An interventional study of Below knee walking cast and Removable ankle brace in Ankle Fracture, sponsored by The Hospital for Sick Children. Completed at 1 site in Canada. Open to participants aged 5 Years to 18 Years. Per ClinicalTrials.gov, last updated 2021-09-30.
Sponsored by The Hospital for Sick Children · Not applicable, Interventional, and Treatment
Acute ankle fractures are common in children. Most of these are stable and have a low risk of problems in the future. Even though these fractures are benign, these injuries are often casted for a fixed time period, which is inconvenient, expensive, and does not appear to be a practice that has been proven to be scientifically correct.
Therefore, in this study, in healthy children with low-risk ankle fractures, we, the investigators at the Hospital for Sick Children, will examine if a removable ankle brace is at least as good as casting with respect to how well and how fast children return to their usual activities. In addition, we will compare the costs of each method for the patient and the health care system.
Successful management of low-risk fractures with an ankle brace will allow for several advantages over the use of the cast. These advantages include the possibility of returning to normal activities faster, fewer visits to specialty hospital clinics, and significant cost savings.
Objective: To determine if a removable ankle brace is at least as effective as casting in children between 5 and 18 years old with low-risk ankle fractures.
Rationale: Ankle injuries are very common among children. The Canadian Health Injury Reporting and Prevention Program reports approximately 5500 ankle injuries per year in children presenting to the 16 participating emergency departments, 35% of which are fractures. The majority of ankle injuries in children, including ankle fractures, have an excellent prognosis with a very low risk for any complications. We have recently shown that a predefined structured 'low-risk' clinical exam reliably identifies these low risk injuries, while simultaneously excluding 100% of high-risk fractures. This clinical rule reduces the need for radiography in children with ankle injuries by 63%. However, all low-risk injuries are currently not managed uniformly. Low-risk ankle fractures are often treated with a cast while soft tissue injuries are treated in a brace. Due to this distinction in management, many physicians still feel compelled to do radiographs in children with low risk ankle injuries in order to identify the fractures. We will now expand our previous work to show that all low risk ankle fractures can be safely treated in the same way as soft tissue injuries of the ankle. The current treatment of low risk fractures is casting which is inconvenient, necessitates orthopedic referral, and may be associated with soft tissue complications. Furthermore, casting is not an evidence-based practice. Preliminary evidence in adults with stable ankle fractures suggests that an ankle brace may offer a safe alternative to casting, while allowing comparable resumption of usual activities and less reliance on sub-specialty care. Therefore, the primary purpose of this study is to compare the functional outcomes that result from ankle bracing with those from casting in children with low-risk ankle fractures.
Design: In this randomized, outcomes assessor blinded, single center trial, children diagnosed with low-risk ankle fractures will receive either an ankle brace or a below-knee walking cast.
Outcome Measures: The primary outcome measure will be an assessment of functional daily activities as measured by the modified performance Activities Scale for Kids (ASKp) at four weeks post injury. Secondary outcomes will include an assessment of pain scores, ankle range of motion and return to baseline function. A concurrent health economic evaluation will be conducted using both patient and health care sector costs.
Sample Size and Analysis: The null hypothesis for the primary analysis is that the brace is less effective than casting by at least five percentage points on the ASKp scale. Assuming a standard deviation of 10%, alpha = 0.05, beta = 0.2 and 10% dropout rate yields a sample size of 112 patients. Secondary analyses will include Fisher's Exact test to compare proportions of children with full range of motion of the injured ankle at four weeks and with full baseline activity level at four months, and the area under the curve of a pain-time profile curve will be compared using a Student's t-test. An economic analysis will assess the incremental net benefit of bracing versus casting from a health care perspective.
Significance: If the removable brace is found to be at least as effective as the cast, this study has the potential to standardize the treatment of all low risk ankle injuries. Since these injuries can be reliably detected by physical examination, routine radiography of these injuries can be eliminated. These injuries could therefore be safely treated by primary physicians, thereby reducing the number of emergency department visits, obviating the need for orthopedic referral, or a return visit for cast removal. As a result, this study will provide critical information about the optimal treatment for the majority of ankle injuries in children from the perspective of clinical efficacy and health economics.
2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.
This study's enrollment of 111 is above the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →The Hospital for Sick Children is the lead sponsor of 568 studies on the registry; 81 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
5 to 18 years of age with one of the following fractures:
Exclusion Criteria:
Below Knee walking cast
Device: Below knee walking cast
Removable ankle brace
Device: Removable ankle brace
Not required
not required
Functional Outcome as Measured by the Activities Scale for Kids at 4 Weeks From the Time of the Initial Injury
Activities Scale for Kids (ASKp) measured by a physiotherapist at 4 week visit and is a validated 38-questionnaire that targets activities of children. The minimal scores are 0 and maximum are 100. Higher score indicates higher function.
Time frame: 4 weeks
Pain at 4 Weeks
Bieri Face Pain Scale (BFPS). This is scored as 0, 2, 4, 6, 8, 10. The minimum and maximum values are 0 and 10 respectively. A higher score reports worse pain.
Time frame: 4 weeks
Range of Motion at 4 Weeks
Goniometer measured by a physiotherapist
Time frame: 4 weeks
Health Economic Outcomes
parent reported costs and health care system costs
Time frame: 12 weeks
| Milestone | Immobilizaton Device | Immobilization Device |
|---|---|---|
| Started | 54 | 57 |
| Completed | 50 | 54 |
| Not completed | 4 | 3 |
Activities Scale for Kids (ASKp) measured by a physiotherapist at 4 week visit and is a validated 38-questionnaire that targets activities of children. The minimal scores are 0 and maximum are 100. Higher score indicates higher function.
| percentage of questions | Immobilizaton Device | Immobilization Device |
|---|---|---|
| Functional Outcome as Measured by the Activities Scale for Kids at 4 Weeks From the Time of the Initial Injury | 85.3 ± 2.06 | 91.3 ± 1.14 |
Bieri Face Pain Scale (BFPS). This is scored as 0, 2, 4, 6, 8, 10. The minimum and maximum values are 0 and 10 respectively. A higher score reports worse pain.
Results for this outcome have not been posted.
Goniometer measured by a physiotherapist
Results for this outcome have not been posted.
parent reported costs and health care system costs
Results for this outcome have not been posted.
Collected over 2 years. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Immobilizaton Device | 0/54 (0%) | 0/54 (0%) | 4/54 (7.4%) |
| Immobilization Device | 0/57 (0%) | 0/57 (0%) | 16/57 (28.1%) |
| Event | Immobilizaton Device | Immobilization Device |
|---|---|---|
| Poor Fit of Immobilization DeviceSkin and subcutaneous tissue disorders | 4/54 | 16/57 |
| Age, Categorical(Participants) | Immobilizaton Device | Immobilization Device | Total |
|---|---|---|---|
| <=18 years | 54 | 57 | 111 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Immobilizaton Device | Immobilization Device | Total |
|---|---|---|---|
| Mean | 10.55 ± 2.91 | 9.94 ± 2.43 | 10.2 ± 2.62 |
| Sex: Female, Male(Participants) | Immobilizaton Device | Immobilization Device | Total |
|---|---|---|---|
| Female | 25 | 25 | 50 |
| Male | 29 | 32 | 61 |
| Region of Enrollment(participants) | Immobilizaton Device | Immobilization Device | Total |
|---|---|---|---|
| Canada | 54 | 57 | 111 |
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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