Brace Versus Casting in Pediatric Low Risk Ankle Fractures

This study has been completed.
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by (Responsible Party):
Kathy Boutis, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00132964
First received: August 19, 2005
Last updated: June 5, 2012
Last verified: January 2007
  Purpose

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.


Condition Intervention Phase
Ankle Fracture
Device: Below knee walking cast
Device: Removable ankle brace
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Control Trial of Casting Versus Ankle Bracing in Children With Low-risk Ankle Fractures

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • Functional outcome as measured by the Activities Scale for Kids at 4 weeks from the time of the initial injury [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain at 4 weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Range of motion at 4 weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Health economic outcomes [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 112
Study Start Date: July 2003
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Immobilizaton device
Below Knee walking cast
Device: Below knee walking cast
Not required
Experimental: Immobilization device
Removable ankle brace
Device: Removable ankle brace
not required

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   5 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00132964

Locations
Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
The Physicians' Services Incorporated Foundation
Investigators
Principal Investigator: Kathy K Boutis, MD The Hospital for Sick Children
  More Information

No publications provided

Responsible Party: Kathy Boutis, Physician, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00132964     History of Changes
Other Study ID Numbers: 1000000188
Study First Received: August 19, 2005
Last Updated: June 5, 2012
Health Authority: Canada: Health Canada

Keywords provided by The Hospital for Sick Children:
pediatric
ankle fractures
randomized controlled trial
management

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on July 29, 2014