PRESTO (Treatment of stable thoracolumbar fractures: feasibility)
Research type
Research Study
Full title
Surgical fixation versus non-operative management for patients with stable thoracolumbar fractures: a feasibility study
IRAS ID
223912
Contact name
Arun Ranganathan
Contact email
Sponsor organisation
South Tees Hospitals NHS Foundation Trust
ISRCTN Number
12094890
Duration of Study in the UK
1 years, 3 months, days
Research summary
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.
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. However, other surgeons are more likely to use a brace to stabilise the spine.
There are risks and benefits with both treatments. Although both treatments are used widely
throughout the NHS, it is not clear which works best. The best way to find out is to complete a randomised controlled trial but this may be difficult to do because surgeons and patients might have strong ideas about which treatment they prefer.Due to these challenges a study to find out if a larger trial would be possible is needed. This study will have the following aims:
1) To test if we can recruit enough people to a full trial to compare surgery with non-operative
treatment for mid-low spinal fractures.
2) To test if we can collect the data needed to answer the research question.Patients aged 16 years or older with spinal fractures will be invited to take part in the study. Surgeons will review their injury to ensure that they meet the criteria. Participants will be provided with information about both treatments; these information sheets have been reviewed by a patient panel to ensure that they explain the study well.
If they agree to participate they will be in one of two groups. One group will receive surgery and the other will be managed without surgery. Participants will be advised about what will happen if it becomes necessary to change treatment at a later date.
Participants will be asked to complete questionnaires about their activity and quality of life. Routine X-rays and CT scans will be used to assess spinal alignment and fracture healing at 3 and 6 months. All trial visits and scans will be in line with the appointments that would usually be needed for clinical care.
Some participants and surgeons involved in the study will be invited to take part in an interview to help design the main trial.
We will undertake a national survey of surgeons to investigate if they would be willing to recruit patients to a future trial.
At the end of the study we will make recommendations about whether a full trial is feasible and how the design of the study could be improved.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
18/NE/0008
Date of REC Opinion
20 Mar 2018
REC opinion
Further Information Favourable Opinion