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.

Funding

UK National Institute for Health and Care Research.

中文翻译：

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儿童腕部环面骨折的固定（FORCE）：在英国进行的随机对照等效试验

背景

儿童最常见的骨折是腕部环面（带扣）骨折。治疗存在争议，从夹板固定和出院到石膏固定、随访和重复成像。这项研究比较了接受软绷带和立即出院的受影响儿童的疼痛和功能与接受刚性固定和按照治疗中心方案进行随访的儿童的疼痛和功能。

方法

在这项随机对照等效性试验中，我们纳入了来自英国 23 家医院的 965 名患有桡骨远端环面骨折的儿童（4-15 岁）。使用定制的基于网络的随机化软件以 1:1 的比例将儿童随机分配到绷带组或刚性固定组。治疗的临床医生、参与者及其家人不能被掩盖治疗分配。排除标准包括多发伤、伤后36 h以上确诊、无法完成随访。主要结果是使用 Wong-Baker FACES 疼痛评定量表测量随机化后 3 天的疼痛。我们进行了改良的意向治疗和每个方案分析。该试验在 ISRCTN 注册中心注册，ISRCTN13955395。

发现

在 2019 年 1 月 16 日至 2020 年 7 月 13 日期间，965 名儿童被随机分配到一组，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%)是男孩。收集了 908 名 (94%) 参与者的主要结果数据，所有参与者都被纳入改良的意向治疗分析。3 天时的疼痛是相同的，绷带组为 3·21 分 (SD 2·08)，而刚性固定组为 3·14 分 (2·11)。参考预先设定的 1·0 等效边际，意向治疗人群的调整后差异为 –0·10（95% CI –0·37 至 0·17）和–0·06（95% CI –0·34 到 0·21) 在每个协议群体中。

解释

该试验发现，分配给绷带组或刚性固定组的桡骨远端环面骨折儿童 3 天时的疼痛是等效的，在 6 周的随访期间，组间的疼痛或功能没有差异——向上。

资金

英国国家健康与护理研究所。