Marson Ben A, Gurney Matilda, Manning Joseph C, James Marilyn, Ogollah Reuben, Durand Charlotte, Ollivere Benjamin J
Musculoskeletal, Surgery, Inflammation and Recovery Theme, NIHR Biomedical Research Centre, Nottingham, UK.
Academic Unit of Injury, Recovery and Inflammation Sciences, University of Nottingham, Nottingham, UK.
Bone Joint J. 2025 Jan 1;107-B(1):108-117. doi: 10.1302/0301-620X.107B1.BJJ-2024-0354.R1.
It is unclear if a supportive bandage, removable splint, or walking cast offers the best outcome following low-risk ankle fractures in children. The aim of this study was to evaluate the feasibility of a randomized controlled trial to compare these treatments.
Children aged five to 15 years with low-risk ankle fractures were recruited to this feasibility trial from 1 February 2020 to 30 March 2023. Children were randomized to supportive bandage, removable splint, or walking cast for two weeks. Follow-up at two, six, and 12 weeks was undertaken to determine feasibility for a definitive trial. Outcomes collected included complications, the Patient-Reported Outcomes Measurement Information System (PROMIS) mobility score, Paediatric Quality of Life Inventory, youth version of the EuroQol five-dimension health questionnaire, and Activities Scale for Kids - Performance.
A total of 87 children from six hospitals were randomized at a rate of 0.9 participants per site per month. Two children in the supportive bandage group crossed over to an alternative device. Complications were reported in six children. One child in the cast group developed skin blisters. One child in cast and one in bandage sustained a reinjury during the 12-week follow-up, and two children (one splint and one cast) required additional immobilization after the two-week treatment for persistent pain. Of the 84 participants who remained in the study at six weeks, 43 (51.2%) returned follow-up questionnaires at six weeks. Of the patient-reported outcome measures (PROMs), proxy-reported PROMIS mobility showed good responsiveness, low ceiling effects, and low missing item rates. In an exploratory analysis, small differences were observed between groups, with no evidence that any of the treatments were superior.
This feasibility study showed acceptable recruitment and retention rates. There remains equipoise regarding the best treatment of these injuries. All three treatments appear well tolerated with similar complication rates. A primary outcome of complications or treatment failure would provide the highest study retention with secondary PROMs and economic analysis.
对于儿童低风险踝关节骨折，尚不清楚使用支撑绷带、可拆除夹板或行走石膏哪种治疗效果最佳。本研究的目的是评估一项比较这些治疗方法的随机对照试验的可行性。
2020年2月1日至2023年3月30日，招募5至15岁患有低风险踝关节骨折的儿童参加这项可行性试验。将儿童随机分为支撑绷带组、可拆除夹板组或行走石膏组，为期两周。在第2、6和12周进行随访，以确定确定性试验的可行性。收集的结果包括并发症、患者报告结局测量信息系统（PROMIS）活动能力评分、儿童生活质量量表、青少年版欧洲五维健康问卷以及儿童活动量表-表现。
来自六家医院的87名儿童被随机分组，每个站点每月的随机分配率为0.9名参与者。支撑绷带组有两名儿童改用了其他装置。有六名儿童报告了并发症。石膏组有一名儿童出现皮肤水泡。在12周的随访期间，石膏组和绷带组各有一名儿童再次受伤，两名儿童（一名夹板组和一名石膏组）在两周治疗后因持续疼痛需要额外固定。在六周时仍留在研究中的84名参与者中，有43名（51.2%）在六周时返回了随访问卷。在患者报告结局指标（PROMs）中，代理报告的PROMIS活动能力显示出良好的反应性、低天花板效应和低缺失项率。在探索性分析中，各组之间观察到细微差异，但没有证据表明任何一种治疗方法更优。
这项可行性研究显示了可接受的招募和保留率。对于这些损伤的最佳治疗方法仍存在不确定性。所有三种治疗方法的耐受性似乎都良好，并发症发生率相似。以并发症或治疗失败作为主要结局将使研究保留率最高，并进行次要PROMs和经济分析。
