文献速递儿科急症创伤与烧伤

学步儿骨折：可拆卸步行靴 vs 石膏固定的随机对照试验

Casting Doubt on Tradition: Boot vs Cast for Toddler’s Fractures

RSS 订阅 · REBEL EM · 2026-08-10

一句话结论对于有影像学证实的学步儿骨折，可拆卸步行靴治疗在4周疼痛控制方面非劣于石膏固定，且患儿功能恢复更快、照护者负担更轻。

这是一项纳入129名1-4岁学步儿骨折患儿的多中心非劣效随机对照试验，比较可拆卸步行靴（65例）与传统石膏固定（64例）的疗效。主要终点为4周时EVENDOL疼痛评分，靴组为1.23±1.54，石膏组为1.84±2.19，差值-0.61（95%CI -1.31至0.19），符合非劣效标准。靴组77%患儿恢复基线活动水平，石膏组仅41%。靴组在洗澡（41% vs 73%困难）和抱患儿（44% vs 65%困难）方面照护者负担更轻。靴组皮肤并发症发生率72%，石膏组50%，但92%为轻度红斑。研究支持对无复杂情况的学步儿骨折使用可拆卸步行靴替代常规石膏固定。

要点

对于影像学证实的学步儿骨折（胫骨远端2/3、移位<2mm、能负重），可拆卸步行靴治疗4周疼痛控制非劣于石膏固定（EVENDOL评分差值-0.61，95%CI -1.31至0.19）
靴组77%患儿4周时恢复基线活动水平，石膏组仅41%，靴组患儿功能恢复快36%
靴组照护者负担更轻：洗澡困难率41% vs 石膏组73%，抱患儿困难率44% vs 石膏组65%
靴组皮肤并发症发生率72%高于石膏组50%（差值22%，95%CI -6至50%），但92%为轻度红斑，仅8%为压疮
靴组治疗方案为：第1周持续穿戴，之后由照护者根据症状决定是否继续使用，无需常规骨科随访

适用人群与场景

纳入标准：1-4岁儿童，影像学可见的学步儿骨折（胫骨远端2/3螺旋或斜形骨折），移位<2mm，能够负重
排除标准：病理性骨折，延迟就诊（>5天），病理性骨折或骨折愈合延迟高风险患者
研究人群：129名患儿，平均年龄2.2岁，来自4家加拿大三级儿科急诊科

诊断标准与关键阈值

学步儿骨折诊断：胫骨远端2/3螺旋或斜形不移位骨折，影像学表现为穿过胫骨远端的细斜线，内斜位X线片显示最清楚
纳入骨折标准：影像学可见骨折线，移位<2mm，位于胫骨远端2/3，患儿能够负重

处置流程与药物剂量

可拆卸步行靴方案：使用膝下预制步行靴，第1周持续穿戴，之后由照护者根据症状自行决定是否继续使用
传统石膏固定方案：环形石膏（短腿或长腿）固定3周，需骨科随访
靴组治疗无需常规骨科随访，由照护者根据患儿症状调整靴的使用

红旗征与不能漏的情况

使用步行靴时需指导家长监测皮肤刺激、红斑或压疮，靴组皮肤并发症发生率72%
靴组治疗方案要求照护者能够监测皮肤、正确拆卸和重新穿戴步行靴、症状加重时及时就诊

研究设计与关键结果

多中心评估者设盲非劣效随机对照试验，4家加拿大三级儿科急诊科，2019年10月至2024年2月入组129名患儿（平均年龄2.2岁）
主要终点EVENDOL疼痛评分（0-15分）：靴组1.23±1.54，石膏组1.84±2.19，差值-0.61（95%CI -1.31至0.19），达到非劣效标准
次要终点-恢复基线活动：靴组77% vs 石膏组41%，靴组增加36%
次要终点-皮肤并发症：靴组72% vs 石膏组50%，差值22%（95%CI -6至50%），73例皮肤并发症中67例（92%）为轻度红斑，6例（8%）为压疮
次要终点-照护者负担：洗澡困难靴组41% vs 石膏组73%，抱患儿困难靴组44% vs 石膏组65%
随访完成率：靴组99%（1例失访），石膏组84%（10例失访）

