- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03971448
Toddlers Fractures - Cast Versus Removable Boot
Randomized Control Trial of Casting Versus Pediatric Walker-Boot in the Management of Toddler's Fractures
Study Overview
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kathy Boutis, MD, MSc
- Phone Number: 4168138982
- Email: kathy.boutis@sickkids.ca
Study Contact Backup
- Name: Ariane Boutin, MD, MSc
- Phone Number: 1-5146516157
- Email: arianeboutin@gmail.com
Study Locations
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Ontario
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Toronto, Ontario, Canada
- Recruiting
- The Hospital for Sick Children
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Contact:
- Kathy Boutis, MD, MSc
- Email: kathy.boutis@sickkids.ca
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Fiberglass above-knee walking cast (AKWC)
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.
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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.
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Experimental: Landmark Pediatric Walker Boot (LPWB)
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
EValuation ENfant DOuLeur (EVENDOL) pain score at four weeks
Time Frame: 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.
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4 weeks post injury
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complications
Time Frame: 4 and 12 weeks post injury
|
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.
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4 and 12 weeks post injury
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Weight-bearing as per baseline
Time Frame: 2, 4 and 12 weeks post-injury
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Proportion of children that weight bear as per pre-injury baseline "most of the time"
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2, 4 and 12 weeks post-injury
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Unscheduled visits
Time Frame: 4 weeks post injury
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Proportion of children with unscheduled visits to a physician for the index injury, measured by parental report and Canadian Institute of Health Information data.
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4 weeks post injury
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Day-to-day issues
Time Frame: 4 weeks post injury
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Parental perceptions of challenging issues during the four weeks post-injury will be measured using a five point Likert Scale
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4 weeks post injury
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Immobilization strategy satisfaction
Time Frame: 4 weeks post injury
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Proportion of parents who were at least "satisfied" with the treatment device measured on a five point Likert scale
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4 weeks post injury
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1000063960
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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