近日，英国利物浦大学Daniel C Perry团队比较了严重移位桡骨远端骨折儿童的非手术石膏固定与手术复位的效果。2026年4月8日，《柳叶刀》杂志发表了这一成果。

严重移位的桡骨远端骨折是儿童中最常见且最具争议的损伤之一。尽管观察性证据表明，年幼儿童骨折会随生长而发生可靠的重塑，但其令人担忧的影像学表现——尤其是完全移位（端对端分离）时——推动了常规的手术复位和固定。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相比的临床效果和成本效果。

这项实用性、多中心、随机、非劣效性试验纳入了来自英国49家医院的4-10岁严重移位桡骨远端骨折患儿。招募中心为提供急性儿科创伤救治的二级或三级医院。参与者通过最小化算法（含随机元素）并考虑中心、年龄组、骨折位置和移位严重程度等分层因素，被随机分配至非手术石膏固定组或手术复位组。参与者及其父母/照护者无法对治疗分组设盲。手术复位在全麻或清醒镇静下进行，以恢复解剖对位，是否进行内固定由外科医生自行决定。非手术治疗包括将骨折处置于石膏固定中，不使用全麻或镇静，也不对骨折位置进行有目的的整复。不建议在随机分组后超过6周继续行骨折固定。主要结局是3个月时的上肢功能，通过意向治疗人群中的患者报告结局测量信息系统（PROMIS）儿童上肢评分进行测量，意向治疗人群包括所有被随机分配的参与者，无论实际接受何种治疗。主要试验人群的非劣效界值保守设定为-2.5分。预先指定的亚组分析旨在评估在完全移位骨折儿童中，非手术石膏固定能否排除更宽、更具临床相关性的-5分界值。并发症和严重不良事件按实际治疗的安全性人群进行总结。从英国国家卫生服务体系（NHS）和个人社会服务视角，在12个月时间内进行了试验期内经济学评价。该试验已在ISRCTN注册中心注册（ISRCTN10931294），招募工作已完成，随机分组后为期3年的延长随访正在进行中。

2020年8月11日至2024年5月30日，英国49家医院共筛查了1227名儿童的资格。477名儿童被排除（54名符合排除标准，423名未进入研究）。750名参与者被随机分配，其中375名进入非手术石膏固定组，375名进入手术复位组。456名（61%）参与者为男性，294名（39%）为女性，参与者的中位年龄为7.9岁（IQR 6.5–9.5）。750名参与者中有329名（44%）为完全移位骨折。主要结局数据来自640名（85%）参与者。随机分组后3个月，非手术石膏固定组的平均PROMIS上肢评分为44.9（SD 8.7），手术复位组为46.6（SD 8.8）（校正后平均差–1.64 [95% CI –2.84至–0.44]），置信区间有利于手术复位，但超出了预先设定的–2.5分的非劣效界值。在完全移位骨折儿童中，结果与该组更宽的预先指定界值相比符合非劣效性。8周内的大多数并发症发生在手术复位组，包括压力性损伤（n=2）、伤口感染（n=6）、瘢痕形成（n=5）和神经刺激（n=1）。在12个月的随访期间，13名参与者发生再骨折（9例发生在非手术石膏固定后，4例发生在手术复位后）。从NHS和个人社会服务角度来看，非手术石膏固定与每位患者平均成本显著降低1665英镑（95% CI 1487至1843）相关，同时质量调整寿命年（QALYs）有轻微增量减少（–0.023 [95% CI –0.037至–0.009]）。在每QALY 20,000英镑和30,000英镑的阈值下，非手术石膏固定具有成本效果的概率为100%，表明手术复位的微小短期功能优势并不具有成本效果。

综上，CRAFFT试验未证明在3个月时非手术石膏固定相对于保守界值的非劣效性；然而，观察到的有利于手术复位的差异很小，低于家庭认为有意义的阈值，并且在早期恢复后不再持续。手术复位与更高的成本、早期操作并发症相关，仅在外观改善方面有适度提升，这支持了对大多数儿童优先考虑石膏固定的策略。

附：英文原文

Title: 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

Author: Daniel C Perry, Alex Zimmermann, Juul Achten, Nicolas Nicolaou, David Metcalfe, Daphne Kounali, Mark D Lyttle, Samuel Frempong, Duncan Appelbe, James Mason, Rebecca Kandiyali, Phoebe Gibson, Matthew L Costa, Alexander Aarvold, Mohamed Abdelmonem, Joshua Adamson, James Aird, Muhammad Akhtar, Kahlan Al Kaisi, Mohammad Al-Ashqar, Patrick Aldridge, Kieran Almond, Adnan Alnahhas, Munnan Al-Najjim, Kerry Anderson, Christopher Anthony, James Archer, Antonella Ardolino, Abhishek Arora, Luckshman Bavan, Ian Baxter, Oliver Blocker, Praise Briggs, Charlotte Brown, Kwame Buadooh, Pranai Buddhdev, Simon Carley, Catriona Carpenter, Maria Belen Carsi, Charlene Chin, Qaisar Choudry, Stephen Cooke, Johnathan Craik, Rebecca Critchley, Thomas Crompton, Nev Davies, Tessa Davis, Angie Dempster, Laura Deriu, Vikram Desai, Ana Dias, Ha Phuong Do Le, Sara Dorman, Amr Elkhouly, Daniel Engelke, Owain Evans, Jochen Fischer, William Fletcher, Hossam Fraig, Richard Gadd, Andrew Gaffey, Edwina Gamble, Sharryn Gardner, William Timothy Gardner, Robert Gaskell, Yael Gelfer, Akintunde George, Joaquim Goffin, Matthew Hague, Louis Hainsworth, Usman Halim, Beverley Hammond, Emma-Louise Hardean

Issue&Volume: 2026-04-08

Abstract:

Background

Severely displaced distal radial fractures are among the most common and controversial injuries in children. 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. 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.

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. Recruiting centres were secondary or tertiary care hospitals providing acute paediatric trauma care. 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. Participants and their parents and carers could not be masked to treatment. Surgical reduction was performed under general anaesthesia or conscious sedation, to restore anatomical alignment, with fixation permitted at the discretion of the surgeon. 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. Immobilisation of the fracture beyond 6 weeks post-randomisation was not recommended. 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-treat population, which included all participants in the groups to which they were randomly assigned, irrespective of treatment received. The non-inferiority margin was conservatively set at –2·5 points for the main trial population. 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. Complications and serious adverse events were summarised in a safety (as-treated) population defined by treatment received. 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. The trial was registered with the ISRCTN registry, ISRCTN10931294, recruitment is complete and extended follow-up to 3-years post-randomisation is ongoing.

Findings

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. Primary outcome data were collected from 640 (85%) participants. 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 interval favouring surgical reduction but extending beyond the prespecified non-inferiority margin of –2·5 points. In children with completely off-ended fractures, findings were consistent with non-inferiority against the wider, prespecified margin for this group. 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). During the 12-months of follow-up, refracture occurred in 13 participants (nine after non-surgical casting and four after surgical reduction). 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]). The probability of non-surgical casting being cost-effective at the ￡20000 and ￡30000 per QALY threshold was 100%, indicating that the small short-term functional advantage of surgical reduction was not cost-effective.

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. 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.

DOI: 10.1016/S0140-6736(26)00409-5

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(26)00409-5/abstract