CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 111 enrolled
Drug / intervention
Below knee walking cast +1 moredevice
Likely dose
Not stated in record
Key inclusion· 5
  • Age 5 to 18 years
  • 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
Key exclusion· 11
  • Open fractures requiring surgical debridement
  • Risk for pathological fractures (congenital or acquired generalized bony disease)
  • Congenital anomalies of the feet and/or ankles
  • Coagulopathies

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00132964
NCT00132964N/ACompleted

Randomized Control Trial of Casting Versus Ankle Bracing in Children With Low-risk Ankle Fractures

The Hospital for Sick Children·interventional·Posted Aug 22, 2005·Updated Sep 30, 2021

In Brief

A clinical study evaluating Below knee walking cast and Removable ankle brace for Ankle Fracture. Completed, enrolled 111 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnkle Fracture
CountriesCanada

Timeline

N/ACompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 22, 2005
Enrollment StartJul 1, 2003
Primary CompletionNov 1, 2005
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 20.9 years ago

Interventions

Below knee walking castdevice

Not required

Removable ankle bracedevice

not required