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Toddlers Fractures - Cast Versus Removable Boot

Primary Purpose

Toddler's Fracture

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
LPWB
AKWC
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Toddler's Fracture focused on measuring Cast, Removable device/boot, Immobilization strategy, Emergency Department

Eligibility Criteria

9 Months - 4 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • The Hospital for Sick ChildrenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Fiberglass above-knee walking cast (AKWC)

Landmark Pediatric Walker Boot (LPWB)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Complications
Proportion of complications within four weeks post index ED visit. Complications will be a composite outcome of any of the following: pain, skin irritation, infection, immobilization device fitting issues or breakage, thermal injury, cast saw injury, and protracted limping.
Weight-bearing as per baseline
Proportion of children that weight bear as per pre-injury baseline "most of the time"
Unscheduled visits
Proportion of children with unscheduled visits to a physician for the index injury, measured by parental report and Canadian Institute of Health Information data.
Day-to-day issues
Parental perceptions of challenging issues during the four weeks post-injury will be measured using a five point Likert Scale
Immobilization strategy satisfaction
Proportion of parents who were at least "satisfied" with the treatment device measured on a five point Likert scale

Full Information

First Posted
May 30, 2019
Last Updated
June 8, 2021
Sponsor
The Hospital for Sick Children
Collaborators
Population Services International
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1. Study Identification

Unique Protocol Identification Number
NCT03971448
Brief Title
Toddlers Fractures - Cast Versus Removable Boot
Official Title
Randomized Control Trial of Casting Versus Pediatric Walker-Boot in the Management of Toddler's Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
March 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children
Collaborators
Population Services International

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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: The removable pediatric walking boot will be at least as effective as the walking above-knee cast with respect to pain with ambulation as measured by the EVENDOL scale at four weeks after injury. Research Design: This is a multi-centre, two-arm, non-inferiority randomized control trial. All independently weight-bearing children age 9 months to 4 years who present to the ED within five days of a lower extremity injury/complaint and diagnosed clinically and radiolographically with an accidental TF will be eligible for enrolment. Study participants will be randomly assigned to receive either a removable below knee device or a circumferential walking cast. The main outcome will be pain with ambulation as measured by the EVENDOL pain scale at four weeks. Complications, day-to-day burdens, unscheduled visits will be ascertained, as the impact and satisfaction with the treatment device. Accounting to a maximal 20% drop-off rate, a sample size of 160 participants was calculated to have a power of 90% to identify a difference of 2 with an alpha value of 0.025. About one-third of participants will be recruited at CHU Sainte-Justine (n=54). Relevance: Current practice patterns predominately include treatment with a circumferential cast for several weeks. This type of rigid immobilization is likely unnecessary for such a stable injury. However, the research to date comparing casting with removable devices in children with TF has significant limitations and has not been of sufficient quality to change the immobilization and follow-up practice of TF. Specifically, retrospective design and analyses of data collected for a different purpose is subject to methodological limitations such as bias, missing data, and inconsistent measurement of outcomes. Further, these data have typically been limited to a single site, limiting generalizability. Other research has gathered data using surveys, which is limited by the fact that what physicians say they do does not necessarily represent what they actually do, and hence does not necessarily accurately represent clinical practice or outcomes. Finally, no research to date has considered the perspectives of families who need to care for these injured toddlers at home. Therefore, to secure the confidence of all relevant stakeholders, we need to provide high quality evidence to determine the most effective and convenient management strategy for this common childhood injury. If we can demonstrate that a removable device is at least as safe and effective as a circumferential cast in the treatment of TF, there are likely to be similar benefits for these fractures as it has been found with other minor pediatric fractures (e.g. comfort/convenience, safety, recovery, and cost-effectiveness advantages). As this is a common injury in childhood, the use of a removable device to manage this injury is highly likely to result in lower morbidity and save costs for the health care system and population, and these advantages will also generalize nationally and internationally.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Toddler's Fracture
Keywords
Cast, Removable device/boot, Immobilization strategy, Emergency Department

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Enrolled children will be randomly assigned to either a fiberglass above-knee walking cast (AKWC) or the Landmark Pediatric Walker Boot (LPWB).
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fiberglass above-knee walking cast (AKWC)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Landmark Pediatric Walker Boot (LPWB)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
LPWB
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
AKWC
Intervention Description
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.
Primary Outcome Measure Information:
Title
EValuation ENfant DOuLeur (EVENDOL) pain score at four weeks
Description
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.
Time Frame
4 weeks post injury
Secondary Outcome Measure Information:
Title
Complications
Description
Proportion of complications within four weeks post index ED visit. Complications will be a composite outcome of any of the following: pain, skin irritation, infection, immobilization device fitting issues or breakage, thermal injury, cast saw injury, and protracted limping.
Time Frame
4 and 12 weeks post injury
Title
Weight-bearing as per baseline
Description
Proportion of children that weight bear as per pre-injury baseline "most of the time"
Time Frame
2, 4 and 12 weeks post-injury
Title
Unscheduled visits
Description
Proportion of children with unscheduled visits to a physician for the index injury, measured by parental report and Canadian Institute of Health Information data.
Time Frame
4 weeks post injury
Title
Day-to-day issues
Description
Parental perceptions of challenging issues during the four weeks post-injury will be measured using a five point Likert Scale
Time Frame
4 weeks post injury
Title
Immobilization strategy satisfaction
Description
Proportion of parents who were at least "satisfied" with the treatment device measured on a five point Likert scale
Time Frame
4 weeks post injury

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Months
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kathy Boutis, MD, MSc
Phone
4168138982
Email
kathy.boutis@sickkids.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Ariane Boutin, MD, MSc
Phone
1-5146516157
Email
arianeboutin@gmail.com
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathy Boutis, MD, MSc
Email
kathy.boutis@sickkids.ca

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Toddlers Fractures - Cast Versus Removable Boot

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