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

Trials

Study Protocol

Catherine Hilton¹  Jamila Kassam¹  Peter Bates¹  Dhanupriya Sivapathasuntharam¹  Peter Hull²  Daren Forward³  Mehool Acharya⁴  Belen Corbacho⁵  Camila Maturana⁵  Jenny Roche⁵  Laura Doherty⁵  Joanne Laycock⁵  Catherine Hewitt⁵  Catriona Mcdaid⁵  Elizabeth Cook⁵  David Torgerson⁵  Michael Ross Backhouse⁶ 

[1] Bart’s Health NHS Trust, The Royal London Hospital, Whitechapel Road, Whitechapel, E1 1BB, London, UK;Cambridge University Hospitals NHS Foundation Trust, Hills Road, CB2 0QQ, Cambridge, UK;Nottingham University Hospitals, Derby Road, NG7 2UH, Nottingham, UK;Pelvic and Acetabular Reconstruction Unit, Southmead Hospital, BS10 5NB, Bristol, UK;York Trials Unit, Department of Health Sciences, University of York, YO10 5DD, Heslington, UK;York Trials Unit, Department of Health Sciences, University of York, YO10 5DD, Heslington, UK;Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, CV4 7AL, Coventry, UK;

关键词: INFIX surgery;    Lateral compression type 1;    LC-1;    Pelvic fracture fixation;    Elderly patients;    Older adults;    Fragility fracture;    Osteoporotic bone;    Pubic ramus fracture;    Immobility-related complications;   

DOI  :  10.1186/s13063-022-07063-5

 received in 2022-11-07, accepted in 2022-12-30,  发布年份 2022

来源: Springer

【 摘 要 】

BackgroundLateral compression type1 (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. The current standard of care is non-surgical management; however, patients with this injury are at risk of long-term immobility and 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.MethodsA 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 the patient quality of life over 6 months, measured by the patient-reported EQ-5D-5L. The secondary outcomes will include physical function, mental health, pain, delirium, imaging assessment, resource use, and complications.DiscussionThe 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 registrationInternational Standard Randomised Controlled Trial Number Registry ISRCTN16478561. Registered on 8 April 2019

【 授权许可】

CC BY   
© The Author(s) 2023

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