证据类型、等级与局限

证据类型：多中心随机对照非劣效试验，评估者设盲
局限性：家属和治疗医生未设盲，存在主观终点报告偏倚风险
局限性：样本量小（129例），未能检测罕见事件如移位、愈合延迟、再骨折或步态问题
局限性：主要终点随访时间短（4周），12周电话随访，对长期骨科结果的信心有限
局限性：EVENDOL疼痛评分依赖观察和照护者判断，学龄前儿童疼痛评估存在主观性

对床旁实践的改变

对于影像学证实、移位<2mm、能负重的学步儿骨折，可在急诊科直接使用可拆卸步行靴替代传统石膏固定，无需常规骨科转诊
步行靴治疗第1周需持续穿戴，之后可由照护者根据患儿症状自行调整使用，减少随访负担
使用步行靴前需评估照护者是否能够监测皮肤、正确使用靴、并在症状加重时及时就诊
需向家长说明步行靴可能增加皮肤红斑风险（72% vs 50%），但多为轻度，需定期检查皮肤
不适用于：病理性骨折、延迟就诊>5天、有骨折愈合延迟高风险、移位≥2mm或不能负重的患儿

指南或共识出处

Boutin A, Colaco K, Stimec J, et al. Removable boot vs casting of toddler's fractures: a randomized clinical trial. JAMA Pediatrics. 2025;179(7):713-721. PMID: 40257790

以上提炼依据论文摘要（全文未开放获取，或许可不允许翻译转载）；全文请点「阅读原文」。

原文图文 · 图 28 张

REBEL Rundown

Key Points

Boot is reasonable: For uncomplicated, radiographically confirmed toddler’s fractures, use a removable walking boot instead of routine casting.

Pain outcomes were similar: Boot treatment was noninferior to casting for pain at 4 weeks.

Kids recovered function faster: More children in the boot group returned to baseline activity compared with the cast group.

Less caregiver burden: Boots made bathing and carrying the child easier than casting.

Check the skin: Counsel parents to monitor for irritation, erythema, or pressure sores.

Introduction

A toddler’s fracture is a spiral or oblique nondisplaced fracture of the distal tibia that most commonly occurs in children 1–4 years of age. The physical findings and radiological appearance are often subtle, consisting of a faint oblique line crossing the distal tibia, best visualized on the internal oblique radiograph.1 The annual incidence of fractures in children under two years of age ranges from 5.3 to 9.5 per 1,000, with Tibia and fibula fractures (one of the most common pediatric fractures) accounting for 17.3% to 27.6% of all fractures in this age group.2 Toddler’s fractures are considered stable fractures with excellent healing potential due to the thick periosteum and inherent stability of the tibia at this age. Although once thought to be associated with non-accidental trauma, subsequent studies have shown that an isolated toddler’s fracture is an expected accidental injury pattern in ambulatory young children.

Traditional management typically involves 3 to 4 weeks of circumferential casting and orthopedic follow-up. Protocols vary by institution, but most include either a long-leg or short-leg cast for immobilization. However, emerging evidence suggests that less restrictive approaches—such as removable walking boots, splints, or even observation—may yield comparable outcomes with fewer complications and less caregiver burden. Additional high-quality studies can help to elucidate the optimal management approach.

Paper

Boutin A, Colaco K, Stimec J, et al. Removable boot vs casting of toddler’s fractures: a randomized clinical trial. JAMA Pediatrics. 2025;179(7):713-721. PMID: 40257790

What They Did

CLINICAL QUESTION

In children aged 1–4 years with radiograph-confirmed toddler’s fracture, is treatment with a removable walking boot without routine orthopedic follow-up noninferior to circumferential casting with respect to pain and functional recovery at 4 weeks?

