Surgical fixation versus non-surgical care for children with a displaced medial epicondyle fracture of the elbow (the SCIENCE study): a multicentre, randomised controlled, superiority trial and economic evaluation.

Approximately half of affected children undergo surgical fixation, while others receive non-surgical care.

大约一半受影响的儿童接受手术固定，而其他人则接受非手术治疗。

The SCIENCE trial aimed to determine whether surgical fixation to restore the position of the bone provides superior functional outcomes and is cost-effective compared with non-surgical care.

SCIENCE试验旨在确定通过手术固定恢复骨骼位置是否能带来更佳的功能性结果，并且与非手术治疗相比是否更具有成本效益。

Methods

We conducted a pragmatic multicentre, randomised, superiority trial across 59 hospitals in the UK, Australia, and New Zealand.

我们在英国、澳大利亚和新西兰的59家医院开展了一项实用的多中心、随机、优效试验。

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

招募地点为提供急性儿童创伤护理的二级或三级医院。

Eligible participants were aged 7-15 years with a displaced medial epicondyle fracture and patients were excluded if the injury occurred more than 2 weeks prior, they had a medial epicondyle fragment that was incarcerated (trapped) within the joint, the injury was part of a complex elbow fracture (ie, extending into the joint), or there were additional fractured bones outside of the elbow.

符合条件的参与者年龄为7-15岁，患有移位的内上髁骨折，如果受伤时间超过2周，或者内上髁碎片被关节内卡住，或者损伤是复杂的肘部骨折的一部分（即延伸到关节内），或者肘部以外有其他骨折，则被排除在外。

Participants were randomly assigned (1:1) to either surgical fixation or non-surgical care using a web-based randomisation software from Oxford Clinical Trials Research Unit, with minimisation (including a random element) stratified by centre and elbow dislocation status at presentation.

参与者通过牛津临床试验研究中心的基于网络的随机化软件以1:1的比例随机分配到手术固定组或非手术治疗组，采用包括随机元素的最小化方法按中心和就诊时肘关节脱位状态进行分层。

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 fixation was performed under general anaesthesia and involved a surgical incision, restoration of the anatomical alignment, and fixing the fragment, typically with a screw or wires.

手术固定是在全身麻醉下进行的，包括手术切口、恢复解剖对齐以及使用螺钉或线材固定碎片。

Non-surgical care involved immobilisation of the elbow at approximately 90° of flexion using a cast, splint, or sling.

非手术治疗涉及使用石膏、夹板或吊带将肘部固定在大约90度的屈曲位置。

Both groups were allowed mobilisation as pain allowed, although cast immobilisation beyond 4 weeks was discouraged.

两组患者均允许根据疼痛情况活动，但不鼓励超过4周的石膏固定。

The primary outcome was upper limb function at 12 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12个月时的上肢功能，使用患者报告结果测量系统（PROMIS）儿童上肢评分进行测量，该评分针对意向治疗人群，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。

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

并发症和严重不良事件在一个由所接受治疗定义的安全性（按治疗处理）人群中进行了总结。

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

在12个月的时间范围内，从英国国家医疗服务体系和个人社会服务的角度进行了一项试验内经济评估。

The trial was registered with ISRCTN, ISRCTN16619778; recruitment is complete and extended follow-up to age 16 years is ongoing.

该试验已在ISRCTN注册，注册号为ISRCTN16619778；招募工作已完成，目前正在进行延长至16岁的随访。

Results

Between June 10, 2019, and Sept 22, 2023, 647 patients from 59 sites met the inclusion criteria. 146 patients were excluded (64 due to the injury being more than 2 weeks old and 24 because the epicondyle fragment was incarcerated within the joint), 161 families of children meeting the eligibility criteria declined to participate, and for five patients there was no clinician equipoise. 335 participants were randomly assigned to an intervention (166 to the non-surgical care group and 168 to the surgical fixation group) and one was immediately excluded due to a randomisation error.

