Non-surgical casting versus surgical reduction for children with severely displaced distal radial fractures (the CRAFFT Study): a multicentre, randomised, controlled non-inferiority trial and economic evaluation.

Despite observational evidence of reliable remodelling with growth in younger children, their alarming radiographic appearance-particularly when completely displaced (off-ended)-has driven routine surgical reduction and fixation.

尽管有观察证据表明年幼儿童在生长过程中可靠的重塑，但其令人担忧的放射学表现——特别是完全移位（端对端）时——已经推动了常规的手术复位和固定。

The Children's Radius Acute Fracture Fixation Trial (CRAFFT) aimed to evaluate the clinical and cost-effectiveness of surgical reduction compared with non-surgical casting.

儿童桡骨急性骨折固定试验（CRAFFT）旨在评估手术复位与非手术石膏固定的临床和成本效益。

Methods

This pragmatic, multicentre, randomised, non-inferiority trial included participants (aged 4-10 years) with a severely displaced distal radial fracture from 49 hospitals in the UK.

这项实用的、多中心的、随机的、非劣效试验包括了来自英国49家医院的参与者（年龄在4-10岁之间），这些参与者都患有严重移位的远端桡骨骨折。

Recruiting centres were secondary or tertiary care hospitals providing acute paediatric trauma care.

招募中心是提供急性儿科创伤护理的二级或三级医院。

Participants were randomly assigned to either non-surgical casting or surgical reduction, using a minimisation algorithm with a random element and stratification factors were centre, age group, fracture location, and displacement severity.

参与者随机分配到非手术性石膏固定或手术复位，使用带有随机元素的最小化算法，并考虑了中心、年龄组、骨折部位和移位严重程度等因素进行分层。

Participants and their parents and carers could not be masked to treatment.

参与者及其父母和护理人员无法对治疗进行盲法处理。

Surgical reduction was performed under general anaesthesia or conscious sedation, to restore anatomical alignment, with fixation permitted at the discretion of the surgeon.

手术减容在全身麻醉或意识镇静下进行，以恢复解剖对齐，是否固定由外科医生自行决定。

Non-surgical care involved immobilisation of the fracture in a plaster cast without general anaesthesia or sedation, and without purposeful manipulation of the fracture position.

非手术治疗包括在没有全身麻醉或镇静的情况下，将骨折固定在石膏模具中，不进行骨折位置的有意操纵。

Immobilisation of the fracture beyond 6 weeks post-randomisation was not recommended.

在随机分组后超过6周的时间内，不建议对骨折进行固定。

The primary outcome was upper limb function at 3 months, measured using the Patient Report Outcomes Measurement System (PROMIS) Upper Extremity Score for Children in the intention-to-treatpopulation, which included all participants in the groups to which they were randomly assigned, irrespective of treatment received.

主要结果是在意向治疗人群中，使用患者报告结果测量系统（PROMIS）儿童上肢评分在3个月时的上肢功能，该评分包括所有随机分配到各组的参与者，无论他们实际接受了何种治疗。

The non-inferiority margin was conservatively set at -2·5 points for the main trial population.

主要试验人群的非劣效性边界保守地设定为-2.5分。

A prespecified subgroup analysis was powered to assess whether non-surgical casting could exclude a larger more clinically relevant margin of -5 points among children with completely off-ended fractures.

预先设定的亚组分析有足够的能力评估非手术石膏固定是否能在完全离端骨折的儿童中排除更大的、更具临床意义的5分差距。

Complications and serious adverse events were summarised in a safety (as-treated) population defined by treatment received.

在根据接受的治疗定义的安全（按治疗处理）人群中，总结了并发症和严重不良事件。

A within-trial economic evaluation was undertaken from the perspective of the UK National Health Service (NHS) and Personal Social Services over a 12-month time period.

进行了为期12个月的试验内经济评估，从英国国家医疗服务体系（NHS）和个人社会服务的角度进行。

The trial was registered with the ISRCTN registry, ISRCTN10931294, recruitment is complete and extended follow-up to 3-years post-randomisation is ongoing.

