英国牛津大学Daniel C Perry团队比较了两种儿童腕关节骨折固定术的疗效。2022年7月2日出版的《柳叶刀》杂志发表了这项成果。
儿童最常见的骨折是腕关节环（扣）骨折。治疗方法存在争议，从夹板固定至出院到石膏固定、随访和重复成像。研究组比较了使用软绷带并立即出院的受影响儿童与接受刚性固定儿童的疼痛程度和功能，并根据治疗中心方案进行随访。
在这项随机对照、等效试验中，研究组纳入来自英国23家医院的965名患有桡骨远端环骨折的儿童（年龄4-15岁）。使用定制的基于网络的随机软件，将儿童按1:1的比例随机分配至绷带组或刚性固定组。治疗临床医生、参与者及其家人在治疗分配中不双盲。排除标准包括多发伤、伤后36小时以上诊断和无法完成随访。主要结局是使用Wong-Baker FACES疼痛评定量表测评随机化后3天的疼痛程度。研究组进行了改良意向治疗分析和按方案分析。
2019年1月16日至2020年7月13日，共965名儿童被随机分配，其中489名被分配到绷带组，476名被分配到刚性固定组；379名（39%）为女孩，586名（61%）为男孩。共收集了908名参与者（94%）的主要结局数据，所有参与者均被纳入改良意向治疗分析。在第3天，绷带组的疼痛程度相当于3.21分，而刚性固定组的疼痛程度相当于3.14分。参考预先指定的等效边缘1.0，按治疗意向分析和按方案分析人群的校正差异分别为-0.10和-0.06。
研究结果表明，在6周的随访期间，分配给绷带组或刚性固定组的桡骨远端骨折儿童在3天时的疼痛程度相当，组间疼痛或功能没有差异。
附：英文原文
Title: Immobilisation of torus fractures of the wrist in children (FORCE): a randomised controlled equivalence trial in the UK
Author: Daniel C Perry, Juul Achten, Ruth Knight, Duncan Appelbe, Susan J Dutton, Melina Dritsaki, James M Mason, Damian T Roland, Shrouk Messahel, James Widnall, Matthew L Costa, Rahail Ahmad, Anastasia Alcock, Andy Appelboam, Lisa Armour, Jane Bayreuther, Rhys Beynon, Charlotte Brown, Emily Cadman, Nadine Darlow, Tessa Davis, Colin Gilhooley, Sylvester Gomes, Christopher Gough, David Hartin, Stuart Hartshorn, Temem (Tim) Hussan, Neha Jain, Emma Jenkinson, Graham Johnson, Lisa Kehler, Matt Long, Mark Lyttle, Shahab Manouchehri, Christopher McKie, David Metcalfe, Louise Morgans, Niall Mullen, Alex Novak, Catherine Nunn, Kath OHagan, Aman Paul, Shammi Ramlakhan, Aarani Somaskanthan, Yok Weng Tan, Manish Thakker, Krishna Vemulapalli, Joanna Weekes, Dan Westacott, Sarah Wilson, Darryl Wood
Issue&Volume: 2022/07/02
Abstract:
Background
The most common fractures in children are torus (buckle) fractures of the wrist. Controversy exists over treatment, which ranges from splint immobilisation and discharge to cast immobilisation, follow-up, and repeat imaging. This study compared pain and function in affected children offered a soft bandage and immediate discharge with those receiving rigid immobilisation and follow-up as per treating centre protocol.
Methods
In this randomised controlled equivalence trial we included 965 children (aged 4–15 years) with a distal radius torus fracture from 23 hospitals in the UK. Children were randomly allocated in a 1:1 ratio to the offer of bandage group or rigid immobilisation group using bespoke web-based randomisation software. Treating clinicians, participants, and their families could not be masked to treatment allocation. Exclusion criteria included multiple injuries, diagnosis at more than 36 h after injury, and inability to complete follow-up. The primary outcome was pain at 3-days post-randomisation measured using Wong-Baker FACES Pain Rating Scale. We performed a modified intention-to-treat and per protocol analysis. The trial was registered with ISRCTN registry, ISRCTN13955395.
Findings
Between Jan 16, 2019, and July 13, 2020, 965 children were randomly allocated to a group, 489 to the offer of a bandage group and 476 to the rigid immobilisation group, 379 (39%) were girls and 586 (61%) were boys. Primary outcome data was collected for 908 (94%) of participants, all of whom were included in the modified intention-to-treat analysis. Pain was equivalent at 3 days with 3·21 points (SD 2·08) in the offer of bandage group versus 3·14 points (2·11) in the rigid immobilisation group. With reference to a prespecified equivalence margin of 1·0, the adjusted difference in the intention-to-treat population was –0·10 (95% CI –0·37 to 0·17) and–0·06 (95% CI –0·34 to 0·21) in the per-protocol population.
Interpretation
This trial found equivalence in pain at 3 days in children with a torus fracture of the distal radius assigned to the offer of a bandage group or the rigid immobilisation group, with no between-group differences in pain or function during the 6 weeks of follow-up.
DOI: 10.1016/S0140-6736(22)01015-7
Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)01015-7/fulltext
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本期文章：《柳叶刀》：Volume 400 Number 10345
