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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\u2019 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.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>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 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.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Discussion<\/jats:title>\n                <jats:p>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.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial registration<\/jats:title>\n                <jats:p>International Standard Randomised Controlled Trial Number Registry ISRCTN16478561. Registered on 8 April 2019<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s13063-022-07063-5","type":"journal-article","created":{"date-parts":[[2023,2,2]],"date-time":"2023-02-02T11:05:55Z","timestamp":1675335955000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["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"],"prefix":"10.1186","volume":"24","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6902-0235","authenticated-orcid":false,"given":"Elizabeth","family":"Cook","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joanne","family":"Laycock","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mehool","family":"Acharya","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael Ross","family":"Backhouse","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Belen","family":"Corbacho","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura","family":"Doherty","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daren","family":"Forward","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Catherine","family":"Hewitt","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Catherine","family":"Hilton","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Hull","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jamila","family":"Kassam","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Camila","family":"Maturana","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Catriona","family":"Mcdaid","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jenny","family":"Roche","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dhanupriya","family":"Sivapathasuntharam","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Torgerson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Bates","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2023,2,2]]},"reference":[{"issue":"9","key":"7063_CR1","doi-asserted-by":"publisher","first-page":"e0139078","DOI":"10.1371\/journal.pone.0139078","volume":"10","author":"S Andrich","year":"2015","unstructured":"Andrich S, Haastert B, Neuhaus E, Neidert K, Arend W, Ohmann C, et al. 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The HRA has also given governance approval. In addition, the study was reviewed and given approval by Scotland A REC (REF 21\/SS\/0002), which is specifically related to the inclusion of patients who lack the capacity to consent in Scotland.Written, informed consent to participate will be obtained from all participants with capacity. Participants have the right to withdraw from the study at any time and for any reason, and all participants are made aware that withdrawal will not affect their routine care. The study will include patients who lack capacity, and as appropriate, consultee declaration will be sought from a personal or nominated consultee (in England, Wales, and Northern Ireland) or consent will be sought from a guardian, welfare attorney, or nearest relative (in Scotland). The process for seeking consultee declaration for patients lacking capacity in England, Wales, and Northern Ireland has been approved by the Research Ethics Committee in England and will be in accordance with the Mental Capacity Act 2005 for England and Wales and in accordance with the Mental Capacity Act (NI) 2016 for Northern Ireland. The process for seeking consent for patients who lack capacity in Scotland will be in accordance with the Adults with Incapacity Act (Scotland) 2000 and approved by the Research Ethics Committee in Scotland. The Mental Capacity Act 2005, the Mental Capacity Act (NI) 2016, and the Adults with Incapacity Act (Scotland) 2000 establish a framework for the protection of the rights of people who lack the capacity to decide for themselves. They are designed to ensure that the interests and rights of people who lack capacity are protected and that their current and previously expressed wishes are respected.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable since there are no identifying images or other personal or clinical details of participants presented. Informed consent materials are available from the corresponding author.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"P Bates holds educational contracts with Johnson and Johnson and Zimmer Biomet, for delivering teaching, visitations, and webinars. He is one of the design surgeons for a pelvic plating system, <i>Phoenix<\/i> manufactured by ITS. Importantly, this plating system is not used in the treatment of fragility LC-1 pelvic fractures. He is a senior lecturer at QMUL, in Orthopaedic Trauma Sciences.C McDaid is a member of the NIHR HTA and EME Journal Editorial Board and has received funding from the British Orthopaedic Association to support grant applications.C Hewitt is a member of the NIHR HTA commissioning committee (2015 to present) and Deputy Chair (2019 to present).These associations and grants have not in any way influenced the contribution to this study.The other authors declare that they have no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"78"}}