Toddler's FractureNCT03971448
Toddlers Fractures - Cast Versus Removable Boot
A study testing LPWB and AKWC in people with Toddler's Fracture, run by The Hospital for Sick Children at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 months to 4 years
- Conditions the study is for
- Toddler's Fracture
- What is being tested?
- LPWB and AKWC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2020to 15 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 months to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Control Trial of Casting Versus Pediatric Walker-Boot in the Management of Toddler's Fractures
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.
Read the 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.
- Conditions
- Toddler's Fracture
- Being tested
- LPWB, AKWC
- Keywords
- Cast, Removable device/boot, Immobilization strategy, Emergency Department
- Medical subject headings
- Tibial Fractures, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LPWBDevice
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.
AKWCDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: LPWB |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks post injury
Secondary outcomes (5)
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.
Measured: 4 and 12 weeks post injury
Weight-bearing as per baseline
Proportion of children that weight bear as per pre-injury baseline "most of the time"
Measured: 2, 4 and 12 weeks post-injury
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.
Measured: 4 weeks post injury
Day-to-day issues
Parental perceptions of challenging issues during the four weeks post-injury will be measured using a five point Likert Scale
Measured: 4 weeks post injury
Immobilization strategy satisfaction
Proportion of parents who were at least "satisfied" with the treatment device measured on a five point Likert scale
Measured: 4 weeks post injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study start1 Jan 2020
- Primary completion15 Mar 2024
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Toddler's FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Population Services International
- Responsible party
- Principal investigator, Kathy Boutis, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03971448
- Sponsor's protocol ID
- 1000063960
- Status last verified
- May 2025
- First submitted
- 30 May 2019
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Plan for future analyses and would need a data sharing agreement.
Publications
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.
PubMed 40257790
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial of Casting Versus Pediatric Walker-Boot in the Management of Toddler's Fractures
- ClinicalTrials.gov ID
- NCT03971448
- Acronym / sponsor ID
- 1000063960
- Conditions
- Toddler's Fracture
- Keywords
- Cast, Removable device/boot, Immobilization strategy, Emergency Department
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Population Services International
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 3 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Enrolled children will be randomly assigned to either a fiberglass above-knee walking cast (AKWC) or the Landmark Pediatric Walker Boot (LPWB).
| Arm | Type | Receives |
|---|---|---|
| Fiberglass above-knee walking cast (AKWC) | Active comparator | Device: AKWCThe 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. |
| Landmark Pediatric Walker Boot (LPWB) | Experimental | Device: LPWBThe 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. |
Who may qualify
- Ages
- 9 months to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LPWBThe 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. | Device | Landmark Pediatric Walker Boot (LPWB) |
| AKWCIf 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. | Device | Fiberglass above-knee walking cast (AKWC) |
Primary outcome
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.
5 secondary outcomes
Complications
Time frame: 4 and 12 weeks post injury
Weight-bearing as per baseline
Time frame: 2, 4 and 12 weeks post-injury
Unscheduled visits
Time frame: 4 weeks post injury
Day-to-day issues
Time frame: 4 weeks post injury
Immobilization strategy satisfaction
Time frame: 4 weeks post injury
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Derived from this study: PubMed 40257790Boutin 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.
- Individual participant dataSharing planned: No. Plan for future analyses and would need a data sharing agreement.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LPWB and AKWC in people with Toddler's Fracture, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EValuation ENfant DOuLeur (EVENDOL) pain score at four weeks (time frame: 4 weeks post injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03971448, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.