Mittal Rajat, Harris Ian A, Adie Sam, Naylor Justine M
Orthopaedic Department, Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, South Western Sydney Clinical School, UNSW Australia, Liverpool BC, New South Wales, Australia.
BMJ Open. 2017 Mar 27;7(3):e013298. doi: 10.1136/bmjopen-2016-013298.
Isolated type B ankle fractures with no injury to the medial side are the most common type of ankle fracture.
This study aimed to determine if surgery is superior to non-surgical management for the treatment of these fractures.
A pragmatic, multicentre, single-blinded, combined randomised controlled trial and observational study. Setting Participants between 18 and 65 years with a type B ankle fracture and minimal talar shift were recruited from 22 hospitals in Australia and New Zealand. Participants willing to be randomised were randomly allocated to undergo surgical fixation followed by mobilisation in a walking boot for 6 weeks. Those treated non-surgically were managed in a walking boot for 6 weeks. Participants not willing to be randomised formed the observational cohort. Randomisation stratified by site and using permuted variable blocks was administered centrally. Outcome assessors were blinded for the primary outcomes. Primary outcomes Patient-reported ankle function using the American Academy of Orthopaedic Surgeons Foot and Ankle Outcomes Questionnaire (FAOQ) and the physical component score (PCS) of the SF-12v2 General Health Survey at 12 months postinjury. Primary analysis was intention to treat; the randomised and observational cohorts were analysed separately.
From August 2010 to October 2013, 160 people were randomised (80 surgical and 80 non-surgical); 139 (71 surgical and 68 non-surgical) were analysed as intention to treat. 276 formed the observational cohort (19 surgical and 257 non-surgical); 220 (18 surgical and 202 non-surgical) were analysed. The randomised cohort demonstrated that surgery was not superior to non-surgery for the FAOQ (49.8 vs 53.0; mean difference 3.2 (95% CI 0.4 to 5.9), p=0.028), or the PCS (53.7 vs 53.2; mean difference 0.6 (-2.9 to 1.8), p=0.63). 23 (32%) and 10 (14%) participants had an adverse event in the surgical and non-surgical groups, respectively. Similar results were found in the observational cohort.
Surgery is not superior to non-surgical management for 44-B1 ankle fractures in the short term, and is associated with increased adverse events.
NCT01134094.
单纯B型踝关节骨折且内侧无损伤是最常见的踝关节骨折类型。
本研究旨在确定手术治疗这些骨折是否优于非手术治疗。
一项实用的、多中心、单盲、随机对照试验与观察性研究相结合的研究。地点：从澳大利亚和新西兰的22家医院招募18至65岁、患有B型踝关节骨折且距骨移位最小的参与者。愿意接受随机分组的参与者被随机分配接受手术固定，随后穿着步行靴活动6周。非手术治疗的参与者穿着步行靴治疗6周。不愿意接受随机分组的参与者组成观察队列。随机分组按地点分层并使用置换可变区组进行集中管理。结果评估者对主要结局指标不知情。主要结局指标：使用美国矫形外科医师学会足踝结局问卷（FAOQ）和损伤后12个月时SF-12v2一般健康调查的身体成分评分（PCS）来评估患者报告的踝关节功能。主要分析采用意向性分析；对随机分组队列和观察队列分别进行分析。
2010年8月至2013年10月，160人被随机分组（80例手术组和80例非手术组）；139人（71例手术组和68例非手术组）按意向性分析进行分析。276人组成观察队列（19例手术组和257例非手术组）；220人（18例手术组和202例非手术组）进行分析。随机分组队列显示，在FAOQ方面手术并不优于非手术治疗（49.8对53.0；平均差异3.2（95%CI 0.4至5.9），p=0.028），在PCS方面也无差异（53.7对53.2；平均差异0.6（-2.9至1.8），p=0.63）。手术组和非手术组分别有23例（32%）和10例（14%）参与者发生不良事件。观察队列也得出了类似结果。
对于44-B1型踝关节骨折，短期内手术治疗并不优于非手术治疗，且手术治疗会增加不良事件的发生。
NCT01134094。
