Title: Surgical fixation versus non-operative management for patients with stable thoracolumbar fractures: a feasibility study
Funder: Department of Health and Social Care

Abstract: Design We will undertake 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: (i) a multi-centre, randomised controlled feasibility trial to assess the primary outcome of recruitment rate; (ii) a qualitative study to explore patient experience and barriers to recruitment and randomisation; (iii) a UK–wide survey of surgeons, to include current management strategies, methods of treatment, willingness to randomise to a future trial and current caseload. Setting Three secondary care NHS Trusts, two in England and one in Wales. Target Population Patients 16 years old or older with a clinical diagnosis of a relatively stable, radiographically confirmed thoracolumbar fracture will be eligible for the trial. Patients who have declined or agreed to participate in the trial and spinal surgeons will be invited to participate the qualitative study. A national sample of spinal surgeons will be used for the survey. 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. 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. The primary outcome of the feasibility trial will be recruitment rate. 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 60 eligible patients. We aim to recruit 50% of eligible patients giving a sample size of 30. If we identify 60 eligible patients as anticipated, we will be able to estimate a participation rate of 50% to within a 95% confidence interval of ±13%. Randomisation Randomisation will be done by York Trials Unit's secure, web-based service to ensure allocation concealment. Project timetables including recruitment rate 25 month duration, 5 month set-up period, with a 12 month recruitment period which will commence in month 6 and complete in month 17. There will be a minimum 3 month follow-up of patients. Outcomes will also be collected at six months following randomisation for those participants who reach that follow-up point before the end of the study. There will be a 5 month period for analysis and write-up. If we identify 60 eligible patients as anticipated we will be able to estimate a participation rate of 50% to within a 95% confidence interval of ±13%. Expertise in team: Team members have expertise in surgical and non-surgical management of patients with thoracolumbar fractures; design, analysis and conduct of orthopaedic surgical trials (including trials where surgery is being compared to non-surgical management), feasibility studies, statistics, qualitative methods and experience of having treatment for this condition.

Lay abstract: 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. The best way to find out is to complete a randomised controlled trial but this may be difficult to do. This could be 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 will 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. X-rays and CT scans will be used to assess spinal alignment and fracture healing at 3 and 6 months. These appointments 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. Results of the study will be made public via professional associations for surgeons and physiotherapists and via websites such as AfterTrauma.

Research activity codes: 6.4 SURGERY;6.7 PHYSICAL
Health categories: INJURIES AND ACCIDENTS