Brace Versus Casting in Pediatric Low Risk Ankle Fractures

NCT00132964 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 111

Last updated 2021-09-30

Study results available
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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.

Conditions

  • Ankle Fracture

Interventions

DEVICE

Below knee walking cast

Not required

DEVICE

Removable ankle brace

not required

Sponsors & Collaborators

  • The Physicians' Services Incorporated Foundation

    collaborator OTHER
  • The Hospital for Sick Children

    lead OTHER

Principal Investigators

  • Kathy K Boutis, MD · The Hospital for Sick Children

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-07-31
Primary Completion
2005-11-30
Completion
2005-11-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00132964 on ClinicalTrials.gov