该试验已在ISRCTN注册，注册号为ISRCTN10931294，招募已完成，目前正在对随机化后3年的随访进行延长。

Results

Between Aug 11, 2020, and May 30, 2024, 1227 children were screened for eligibility across 49 UK hospitals. 477 children were excluded (54 met exclusion criteria and 423 did not enter the study, the majority for lack of clinical or parental equipoise). 750 participants were randomly assigned, 375 to the non-surgical casting group and 375 to the surgical reduction group. 456 (61%) participants were male, 294 (39%) were female, and the median age of participants was 7·9 years (IQR 6·5-9·5). 329 (44%) of the 750 participants had completely off-ended fractures.

在2020年8月11日至2024年5月30日期间，英国49家医院对1227名儿童进行了资格筛查。有477名儿童被排除在外（54名符合排除标准，423名未参与研究，大多数是因为缺乏临床或家长的平衡）。750名参与者被随机分配，375名进入非手术石膏组，375名进入手术复位组。456名（61%）参与者为男性，294名（39%）为女性，参与者中位年龄为7.9岁（四分位数间距6.5-9.5）。750名参与者中有329名（44%）完全骨折。

Primary outcome data were collected from 640 (85%) participants.

主要结果数据从640名（占85%）参与者中收集。

At 3 months post-randomisation, the mean PROMIS Upper Extremity score was 44·9 (SD 8·7) in the non-surgical casting group and 46·6 (8·8) in the surgical reduction group (adjusted mean difference -1·64 [95% CI -2·84 to -0·44]), with the confidence intervalfavouring surgical reduction but extending beyond the prespecified non-inferiority margin of -2·5 points.

随机化后3个月，非手术石膏组的平均PROMIS上肢评分是44·9（标准差8·7），手术复位组的评分为46·6（标准差8·8）（调整后的平均差异为-1·64 [95% CI -2·84至-0·44]），置信区间倾向于手术复位，但超出了预先设定的非劣效性界限-2·5分。

In children with completely off-ended fractures, findings were consistent with non-inferiority against the wider, prespecified margin for this group.

对于完全离端骨折的儿童，研究结果与这一组更广泛的预先设定的非劣效性界限一致。

Most complications within 8 weeks occurred in the surgical reduction group, including pressure damage (n=2), wound infections (n=6), scarring (n=5), and nerve irritation (n=1).

在8周内，大多数并发症发生在手术减压组，包括压疮（n=2），伤口感染（n=6），疤痕（n=5）和神经刺激（n=1）。

During the 12-months of follow-up, refracture occurred in 13 participants (nine after non-surgical casting and four after surgical reduction).

在12个月的随访期间，有13名参与者发生了再骨折（九人在非手术石膏固定后，四人在手术减压后）。

From an NHS and Personal Social Services perspective, non-surgical casting was associated with a significant reduction in mean cost per patient of £1665 (95% CI 1487 to 1843) and a marginal incremental reduction in quality-adjusted life-years (QALYs; -0·023 [95% CI -0·037 to -0·009]).

从国家医疗服务体系（NHS）和个人社会服务的角度来看，非手术固定与每例患者平均成本显著降低£1665（95%置信区间1487至1843）相关，并且在质量调整生命年（QALYs）上仅有边际增量减少（-0.023 [95%置信区间-0.037至-0.009]）。

The probability of non-surgical casting being cost-effective at the £20 000 and £30 000 per QALY threshold was 100%, indicating that the small short-term functional advantage of surgical reduction was not cost-effective.

在每QALY £20,000和£30,000的阈值下，非手术固定具有成本效益的概率为100%，表明手术复位的短期功能优势在成本效益上并不显著。

interpretation

The CRAFFT trial did not demonstrate non-inferiority of non-surgical casting at 3 months against a conservative margin; however, the observed difference in favour of surgical reduction was small, below thresholds that families considered meaningful, and did not persist beyond early recovery.

CRAFFT试验未能证明在3个月时非手术性石膏固定与保守边缘相比的非劣效性；然而，观察到的有利于手术减少的差异很小，低于家庭认为有意义的阈值，并且在早期恢复后并未持续。

Surgical reduction was associated with higher costs, early procedural complications, and only a modest improvement in cosmetic appearance, supporting consideration of a cast-first strategy for most children.

手术减少与更高的成本、早期程序并发症相关，且仅在外观上带来适度改善，这支持了大多数儿童首先考虑石膏固定的策略。

funding

National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (17/22/02) and the NIHR Oxford Biomedical Research Centre.

国家健康与护理研究所(NIHR)健康技术评估计划(17/22/02)和NIHR牛津生物医学研究中心。