Toddlers Fractures - Cast Versus Removable Boot

NCT03971448 | Completed

• 1 other identifier: 1000063960
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Toddler's Fracture

Keywords

Cast; Removable device/boot; Immobilization strategy; Emergency Department

Outcome Measures

Primary Outcomes (1)

• EValuation ENfant DOuLeur (EVENDOL) pain score at four weeks

  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.

  4 weeks post injury

Secondary Outcomes (5)

• Complications

  4 and 12 weeks post injury

• Weight-bearing as per baseline

  2, 4 and 12 weeks post-injury

• Unscheduled visits

  4 weeks post injury

• Day-to-day issues

  4 weeks post injury

• Immobilization strategy satisfaction

  4 weeks post injury

Study Arms (2)

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.

Device: AKWC

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.

Device: LPWB

Interventions

LPWB DEVICE

The LPWB will be placed by clinical staff who will have been trained on the proper application of this device at the initial ED visit. At ED discharge, both populations will receive identical documentation on recommendations for weight bearing, type and frequency of analgesics, reasons to return for medical attention. The only difference will be care instructions related to the specific immobilization device. Specifically, the experimental group will be permitted to remove the LPWB as early as one week post ED visit as tolerated by the patient's symptoms.

Landmark Pediatric Walker Boot (LPWB)

AKWC DEVICE

If the patient is randomised to AKWC, it will be apply by a cast technician. Children with AKWC immobilization will be provided with up to two appointments in the orthopedic clinic. In case the AKWC could not been placed at initial visit, the first will be within 72 hours of the ED visit to have the fiberglass AKWC placed. The second appointment will be for cast removal.

Fiberglass above-knee walking cast (AKWC)

Eligibility Criteria

• Age: 9 Months - 4 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Population Services International: collaborator

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, Canada

Location

Related Publications (1)

• Boutin A, Colaco K, Stimec J, Camp M, Narayanan U, Bhatt M, Poonai N, Willan AR, Cook R, Nault ML, Carsen S, Boutis K. Removable Boot vs Casting of Toddler's Fractures: A Randomized Clinical Trial. JAMA Pediatr. 2025 Apr 21;179(7):713-21. doi: 10.1001/jamapediatrics.2025.0560. Online ahead of print.

  PMID: 40257790 DERIVED

MeSH Terms

Conditions

Tibial Fractures; Emergencies

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Emergency Physician, Research and PRAISE Director, Sr. Associate Scientist, Child Health Evaluative Sciences, Research Institute, The Hospital for Sick Children

Model Details: Enrolled children will be randomly assigned to either a fiberglass above-knee walking cast (AKWC) or the Landmark Pediatric Walker Boot (LPWB).

Study Record Dates

• First Submitted: May 30, 2019
• First Posted: June 3, 2019
• Study Start: January 1, 2020
• Primary Completion: March 15, 2024
• Study Completion: March 15, 2024
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)