Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00132964
Status:
COMPLETED
Last Update Posted:
2021-09-30
First Post:
2005-08-19
Brief Title:
Brace Versus Casting in Pediatric Low Risk Ankle Fractures
Sponsor:
The Hospital for Sick Children
Organization:
The Hospital for Sick Children
Study Overview
Official Title:
Randomized Control Trial of Casting Versus Ankle Bracing in Children With Low-risk Ankle Fractures
Status:
COMPLETED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 005 beta 02 and 10 dropout rate yields a sample size of 112 patients Secondary analyses will include Fishers 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 Students 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
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 005 beta 02 and 10 dropout rate yields a sample size of 112 patients Secondary analyses will include Fishers 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 Students 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None