STUDY DESIGN

Noninferiority multicenter assessor-blinded randomized controlled trial

Four Canadian tertiary Pediatric Emergency Departments

Enrollment period from October 2019 – February 2024

Participants: 129 children (Mean age 2.2 years)

POPULATION

Inclusion Criteria:

Able to bear weight, radiographic visible fracture, <2mm of displacement, fracture present in distal ⅔ of the tibia

Exclusion Criteria:

Pathologic fractures, delayed presentation (>5 days), patients with increased risk for pathologic fractures or delayed healing

INTERVENTION & COMPARATOR

Intervention:

Prefabricated below-knee walking boot that remained in place for 1 week, then as needed based on symptoms (at discretion of parent/caregiver)

Comparator:

Standard of care: Circumferential cast (either short or long leg) applied for three weeks with Orthopedic follow-up

OUTCOMES

Primary OutcomeSecondary Outcomes

Pain at 4 weeks measured by Evaluation Enfant Douleur (EVENDOL) scale (0–15)

Return to baseline activity, caregiver satisfaction, caregiver burden, unscheduled health care visits, and treatment-related complications

Results

RESULTS

A total of 129 patients were enrolled, with 65 randomized to the boot group and 64 to the cast group. One patient was lost to follow-up in the boot group (99% follow-up), and 10 patients were lost in the cast group (84% follow-up).

Primary outcome (EVENDOL pain score, per protocol analysis)Cast: 1.84 +/- 2.19

Boot: 1.23 +/- 1.54

Difference: -0.61 (95% CI −1.31 to 0.19)

Secondary outcomes / adverse eventsReturn to baseline activities as reported by caregiverCast: 41%

Boot: 77%

36% increase in return to baseline in the boot group

Skin complications, defined as either skin rash, erythema, or pressure sores Cast: 50%

Boot: 72%

Increase in 22% (95% CI -6 to 50%). Not statistically significant, but may be clinically significant.

In the 73 patients with skin complications, 67 patients (92%) reported mild erythema, and 6 patients reported a pressure sore (8%).

Caregiver burdenBathing difficulty: 73% cast vs 41% boot

Carrying child: 65% cast vs 44% boot

There was an overall improvement in both categories with boot application vs traditional casting

Caregiver satisfaction No significant difference

Critical Results

Strengths

Randomized multicenter design: Randomization across four tertiary pediatric EDs improves internal validity and reduces the likelihood that institutional practice patterns drove the results.

Clinically relevant noninferiority question: The trial asks a practical ED-facing question: whether a less restrictive, removable boot strategy can safely replace routine casting and orthopedic follow-up for uncomplicated toddler’s fractures.

Appropriate use of both intention-to-treat and per-protocol analyses: Reporting both analyses strengthens interpretation in a noninferiority trial, where protocol deviations and nonadherence can influence conclusions.

Prespecified noninferiority margin: The investigators clearly defined a 2-point EVENDOL pain margin, allowing readers to judge whether the accepted difference was clinically reasonable.

Blinded outcome assessment: Although families could not be blinded, the primary 4-week assessment was performed by a blinded assessor, reducing ascertainment bias for the primary outcome.

High follow-up for the primary outcome overall: Primary outcome follow-up was strong, with only one patient lost in the boot group and 10 lost in the cast group.

Patient- and caregiver-centered outcomes: The study went beyond radiographic healing and included pain, return to baseline activity, caregiver burden, satisfaction, unscheduled visits, and complications.

Pragmatic intervention: Caregiver-directed boot use after the first week reflects real-world practice and makes the results easier to apply in the ED.

Radiograph-confirmed fractures: Limiting enrollment to visible toddler’s fractures improves diagnostic certainty and avoids mixing occult injuries or alternative causes of limp into the study population.

Limitations

Families and treating clinicians were not blinded: This creates risk of reporting bias for subjective outcomes such as pain, activity level, caregiver burden, satisfaction, and skin irritation.

Differential loss to follow-up: Follow-up was excellent in the boot group but lower in the cast group. This matters because unequal attrition can bias noninferiority results, particularly when outcome data are subjective.

Small sample size: With only 129 enrolled patients, the trial was not powered to detect rare but important events such as displacement, delayed healing, refracture, or clinically meaningful gait problems.

Short primary follow-up window: The primary outcome was assessed at 4 weeks, with phone follow-up at 12 weeks. This is reasonable for pain recovery but limits confidence about uncommon longer-term orthopedic outcomes.

Subjective primary outcome: EVENDOL is validated, but pain scoring in preverbal or minimally verbal children still depends on observation and caregiver interpretation.

