Brace Versus Casting in Pediatric Low Risk Ankle Fractures

NCT00132964 | Completed Results

• 1 other identifier: 1000000188
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

pediatric; ankle fractures; randomized controlled trial; management

Outcome Measures

Primary Outcomes (1)

• 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.

  4 weeks

Secondary Outcomes (3)

• Pain at 4 Weeks

  4 weeks

• Range of Motion at 4 Weeks

  4 weeks

• Health Economic Outcomes

  12 weeks

Study Arms (2)

Immobilizaton device

ACTIVE COMPARATOR

Below Knee walking cast

Device: Below knee walking cast

Immobilization device

EXPERIMENTAL

Removable ankle brace

Device: Removable ankle brace

Interventions

Below knee walking cast DEVICE

Not required

Immobilizaton device

Removable ankle brace DEVICE

not required

Immobilization device

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• The Physicians' Services Incorporated Foundation: collaborator

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (1)

• Boutis K, Willan AR, Babyn P, Narayanan UG, Alman B, Schuh S. A randomized, controlled trial of a removable brace versus casting in children with low-risk ankle fractures. Pediatrics. 2007 Jun;119(6):e1256-63. doi: 10.1542/peds.2006-2958.

  PMID: 17545357 RESULT

MeSH Terms

Conditions

Ankle Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Ankle Injuries; Leg Injuries

Results Point of Contact

• Title: Kathy Boutis
• Organization: Hospital for Sick Children

kathy.boutis@sickkids.ca

4168138982

Study Officials

• Kathy K Boutis, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: August 19, 2005
• First Posted: August 22, 2005
• Study Start: July 1, 2003
• Primary Completion: November 1, 2005
• Study Completion: November 1, 2005
• Last Updated: September 30, 2021
• Results First Posted: September 12, 2019

Record last verified: 2021-09

Locations

CA (1)