more about how we will use participant personal data and what rights study participants have under the General Data Protection Regulation (GDPR), please read our PRESTO GDPR Transparency Information Sheet (PDF , 498kb).

Privacy Notice: How we use your research data

Funding

Funder(s) National Institute for Health Research Health Technology Assessment Programme 
Start Date: September 2017
Expiry Date: September 2019

Members

Internal Staff

External Collaborators

PRESTO is a collaboration between South Tees Hospitals NHS Foundation Trust (Trial Sponsor), the University of York (trial management, statistics and health economics), Barts Health NHS Trust (Chief Investigator Site), University of Newcastle (Qualitative aspect), Leeds Teaching Hospitals NHS Foundation Trust (participating site) and Cardiff and Vale University Health Board (participating site).
Chief Investigator

Trials and Statistics Research in the Department of Health Sciences