Skin complications require careful interpretation: Skin issues were numerically more common in the boot group, although most were mild erythema. This may reflect removable device fit, sock/stockinette use, caregiver checks, or reporting differences.

Caregiver-directed treatment may not work equally well for all families: The boot strategy assumes caregivers can monitor skin, remove and reapply the boot appropriately, and return for care if symptoms worsen.

Limited generalizability outside pediatric tertiary EDs: Results may differ in community EDs, urgent care settings, or systems without ready access to appropriately sized pediatric walking boots.

Only uncomplicated, radiographically visible fractures were studied: These findings should not be extended to displaced fractures, proximal tibial fractures, pathologic fractures, delayed presentations, nonambulatory children, or cases with concern for nonaccidental trauma.

Comparator reflects one version of standard care: The cast group included circumferential casting and orthopedic follow-up, but some centers already use splints, CAM boots, or observation. The trial does not directly compare all less restrictive strategies.

Discussion

Evidence Supporting Less Restrictive Management

This study provides high-quality evidence supporting less restrictive management of radiographically confirmed toddler’s fractures. The findings demonstrate that a removable walking boot without scheduled physician follow-up yields comparable pain outcomes to casting. Additionally, the study reports a decrease in caregiver burden with a removable boot compared to standard treatment. The inclusion of only radiograph-visible fractures enhances the clinical applicability of the results to emergency department practice and helps to reduce error in clinical interpretability.

Noninferiority Design and Interpretation

The statistical analysis was appropriate for a noninferiority framework, with both intention-to-treat and per-protocol analyses performed and a clearly prespecified 2-point EVENDOL margin. Noninferiority trials do not prove two treatments are identical; they ask whether the new strategy is not unacceptably worse than standard care. Here, the confidence interval for pain stayed within the prespecified margin, supporting boot treatment as noninferior to casting. This interpretation should remain limited to uncomplicated, radiographically confirmed toddler’s fractures.

Skin Complications and Generalizability

Although there was a trend toward increased mild skin complications in the boot group, these were largely minor and potentially mitigated with proper sock or stockinette use and routine skin checks. The clinical relevance of minor erythema may vary among caregivers and clinicians, especially given the benefits of a removable boot compared to standard casting. The skin complication rate was not statistically significant, but still an important finding that should be communicated to parents. The study was conducted in tertiary care Canadian pediatric emergency departments; therefore, clinicians should consider the applicability of the findings to their own practice settings, as there are meaningful differences in healthcare delivery between the United States and Canada.

Author's Conclusion

“In this multicenter randomized noninferiority trial of children aged 9 months to 4 years with radiographically confirmed toddler’s fractures, treatment with a removable walking boot was noninferior to circumferential casting with respect to pain at 4 weeks. Children managed with a boot returned to baseline activities sooner and caregivers reported lower care burden, although there was a nonsignificant trend toward more mild skin complications. The findings support a less restrictive, caregiver-directed management strategy with a removable boot and no scheduled physician follow-up for uncomplicated toddler’s fractures.”

Our Conclusion

In children aged 9 months to 4 years with a radiographically confirmed toddler’s tibial fracture, treatment with a removable walking boot is appropriate. Parents should be counseled to monitor for skin irritation, and routine orthopedic follow-up is not necessary.

Clinical Bottom Line

For uncomplicated, radiographically confirmed toddler’s fractures: place the child in a removable walking boot, counsel parents on skin checks, and avoid routine casting or orthopedic follow-up.

FAQ

Can a toddler’s fracture be treated with a boot instead of a cast?

Yes. For uncomplicated, radiographically confirmed toddler’s fractures, a removable walking boot is a reasonable alternative to casting, with similar pain outcomes at 4 weeks.

How long should a toddler fracture boot be worn?

A toddler fracture boot is typically worn until the child is cleared by a specialist or follow-up clinician. Families should follow local orthopedic guidance and avoid stopping immobilization early without clear instructions.

What should parents watch for with a toddler fracture boot?

Parents should monitor for skin irritation, redness, pressure sores, worsening pain, refusal to bear weight, or any concern that the boot does not fit properly.