N/A
N=111
Brace Versus Casting in Pediatric Low Risk Ankle Fractures
Ankle Fracture
Bottom Line
View on ClinicalTrials.gov: NCT00132964 ↗Enrolled (actual)
111
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: Functional Outcome as Measured by the Activities Scale for Kids at 4 Weeks From the Time of the Initial Injury — 85.3; 91.3 percentage of questions
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Below knee walking cast (Device); Removable ankle brace (Device)
- Age
- Pediatric, Adult · 5+ yrs
- Sex
- All
- Sponsor
- The Hospital for Sick Children
- Primary completion
- Nov 2005
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Functional Outcome as Measured by the Activities Scale for Kids at 4 Weeks From the Time of the Initial Injury |
85.3; 91.3 | — |
| SECONDARY Pain at 4 Weeks |
— | — |
| SECONDARY Range of Motion at 4 Weeks |
— | — |
| SECONDARY Health Economic Outcomes |
— | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 5 to 18 years of age with one of the following fractures:
- Undisplaced Salter-Harris types I and II fractures of the distal fibula;
- Avulsion fractures of the distal fibula or distal fibular epiphysis;
- Metaphyseal buckle fractures of the distal fibula;
- Lateral talus fractures.
Exclusion Criteria
- The diagnosis of ankle sprain or contusion; they occur primarily in adolescents with closed epiphyseal plates.
- All open fractures which require surgical debridement.
- All children at risk for pathological fractures such as those with congenital or acquired generalized bony disease.
- Congenital anomalies of the feet and/or ankles.
- Patients with coagulopathies.
- Multisystem trauma and multiple fractures of the same or opposite limb.
- Patients cognitively and developmentally delayed with inability to express pain and/or difficult assessment of baseline activity level.
- Injuries greater than 72 hours old.
- Past history of surgery or closed reduction of the same ankle within the last 6 months or ankle trauma of the same ankle within 3 months.
- Patients who do not have phone or electronic mail access.
- Patients living outside the Greater Toronto area (GTA) and who are unwilling to meet the physiotherapist at Hospital for Sick Children (HSC) for the four week assessment.
Data sourced from ClinicalTrials.gov (NCT00132964). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.