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临床试验/NCT03971448
NCT03971448已完成不适用

Randomized Control Trial of Casting Versus Pediatric Walker-Boot in the Management of Toddler's Fractures

The Hospital for Sick Children1 个研究点 分布在 1 个国家目标入组 129 人开始时间: 2020年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
129
试验地点
1
主要终点
EValuation ENfant DOuLeur (EVENDOL) pain score at four weeks

研究概览

简要总结

A toddler's fracture is a fracture that occurs in the lower leg, oven the shin, of children 9 months to four years of age. It usually happens when a young child twists the leg while running or jumping. It is one of the most common injuries of the leg in this age group. In Canada and the United States there are about 80,000 cases per year that present to emergency departments. The good news is that these fractures are stable injuries and heal exceptionally well, without any reported concerns for problems in the future. Despite this, most children with this fracture are managed in a restrictive full circular cast, often including the entire leg, for three to six weeks. This cast management then also includes about two to three repeat visits to see a bone doctor, where the cast is often changed and new x-rays are taken with each visit. However, none of these things has ever been shown to change the way these young children's fractures heal. Further, casting can cause harm such as skin irritation or poor cast fit which may result in problems that are more distressing than the fracture itself. There are also costs to consider. The needless excess costs of the current management strategy in Canada alone can be estimated to be about 1.8 million dollars annually. And so, increasingly, some doctors are choosing to manage these stable fractures with a supportive device on the lower leg, a removable walking boot. This type of device can be taken off as needed by the parent and child and used only as long as the child needs it to manage the pain that results from this stable fracture. This makes caring for the child much easier and allows the child to return to activities when the child is ready. Further, families do not necessarily need to return to a bone doctor for cast changes or x-rays or reassessment. Since this fracture recovers so well, patients can see their family doctor to make sure their child is returning to activity as expected and have their questions about recovery answered. But, in order to be sure that the removable walking boot works as well as a cast in these fractures, we need to do a well-designed study to make sure we consider all the important aspects of making this change. As a result, in children with toddler's fractures, we will compare the traditional treatment of cast placement to a removable walking boot with respect to how each immobilization strategy controls pain and how quickly children return to their usual activities. We hope that children treated with a removable walking boot will still be able to achieve good pain control while their injury is healing. It is possible too those children will even return to their activities sooner and this newer strategy could save the health care system money.

详细描述

Background:

Toddler's fractures (TF) are characterized as stable, spiral or oblique fractures of the tibial diaphysis or distal metaphysis that mainly occur in children between nine months and four years of age. Despite its inherent stability, the most frequent treatment option remains an above/below knee casting for three to six weeks, without clear and strong evidence to do so. Casting and orthopedic follow-up results in further burden including unnecessary visits to an orthopedic surgeon, additional sets of lower extremity radiographs and day-to-day inconveniences/complications (e.g. bathing/showering, problems of fit, breakage, and skin related complications). Commercially available removable immobilization devices have been applied successfully to low-risk stable extremity pediatric fractures, and have numerous advantages over conventional immobilization with casts (e.g. easy care, comfort and application/removal convenience) but have not properly been studied in the management of TF.

Study Aims:

To compare the recovery of children with TF when treated with a commercial, removable immobilization device versus an above-knee walking fiberglass cast.

Hypothesis:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Double blinding is not feasible since the patient and families will know which immobilization method was applied. Therefore, the individual performing the outcome assessments will be a different person from the research team and will be masked to treatment allocation. The families will be instructed not to reveal the allocation to the research team member in order to minimize the chances of unblinding during follow-up encounters. In spite of the latter, there is potential for accidental unblinding. The frequency of this will be documented and reported.

入排标准

年龄范围
9 Months 至 4 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Otherwise healthy, independently weight-bearing children aged 9 months to 4 years
  • •Present to the ED at SickKids, LHSC or CHU Sainte-Justine within five days of a lower extremity injury
  • •Diagnosed clinically and radiographically with an accidental TF will be eligible for enrolment

排除标准

  • •Children at risk for pathological fractures (Appendix 1) or those with chronic conditions (arthritis or neuromuscular disorders) since these children have different management requirements and potentially different pain and recovery timelines
  • •Children with multi-limb injuries
  • •Children with neuromotor deficits such that assessment of recovery or pain is confounded by the deficits
  • •Children whose parents/guardians who are unable to provide consent or complete follow-up procedures due to an insurmountable language barrier, or no access to a phone or electronic mail
  • •Children with diagnostic uncertainty of a TF (e.g. occult TF) or those whose TF might be the result of non-accidental injury

研究组 & 干预措施

Fiberglass above-knee walking cast (AKWC)

Active Comparator

The standard treatment arm will be a posterior splint placed in the ED by the ED clinical team (nurse/physician) and then a fiberglass AKWC to be placed ideally within 72 hours in the fracture clinic. This AKWC will be in place for 3 weeks, which is currently the most common strategy to manage TF.

干预措施: AKWC (Device)

Landmark Pediatric Walker Boot (LPWB)

Experimental

The Landmark Pediatric Walker Boot (LPWB) will be placed in the ED and will be kept on for a minimum of one week, and then for a duration dictated by the patient's comfort.

干预措施: LPWB (Device)

结局指标

主要结局

EValuation ENfant DOuLeur (EVENDOL) pain score at four weeks

时间窗: 4 weeks post injury

In this scale, there are five items (scored 0 to 3) using two simultaneous criteria (intensity and duration of the behaviour) for a total score that ranges from 0 to 15. Using this measurement, higher scores indicate more pain, and a score of at least four should trigger a clinician to provide pharmacological analgesia.

次要结局

  • Complications(4 and 12 weeks post injury)
  • Unscheduled visits(4 weeks post injury)
  • Weight-bearing as per baseline(2, 4 and 12 weeks post-injury)
  • Day-to-day issues(4 weeks post injury)
  • Immobilization strategy satisfaction(4 weeks post injury)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kathy Boutis

Staff Emergency Physician, Research and PRAISE Director, Sr. Associate Scientist, Child Health Evaluative Sciences, Research Institute, The Hospital for Sick Children

The Hospital for Sick Children

研究点 (1)

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