在2019年6月10日至2023年9月22日期间，来自59个地点的647名患者符合纳入标准。由于受伤时间超过2周，有64名患者被排除在外；24名患者因肱骨外上髁碎片嵌入关节内而被排除；161名符合条件的儿童的家庭拒绝参与；有五名患者因临床医生缺乏均衡性而未被纳入。共有335名参与者被随机分配到干预组（166名接受非手术护理，168名接受手术固定），其中一名因随机化错误立即被排除。

Primary outcome data were collected from 285 (85%) participants. 170 (51%) participants were female and 164 (49%) were male.

主要结果数据从285名（85%）参与者中收集。其中170名（51%）为女性，164名（49%）为男性。

Mean participant age at baseline was 11·7 years (SD 2·3).

基线时参与者的平均年龄为11.7岁（标准差2.3）。

At 12 months post-randomisation, the PROMIS Upper Extremity score was 53·1 (SD 7·8) in the non-surgical care group and 54·3 (5·7) in the surgical fixation group (mean treatment difference, 1·57 [95% CI -0·01 to 3·14; p=0·052]).

随机化后12个月，非手术护理组的PROMIS上肢评分是53.1（标准差7.8），手术固定组的评分为54.3（标准差5.7）（平均治疗差异为1.57 [95% 置信区间 -0.01 至 3.14; p=0.052]）。

This estimate of treatment effect was below the clinically important difference specified (4 points), supporting the conclusion that a clinically important effect is unlikely.

这个治疗效果的估计低于指定的临床重要差异（4分），支持这样一个结论：临床上重要的效果不太可能。

Additional episodes of surgery, either planned or related to complications, occurred in 24 participants in the surgical group and three in the non-surgical group.

在手术组中，有24名参与者发生了额外的手术，无论是计划中的还是与并发症相关的，而非手术组中则有3名参与者发生了额外手术。

Among the 150 participants who underwent surgical fixation, there were 14 intraoperative complications from 13 (9%) participants, and seven participants had a postoperative complication (5% participants) each requiring surgery.

在150名接受手术固定的参与者中，有14名术中并发症，来自13名（9%）参与者，另外有7名参与者（占5%）发生了术后并发症，每例均需再次手术。

Routine screw or wire removal was undertaken in a further 17 (11%) participants.

在另外17名（11%）参与者中进行了常规的螺钉或钢丝移除。

From the 184 participants in the non-surgical group, there were five complications among four (2%) participants, three (2%) of which required additional surgery.

在184名非手术组参与者中，有四名（2%）参与者出现了五次并发症，其中三名（2%）需要额外的手术。

The mean per patient cost from the NHS and Personal Social Services perspective was £2435 (95% CI 1812 to 3057) more for participants in the surgical fixation group with a mean per patient quality-adjusted life year difference of -0·008 (95% CI -0·039 to 0·024).

从NHS和私人社会服务的角度来看，外科固定组每位患者的平均成本比对照组高出£2435（95%置信区间1812至3057），每位患者的质量调整生命年差异为-0·008（95%置信区间-0·039至0·024）。

The probability that surgical fixation is cost-effective at the £20 000 or £30 000 per quality-adjusted life year willingness-to-pay threshold was 0%.

在每质量调整生命年支付意愿阈值为£20,000或£30,000的情况下，外科固定治疗具有成本效益的概率为0%。

interpretation

The SCIENCE trial demonstrates that surgical fixation offers no clinical benefit and is not cost-effective compared with non-surgical care, while exposing children to avoidable surgical risks.

SCIENCE试验表明，与非手术治疗相比，手术固定没有临床益处，且成本效益不高，同时使儿童面临不必要的手术风险。

These findings suggest that non-surgical care should be adopted as the default management strategy for these injuries, regardless of initial elbow dislocation status.

这些发现表明，无论初始肘关节脱位状态如何，都应将非手术治疗作为这些损伤的默认管理策略。

funding

National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (17/18/02), with additional support from the NIHR Academy, Oxford NIHR Biomedical Research Centre, and the Starship Foundation (New Zealand).

国家卫生和护理研究(NIHR)健康技术评估计划(17/18/02)，额外支持来自NIHR学院、牛津NIHR生物医学研究中心以及新西兰的Starship基金会。