Oxford Trauma and Emergency Care, Kadoorie Research Centre, Nuffield Department of Orthopaedic, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
Department of Orthopaedic Surgery, Alder Hey Children's NHS Foundation Trust, Liverpool, UK.
Health Technol Assess. 2022 Jul;26(33):1-78. doi: 10.3310/BDNS6122.
Torus (buckle) fractures of the wrist are the most common fractures in children involving the distal radius and/or ulna. It is unclear if children require rigid immobilisation and follow-up or would recover equally as well by being discharged without any immobilisation or a bandage. Given the large number of these injuries, identifying the optimal treatment strategy could have important effects on the child, the number of days of school absence and NHS costs.
To establish whether or not treating children with a distal radius torus fracture with the offer of a soft bandage and immediate discharge (i.e. offer of a bandage) provides the same recovery, in terms of pain, function, complications, acceptability, school absence and resource use, as treatment with rigid immobilisation and follow-up as per usual practice (i.e. rigid immobilisation).
A pragmatic, multicentre, randomised controlled equivalence trial.
Twenty-three UK emergency departments.
A total of 965 children (aged 4-15 years) with a distal radius torus fracture were randomised from January 2019 to July 2020 using a secure, centralised, online-encrypted randomisation service. Exclusion criteria included presentation > 36 hours after injury, multiple injuries and an inability to complete follow-up.
A bandage was offered to 489 participants and applied to 458, and rigid immobilisation was carried out in 476 participants. Participants and clinicians were not blinded to the treatment allocation.
The pain at 3 days post randomisation was measured using the Wong-Baker FACES Pain Rating Scale. Secondary outcomes were the patient-reported outcomes measurement system upper extremity limb score for children, health-related quality of life, complications, school absence, analgesia use and resource use collected up to 6 weeks post randomisation.
A total of 94% of participants provided primary outcome data. At 3 days, the primary outcome of pain was equivalent in both groups. With reference to the prespecified equivalence margin of 1.0, the adjusted difference in the intention-to-treat population was -0.10 (95% confidence interval -0.37 to 0.17) and the per-protocol population was -0.06 (95% confidence interval -0.34 to 0.21). There was equivalence of pain in both age subgroups (i.e. 4-7 years and 8-15 years). There was no difference in the rate of complications, with five complications (1.0%) in the offer of a bandage group and three complications (0.6%) in the rigid immobilisation group. There were no differences between treatment groups in functional recovery, quality of life or school absence at any point during the follow-up. Analgesia use was marginally higher at day 1 in the offer of a bandage group than it was in the rigid immobilisation group (83% vs. 78% of participants), but there was no difference at other time points. The offer of a bandage significantly reduced the cost of treatment and had a high probability of cost-effectiveness at a willingness-to-pay threshold of £30,000 per quality-adjusted life-year.
Families had a strong pre-existing preference for the rigid immobilisation treatment. Given this, and the inability to blind families to the treatment allocation, observer bias was a concern. However, there was clear evidence of equivalence.
The study findings support the offer of a bandage in children with a distal radius torus fracture.
A clinical decision tool to determine which children require radiography is an important next step to prevent overtreatment of minor wrist fractures. There is also a need to rationalise interventions for other common childhood injuries (e.g. 'toddler's fractures' of the tibia).
This trial is registered as ISRCTN13955395 and UKCRN Portfolio 39678.
This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 26, No. 33. See the NIHR Journals Library website for further project information.
腕骨（骨弓）骨折是儿童最常见的涉及桡骨远端和/或尺骨的骨折。目前尚不清楚儿童是否需要刚性固定和随访，或者不固定或不包扎是否同样可以康复。鉴于此类损伤数量众多，确定最佳治疗策略可能会对儿童、缺课天数和 NHS 成本产生重要影响。
确定对于桡骨远端骨弓骨折的儿童，提供软性绷带并立即出院（即提供绷带）是否与常规刚性固定和随访的治疗效果相同，在疼痛、功能、并发症、可接受性、缺课和资源利用方面。
一项实用的、多中心、随机对照等效试验。
23 家英国急诊部门。
共有 965 名 4-15 岁桡骨远端骨弓骨折的儿童于 2019 年 1 月至 2020 年 7 月期间使用安全、集中、在线加密随机化服务进行随机分组。排除标准包括受伤后>36 小时就诊、多处损伤和无法完成随访。
489 名参与者被提供绷带，其中 458 名接受了绷带，476 名接受了刚性固定。参与者和临床医生对治疗分配不知情。
在随机分组后 3 天使用 Wong-Baker FACES 疼痛评分量表测量疼痛。次要结局包括儿童患者报告结局测量系统上肢评分、健康相关生活质量、并发症、缺课、镇痛药物使用和资源利用，直至随机分组后 6 周。
共有 94%的参与者提供了主要结局数据。在第 3 天，疼痛的主要结局在两组之间等效。参照预设的等效边界 1.0，意向治疗人群的调整差异为-0.10（95%置信区间-0.37 至 0.17），协议人群的调整差异为-0.06（95%置信区间-0.34 至 0.21）。在两个年龄亚组（4-7 岁和 8-15 岁）中，疼痛都等效。并发症发生率无差异，提供绷带组有 5 例并发症（1.0%），刚性固定组有 3 例并发症（0.6%）。在随访期间的任何时间点，治疗组之间在功能恢复、生活质量或缺课方面均无差异。在提供绷带组，第一天的镇痛药物使用率略高于刚性固定组（83%vs.78%的参与者），但在其他时间点没有差异。提供绷带显著降低了治疗成本，在愿意支付每质量调整生命年 30000 英镑的意愿支付阈值下具有高度的成本效益。
家庭对刚性固定治疗有强烈的固有偏好。考虑到这一点，以及无法对家庭进行治疗分配的盲法，观察者偏倚是一个关注点。然而，有明确的等效证据。
研究结果支持对桡骨远端骨弓骨折的儿童提供绷带。
确定哪些儿童需要进行 X 光检查的临床决策工具是预防过度治疗儿童腕部小骨折的重要下一步。还需要合理干预其他常见儿童损伤（例如胫骨的“幼儿骨折”）。
该试验在 ISRCTN 注册，编号为 ISRCTN87360129，英国临床试验注册库注册号为 39678。
该项目由英国国家卫生与保健优化研究所（NIHR）健康技术评估计划资助，全文将在 ; Vol. 26, No. 33. 中发表。有关该项目的更多信息，请参见 NIHR 期刊库网站。
