一项多中心、随机、平行组、优效性研究，旨在比较外固定架与锁定钢板内固定治疗成人完全关节面Pilon骨折的临床有效性和成本效益。
A multicentre, randomized, parallel group, superiority study to compare the clinical effectiveness and cost-effectiveness of external frame versus internal locking plate for complete articular pilon fracture fixation in adults.
作者信息
Flett Lydia, Adamson Joy, Barron Elizabeth, Brealey Stephen, Corbacho Belen, Costa Matthew L, Gedney Graham, Giotakis Nikolaos, Hewitt Catherine, Hugill-Jones Jessica, Hukins Deborah, Keding Ada, McDaid Catriona, Mitchell Alex, Northgraves Matthew, O'Carroll Grace, Parker Adwoa, Scantlebury Arabella, Stobbart Lynne, Torgerson David, Turner Emma, Welch Charlie, Sharma Hemant
机构信息
York Trials Unit, Department of Health Sciences, University of York, York, UK.
Department of Trauma and Orthopaedics, Hull University Teaching Hospitals NHS Trust, Hull, UK.
出版信息
Bone Jt Open. 2021 Mar;2(3):150-163. doi: 10.1302/2633-1462.23.BJO-2020-0178.
AIMS
A pilon fracture is a severe ankle joint injury caused by high-energy trauma, typically affecting men of working age. Although relatively uncommon (5% to 7% of all tibial fractures), this injury causes among the worst functional and health outcomes of any skeletal injury, with a high risk of serious complications and long-term disability, and with devastating consequences on patients' quality of life and financial prospects. Robust evidence to guide treatment is currently lacking. This study aims to evaluate the clinical and cost-effectiveness of two surgical interventions that are most commonly used to treat pilon fractures.
METHODS
A randomized controlled trial (RCT) of 334 adult patients diagnosed with a closed type C pilon fracture will be conducted. Internal locking plate fixation will be compared with external frame fixation. The primary outcome and endpoint will be the Disability Rating Index (a patient self-reported assessment of physical disability) at 12 months. This will also be measured at baseline, three, six, and 24 months after randomization. Secondary outcomes include the Olerud and Molander Ankle Score (OMAS), the five-level EuroQol five-dimenison score (EQ-5D-5L), complications (including bone healing), resource use, work impact, and patient treatment preference. The acceptability of the treatments and study design to patients and health care professionals will be explored through qualitative methods.
DISCUSSION
The two treatments being compared are the most commonly used for this injury, however there is uncertainty over which is most clinically and cost-effective. The Articular Pilon Fracture (ACTIVE) Trial is a sufficiently powered and rigorously designed study to inform clinical decisions for the treatment of adults with this injury. Cite this article: 2021;2(3):150-163.
目的
Pilon骨折是一种由高能创伤导致的严重踝关节损伤，通常影响劳动年龄的男性。尽管相对不常见（占所有胫骨骨折的5%至7%），但这种损伤导致的功能和健康后果是所有骨骼损伤中最严重的之一，严重并发症和长期残疾风险高，对患者的生活质量和经济前景造成毁灭性影响。目前缺乏指导治疗的有力证据。本研究旨在评估两种最常用于治疗Pilon骨折的手术干预措施的临床效果和成本效益。
方法
将对334例诊断为闭合性C型Pilon骨折的成年患者进行一项随机对照试验（RCT）。将内固定钢板固定与外固定架固定进行比较。主要结局和终点将是12个月时的残疾评定指数（患者自我报告的身体残疾评估）。在随机分组后的基线、3个月、6个月和24个月时也将进行测量。次要结局包括Olerud和Molander踝关节评分（OMAS）、五级欧洲五维健康量表评分（EQ-5D-5L）、并发症（包括骨愈合）、资源使用、工作影响和患者治疗偏好。将通过定性方法探讨患者和医疗保健专业人员对治疗方法和研究设计的可接受性。
讨论
所比较的两种治疗方法是针对这种损伤最常用的方法，但在哪种方法在临床和成本效益方面最佳尚存在不确定性。关节Pilon骨折（ACTIVE）试验是一项样本量充足且设计严谨的研究，可为治疗成年患者这种损伤的临床决策提供依据。引用本文：2021；2(3)：150 - 163。
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