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
Abstract Background Lateral 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; howeve...
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| Format: | Article |
| Language: | English |
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BMC
2023-02-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-022-07063-5 |
| _version_ | 1811171598687797248 |
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| author | Elizabeth Cook Joanne Laycock Mehool Acharya Michael Ross Backhouse Belen Corbacho Laura Doherty Daren Forward Catherine Hewitt Catherine Hilton Peter Hull Jamila Kassam Camila Maturana Catriona Mcdaid Jenny Roche Dhanupriya Sivapathasuntharam David Torgerson Peter Bates |
| author_facet | Elizabeth Cook Joanne Laycock Mehool Acharya Michael Ross Backhouse Belen Corbacho Laura Doherty Daren Forward Catherine Hewitt Catherine Hilton Peter Hull Jamila Kassam Camila Maturana Catriona Mcdaid Jenny Roche Dhanupriya Sivapathasuntharam David Torgerson Peter Bates |
| author_sort | Elizabeth Cook |
| collection | DOAJ |
| description | Abstract Background Lateral 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. 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 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. 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 International Standard Randomised Controlled Trial Number Registry ISRCTN16478561. Registered on 8 April 2019 |
| first_indexed | 2024-04-10T17:16:45Z |
| format | Article |
| id | doaj.art-f29621a438cc40f29dd3cf0726972e04 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-10T17:16:45Z |
| publishDate | 2023-02-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-f29621a438cc40f29dd3cf0726972e042023-02-05T12:22:53ZengBMCTrials1745-62152023-02-0124111610.1186/s13063-022-07063-5Lateral 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 fracturesElizabeth Cook0Joanne Laycock1Mehool Acharya2Michael Ross Backhouse3Belen Corbacho4Laura Doherty5Daren Forward6Catherine Hewitt7Catherine Hilton8Peter Hull9Jamila Kassam10Camila Maturana11Catriona Mcdaid12Jenny Roche13Dhanupriya Sivapathasuntharam14David Torgerson15Peter Bates16York Trials Unit, Department of Health Sciences, University of YorkYork Trials Unit, Department of Health Sciences, University of YorkPelvic and Acetabular Reconstruction Unit, Southmead HospitalYork Trials Unit, Department of Health Sciences, University of YorkYork Trials Unit, Department of Health Sciences, University of YorkYork Trials Unit, Department of Health Sciences, University of YorkNottingham University HospitalsYork Trials Unit, Department of Health Sciences, University of YorkBart’s Health NHS Trust, The Royal London HospitalCambridge University Hospitals NHS Foundation TrustBart’s Health NHS Trust, The Royal London HospitalYork Trials Unit, Department of Health Sciences, University of YorkYork Trials Unit, Department of Health Sciences, University of YorkYork Trials Unit, Department of Health Sciences, University of YorkBart’s Health NHS Trust, The Royal London HospitalYork Trials Unit, Department of Health Sciences, University of YorkBart’s Health NHS Trust, The Royal London HospitalAbstract Background Lateral 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. 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 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. 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 International Standard Randomised Controlled Trial Number Registry ISRCTN16478561. Registered on 8 April 2019https://doi.org/10.1186/s13063-022-07063-5INFIX surgeryLateral compression type 1LC-1Pelvic fracture fixationElderly patientsOlder adults |
| spellingShingle | Elizabeth Cook Joanne Laycock Mehool Acharya Michael Ross Backhouse Belen Corbacho Laura Doherty Daren Forward Catherine Hewitt Catherine Hilton Peter Hull Jamila Kassam Camila Maturana Catriona Mcdaid Jenny Roche Dhanupriya Sivapathasuntharam David Torgerson Peter Bates 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 INFIX surgery Lateral compression type 1 LC-1 Pelvic fracture fixation Elderly patients Older adults |
| 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | INFIX surgery Lateral compression type 1 LC-1 Pelvic fracture fixation Elderly patients Older adults |
| url | https://doi.org/10.1186/s13063-022-07063-5 |
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