Title: TULIP: a randomised controlled Trial of sUrgical versus non-surgical treatment of Lateral compression Injuries of the Pelvis with complete sacral fractures (LC1) in the non-fragility fracture patient - a feasibility study
Funder: Department of Health and Social Care

Abstract: BACKGROUND A Lateral Compression type 1 (LC1) pelvic fracture occurs from a wide spectrum of injuries. The majority of LC1 fractures are deemed to be stable to allow rehabilitation without subsequent displacement. A sub-group of LC1 fractures which have a complete sacral fracture are potentially less stable. These may be treated operatively or non-operatively. Patients with LC1 fractures are reported to spend significant time in hospital following their injury and require significant rehabilitation following their discharge. Patients may not return to their pre-injury level of function for many months and much of the cost following pelvic injury is attributed to absence from work. Surgical treatment of these injuries, using metalwork to prevent displacement of the fracture, may reduce patients level of pain and allow earlier mobilisation. However previous, non-randomised studies, have provided conflicting evidence on this. Other potential advantages of surgical treatment include avoiding the risks associated with immobility, including infection, thrombosis and pressure sores. Surgery may provide economic benefits by reducing length of hospital stay and input required from healthcare professionals which may outweigh the additional costs of the surgery. The disadvantages of treating LC1 fractures surgically are the risks associated with general anaesthesia, and the small risk of infection and of damage to the nerves that supply the bladder, bowel or leg muscles. RESEARCH QUESTION Is surgical stabilisation or non-operative treatment the most clinically and cost effective treatment option for patients with non-fragility, lateral compression injuries of the pelvis involving complete sacral fractures? AIM The aim is to perform a feasibility study to plan a full definitive trial to answer this research question. RESEARCH PLAN Population All patients aged 16 years and older with an unstable, LC1 fracture sustained as a result of high-energy trauma. Patients will be excluded if they were unable to mobilise 6m prior to injury or are unfit for anaesthesia. Sixty patients will be recuited from five UK Major Trauma Centres, 30 being randomised to surgical treatment and 30 to non-operative. Intervention A pragmatic approach to both treatments will be taken and data will be collected on various aspects of the treatment. All centres participating in the study regularly perform surgery on these patients. Outcomes Patients will be asked to complete a variety of outcome measures to evaluate pain, function and quality of life. These will be completed at routine clinical appointments (6 weeks, 3 and 12 months), and postally (2 weeks, 6 and 9 months). Data will also be collected on their inpatient stay and any complications. This feasibility study will confirm the recruitment rate and review the completeness and spread of data from these outcome measures at the different timepoints. This will allow the identification of the primary outcome measure at a set time point from the completeness and sensitivity to change over time. The appropriate data collection methods for an economic evaluation to be performed in a future full study will also be refined. Twenty patients and 10 staff will be interviewed to explore their experiences of the trial to inform a larger main RCT. Views on recruitment and randomisation will also be explored in 10 brief interviews and discussion with patients who decline to take part. Dissemination The results of the study will be published in an open access journal. If a future full study is proved feasible, an application to fund this study will be made to the HTA. It is anticipated that this main study will indicate whether surgical or non-surgical management of unstable LC1 fractures is most beneficial to patients, and the wider economy.

Lay abstract: The pelvis can get broken in different ways. The most common is called Lateral Compression type 1 (LC1). Most of these injuries occur as a result of a significant fall or impact from the side. Traditionally LC1 breaks were treated without an operation. This may lead to ongoing pain, longer periods of immobility and progressive deformity. If an operation is performed, the surgeon will use plates and screws to stabilise the pelvis. It is thought by doing this there is a possibility of less pain, improved mobility and lower rates of deformity. Patients may also be discharged from hospital sooner. The aim of this study is to find out if it would be feasible to conduct a definitive trial to test whether having an operation or not is better in treating this injury. Patients with a LC1 fracture will be reviewed by their consultant who will discuss the study with them. Patients who consent to the study will be randomised to either having an operation or not. Following discharge from hospital all patients will be reviewed at regular intervals by the surgeon to assess the patients recovery through clinical examination, a simple walking test and short questionnaires. The questionnaires ask about their symptoms, and the physical, emotional, social and financial impact. These questionnaires have been selected with help from patients who have had a broken pelvis and highlighted what was important to monitor throughout recovery. Most questionnaires will be completed during hospital visits (6 weeks, 3 and 12 months). When patients are not routinely reviewed in hospital, questionnaires will be posted (2 weeks, 6 and 9 months). Study results will help design a larger study and will be published in medical journals. Participants will be informed of the results, and the findings publicised in hospitals patient and public involvement days.

Research activity codes: 6.4 SURGERY
Health categories: INJURIES AND ACCIDENTS