Projects per year
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
|Accepted/In press - 31 Dec 2022