Brace Versus Casting in Pediatric Low Risk Ankle Fractures

• Sponsor: The Hospital for Sick Children (Other)
• Overall Status: Completed
• CT.gov ID: NCT00132964
• Collaborator: The Physicians' Services Incorporated Foundation (Other)
• Enrollment: 111
• Location: 1
• Arms: 2
• Duration (Months): 28.1
• Patients Per Site Per Month: 4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ankle Fracture	Device: Below knee walking cast; Device: Removable ankle brace	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 111 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Randomized Control Trial of Casting Versus Ankle Bracing in Children With Low-risk Ankle Fractures
• Study Start Date: Jul 1, 2003
• Actual Primary Completion Date: Nov 1, 2005
• Actual Study Completion Date: Nov 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Functional Outcome as Measured by the Activities Scale for Kids at 4 Weeks From the Time of the Initial Injury [4 weeks]

   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.

Secondary Outcome Measures

1. Pain at 4 Weeks [4 weeks]

   Bieri Face Pain Scale (BFPS). This is scored as 0, 2, 4, 6, 8, 10. The minimum and maximum values are 0 and 10 respectively. A higher score reports worse pain.

2. Range of Motion at 4 Weeks [4 weeks]

   Goniometer measured by a physiotherapist

3. Health Economic Outcomes [12 weeks]

   parent reported costs and health care system costs

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kathy Boutis, Physician, The Hospital for Sick Children
• ClinicalTrials.gov Identifier: NCT00132964
• Other Study ID Numbers: 1000000188
• First Posted: Aug 22, 2005
• Last Update Posted: Sep 30, 2021
• Last Verified: Sep 1, 2021

• Keywords provided by Kathy Boutis, Physician, The Hospital for Sick Children: pediatric; ankle fractures; randomized controlled trial; management
• Additional relevant MeSH terms: Fractures, Bone; Ankle Fractures

Study Results

Participant Flow

Arm/Group Title	Immobilizaton Device	Immobilization Device
Arm/Group Description	Below Knee walking cast was placed on the ankle injury.	Removable ankle brace was placed on the injured ankle.
Period Title: Overall Study
STARTED	54	57
COMPLETED	50	54
NOT COMPLETED	4	3

Baseline Characteristics

Arm/Group Title	Immobilizaton Device	Immobilization Device	Total
Arm/Group Description	Below Knee walking cast	Removable ankle brace	Total of all reporting groups
Overall Participants	54	57	111
Age (Count of Participants)
<=18 years	54 100%	57 100%	111 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	10.55 (2.91)	9.94 (2.43)	10.2 (2.62)
Sex: Female, Male (Count of Participants)
Female	25 46.3%	25 43.9%	50 45%
Male	29 53.7%	32 56.1%	61 55%
Region of Enrollment (participants) [Number]
Canada	54 100%	57 100%	111 100%

Outcome Measures

1. Primary Outcome

Title	Functional Outcome as Measured by the Activities Scale for Kids at 4 Weeks From the Time of the Initial Injury
Description	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.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Immobilizaton Device	Immobilization Device
Arm/Group Description	Below Knee walking cast	Removable ankle brace that you placed on the injured ankle and can be removed as needed by the patient
Measure Participants	50	54
Mean (Standard Error) [percentage of questions]	85.3 (2.06)	91.3 (1.14)

2. Secondary Outcome

Title	Pain at 4 Weeks
Description	Bieri Face Pain Scale (BFPS). This is scored as 0, 2, 4, 6, 8, 10. The minimum and maximum values are 0 and 10 respectively. A higher score reports worse pain.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Range of Motion at 4 Weeks
Description	Goniometer measured by a physiotherapist
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Health Economic Outcomes
Description	parent reported costs and health care system costs
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	2 years
Arm/Group Title	Immobilizaton Device		Immobilization Device
Arm/Group Description	Below Knee walking cast		Removable ankle brace
All Cause Mortality
	Immobilizaton Device		Immobilization Device
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/54 (0%)		0/57 (0%)
Serious Adverse Events
	Immobilizaton Device		Immobilization Device
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/54 (0%)		0/57 (0%)
Other (Not Including Serious) Adverse Events
	Immobilizaton Device		Immobilization Device
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/54 (7.4%)		16/57 (28.1%)
Skin and subcutaneous tissue disorders
Poor Fit of Immobilization Device	4/54 (7.4%)	4	16/57 (28.1%)	16

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.