Department of Trauma & Orthopaedics, North Bristol NHS Trust, Southmead Hospital, Bristol, UK.
Bristol Medical School, University of Bristol, Bristol, UK
BMJ Open. 2020 Feb 10;10(2):e036588. doi: 10.1136/bmjopen-2019-036588.
Lateral compression type 1 (LC1) pelvic fractures are the most common type of pelvic fracture. The majority of LC1 fractures are considered stable. Fractures where a complete sacral fracture is present increases the degree of potential instability and have the potential to displace over time. Non-operative management of these unstable fractures may involve restricted weight bearing and significant rehabilitation. Frequent monitoring with X-rays is also necessary for displacement of the fracture. Operative stabilisation of these fractures may be appropriate to prevent displacement of the fracture. This may allow patients to mobilise pain-free, quicker.
The study is a feasibility study to inform the design of a full definitive randomised controlled trial to guide the most appropriate management of these injuries. Participants will be recruited from major trauma centres and randomly allocated to either operative or non-operative management of their injuries. A variety of outcome instruments, measuring health-related quality of life, functional outcome and pain, will be completed at several time points up to 12 months post injury. Qualitative interviews will be undertaken with participants to explore their views of the treatments under investigation and trial processes.Eligibility and recruitment to the study will be analysed to inform the feasibility of a definitive trial. Completion rates of the measurement instruments will be assessed, as well as their sensitivity to change and the presence of floor or ceiling effects in this population, to inform the choice of the primary outcome for a definitive trial.
Ethical approval for the study was given by the South West-Central Bristol NHS Research Ethics Committee on 2nd July 2018 (Ref; 18/SW/0135). The study will be reported in relevant specialist journals and through presentation at specialist conferences.
ISRCTN10649958.
横向挤压型 1 型（LC1）骨盆骨折是最常见的骨盆骨折类型。大多数 LC1 骨折被认为是稳定的。存在完全骶骨骨折的骨折会增加潜在不稳定性的程度，并有可能随着时间的推移发生移位。这些不稳定骨折的非手术治疗可能包括限制负重和大量康复。还需要频繁进行 X 射线监测以防止骨折移位。这些骨折的手术稳定可能适合防止骨折移位。这可以使患者更快地无痛移动。
该研究是一项可行性研究，旨在为一项全面的确定性随机对照试验提供信息，以指导这些损伤的最佳治疗方法。参与者将从主要创伤中心招募，并随机分配接受手术或非手术治疗其损伤。将在受伤后长达 12 个月的几个时间点完成各种测量健康相关生活质量、功能结果和疼痛的结果工具。将对参与者进行定性访谈，以探讨他们对正在研究的治疗方法和试验过程的看法。将分析研究的资格和招募情况，以了解确定性试验的可行性。将评估测量工具的完成率，以及它们在该人群中的变化敏感性和地板或天花板效应的存在，以确定确定性试验的主要结局。
该研究于 2018 年 7 月 2 日获得了西南中部布里斯托尔 NHS 研究伦理委员会的伦理批准（参考号：18/SW/0135）。该研究将在相关专业期刊上报告，并通过专业会议进行介绍。
ISRCTN85455166.
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