Lateral compression type-1 fracture fixation in the elderly (L1FE). Study Protocol for a randomised controlled trial (with internal pilot) comparing the effects of INFIX surgery and non-surgical management for treating patients with Lateral Compression type-1 (LC-1) fragility fractures

Background: Lateral compression type-1 (LC-1) fragility fractures are a common, painful injury in older adults resulting in reduced mobility. The incidence of these fractures is increasing with the growing older adult population. Current standard of care is non-surgical management, however patients with this injury are at risk of long term immobility and the related complications. INFIX is a pelvic fixation device used in younger patients with high energy fractures. The device is fitted via a percutaneous technique with no external pin sites and has good purchase even in osteoporotic bone. It therefore has the potential to be well tolerated in patients with LC-1 fragility fractures. INFIX could improve patients’ ability to mobilise and reduce the risk of immobility related complications. However, there is a risk of complications related to surgery and robust evidence is required on patient outcomes. This study will investigate the clinical and cost effectiveness of surgical fixation with INFIX compared to non-surgical management of LC-1 fragility fractures in older adults. Methods: A multi-centre randomised controlled trial of 600 patients allocated 1:1 to non-surgical management or INFIX surgery. The study will have a 12-month internal pilot to assess recruitment and trial feasibility. The primary outcome will be patient quality of life over 6 months, measured by the patient reported EQ-5D-5L. Secondary outcomes will include physical function, mental health, pain, delirium, imaging assessment, resource use and complications. Discussion: The L1FE study aims to compare the clinical and cost effectiveness of surgical and non-surgical management of people aged 60 years and older with LC-1 fragility fractures. The trial is sufficiently powered and rigorously designed to inform future clinical and patient decision making and allocation of NHS resources. Trial Registration: Trial Identifier: ISRCTN16478561. Registry Name: International Standard Randomised Controlled Trial Number Registry. Registered: 8th April 2019