英国胫骨远端骨折固定术（UK FixDT）：一项关于“锁定”钢板固定与髓内钉固定治疗成人胫骨远端移位骨折的随机对照试验方案

UK Fixation of Distal Tibia Fractures (UK FixDT): protocol for a randomised controlled trial of 'locking' plate fixation versus intramedullary nail fixation in the treatment of adult patients with a displaced fracture of the distal tibia.

作者信息

Achten Juul, Parsons Nicholas R, McGuinness Katie R, Petrou Stavros, Lamb Sarah E, Costa Matthew L

机构信息

Warwick Medical School, The University of Warwick, Coventry, UK.

Nuffield Department of Orthopaedics, Rheumatology & Musculoskeletal Sciences, University of Oxford, Oxford, UK.

出版信息

BMJ Open. 2015 Sep 18;5(9):e009162. doi: 10.1136/bmjopen-2015-009162.

DOI:10.1136/bmjopen-2015-009162

PMID:26384729

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4577877/

Abstract

INTRODUCTION

The treatment of displaced, extra-articular fractures of the distal tibia remains controversial. These injuries are difficult to manage due to limited soft tissue cover, poor vascularity of the area and proximity to the ankle joint. Surgical treatment options are expanding and include locked intramedullary nails, plate and screw fixation and external fixator systems. The nail and plate options are most commonly used in the UK, but controversy exists over which treatment is most clinically and cost-effective. In this multicentre randomised controlled trial we aim to assess ratings of disability 6 months postinjury in patients who have sustained a distal tibia fracture treated with either an intramedullary nail or plate and locking screw fixation.

METHODS AND ANALYSIS

Adult patients presenting at trial centres with an acute fracture of the distal tibia will be considered for inclusion. A total of 320 patients will provide 90% power to detect a difference of 8 points in Disability Rating Index (DRI) score at 6 months at the 5% level. The randomisation sequence is stratified by trial centre and age, and administered via web-based service with 1:1 treatment allocation. Baseline demographic and pre-injury functional data and radiographs will be collected using the DRI, Olerud and Molander, and EuroQol EQ-5D questionnaire. Clinical assessment, early complications and radiographs will be recorded at 6-8 weeks. Functional outcome, health-related quality of life and resource use will be collected at 3, 6 and 12 months postoperatively. The main analysis will investigate differences in DRI 6 months postsurgery, between the two treatment groups, on an intention-to-treat basis. Tests will be two-sided and considered to provide evidence for a significant difference if p values are <0.05.

ETHICS AND DISSEMINATION

NRES Committee West-Midlands, 6/11/2012 (ref:12/WM/0340). The results of the trial will be disseminated via peer-reviewed publications and presentations at relevant conferences.

TRIAL REGISTRATION NUMBER

ISRCTN99771224.

摘要

引言

胫骨远端移位性关节外骨折的治疗仍存在争议。由于软组织覆盖有限、该区域血运差以及靠近踝关节，这些损伤难以处理。手术治疗选择不断增加，包括锁定髓内钉、钢板螺钉固定和外固定器系统。髓内钉和钢板是英国最常用的选择，但对于哪种治疗在临床和成本效益方面最佳仍存在争议。在这项多中心随机对照试验中，我们旨在评估接受髓内钉或钢板及锁定螺钉固定治疗的胫骨远端骨折患者伤后6个月的残疾评定情况。

方法与分析

在试验中心就诊的急性胫骨远端骨折成年患者将被纳入研究。总共320名患者将有90%的把握度在5%的水平上检测出6个月时残疾评定指数（DRI）评分相差8分。随机分组序列按试验中心和年龄分层，并通过基于网络的服务进行1:1治疗分配。将使用DRI、奥勒鲁德和莫兰德以及欧洲五维健康量表（EQ - 5D）问卷收集基线人口统计学和伤前功能数据及X线片。在6 - 8周时记录临床评估、早期并发症及X线片情况。术后3、6和12个月收集功能结局、健康相关生活质量及资源使用情况。主要分析将在意向性治疗基础上研究两个治疗组术后6个月DRI的差异。检验将采用双侧检验，如果p值<0.05，则认为有显著差异的证据。