老年人横向压缩型 1 骨折固定术（L1FE）：一项比较 INFIX 手术与非手术治疗治疗横向压缩型 1（LC-1）脆性骨折患者效果的随机对照试验（带内部预试验）研究方案。
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.
机构信息
York Trials Unit, Department of Health Sciences, University of York, Heslington, YO10 5DD, UK.
Pelvic and Acetabular Reconstruction Unit, Southmead Hospital, Bristol, BS10 5NB, UK.
出版信息
Trials. 2023 Feb 2;24(1):78. doi: 10.1186/s13063-022-07063-5.
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.
背景
外侧压缩型 1 型（LC-1）脆性骨折是老年人中常见的、疼痛的损伤，导致活动能力降低。随着老年人口的增加，这种骨折的发病率正在增加。目前的治疗标准是非手术治疗；然而，这种损伤的患者有长期卧床和相关并发症的风险。INFIX 是一种用于高能量骨折年轻患者的骨盆固定装置。该设备通过经皮技术安装，没有外部销钉部位，即使在骨质疏松的骨骼中也有良好的固定。因此，它有可能在 LC-1 脆性骨折患者中得到很好的耐受。INFIX 可以提高患者的活动能力，并降低与卧床相关的并发症风险。然而，手术相关并发症的风险仍然存在，需要有关于患者结局的有力证据。本研究将调查 INFIX 手术固定与非手术治疗老年 LC-1 脆性骨折的临床和成本效益。
方法
一项多中心随机对照试验，纳入 600 例患者，1:1 随机分配至非手术治疗或 INFIX 手术组。该研究将进行为期 12 个月的内部预试验，以评估招募和试验可行性。主要结局是患者在 6 个月时的生活质量，采用患者报告的 EQ-5D-5L 进行测量。次要结局包括身体功能、心理健康、疼痛、谵妄、影像学评估、资源利用和并发症。
讨论
L1FE 研究旨在比较手术和非手术治疗 60 岁及以上 LC-1 脆性骨折患者的临床和成本效益。该试验具有足够的效力和严格的设计，可以为未来的临床和患者决策以及 NHS 资源的分配提供信息。
试验注册
国际标准随机对照试验注册号 ISRCTN85515454。于 2019 年 4 月 8 日注册。
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