Published online June 1, 2007
PEDIATRICS Vol. 119 No. 6 June 2007, pp. e1256-e1263 (doi:10.1542/peds.2006-2958)
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ARTICLE

A Randomized, Controlled Trial of a Removable Brace Versus Casting in Children With Low-Risk Ankle Fractures

Kathy Boutis, MDa,b, Andrew R. Willan, PhDb, Paul Babyn, MDc, Unni G. Narayanan, MDb,d, Benjamin Alman, MDd and Suzanne Schuh, MDa,b

a Division of Emergency Medicine
b Population Health Sciences, Research Institute
c Divisions of Diagnostic Imaging
d Orthopedic Surgery, Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada


   ABSTRACT
TOP
 ABSTRACT
METHODS
 RESULTS
 DISCUSSION
 CONCLUSIONS
 REFERENCES
 
OBJECTIVES. Isolated distal fibular ankle fractures in children are very common and at very low risk for future complications. Nevertheless, standard therapy for these fractures still consists of casting, a practice that carries risks, inconveniences, and use of subspecialty health care resources. Therefore, the main objective of this study was to determine whether children who have these low-risk ankle fractures that are treated with a removable ankle brace have at least as effective a recovery of physical function as those that are treated with a cast.

METHODS. This was a noninferiority, randomized, single-blind trial in which children who were 5 to 18 years of age and treated in a pediatric emergency department for low-risk ankle fractures were randomly assigned to a removable ankle brace or a below-knee walking cast. The primary outcome at 4 weeks was physical function, measured by using the modified Activities Scale for Kids. Additional outcomes included patient preferences and costs.

RESULTS. The mean activity score at 4 weeks was 91.3% in the brace group (n = 54), and this was significantly higher than the mean of 85.3% in the cast group (n = 50). Significantly more children who were treated with a brace had returned to baseline activities by 4 weeks compared with those who were casted (80.8% vs 59.5%). Fifty-four percent of the casted children would have preferred the brace, but only 5.7% of children who received the brace would have preferred the cast. The cost-effectiveness acceptability curve was always >80%; therefore, the brace was cost-effective compared with the cast.

CONCLUSIONS. The removable ankle brace is more effective than the cast with respect to recovery of physical function, is associated with a faster return to baseline activities, is superior with respect to patient preferences, and is also cost-effective.

Key Words: children • fractures • treatment • ankle

Abbreviations: ED—emergency department • PEM—pediatric emergency medicine • ASKp—performance version of Activities Scale for Kids • H0—null hypothesis

Ankle injuries are very common among children.1 However, most ankle injuries are minor with little need for imaging or for subspecialty care.2,3 They include sprains and fractures such as isolated distal fibular fractures, which are the most common fractures of the lower extremity.3–5 These fractures are stable and at negligible risk for premature closure of the growth plate because fractures through fibular growth plate typically spare the zone of proliferation where the growth occurs.3,6,7 Despite their benign natural history,3,4,6–9 these stable, low-risk fractures are often immobilized in a cast for 3 to 4 weeks.1,4 The main disadvantages of casting include unpleasant and prolonged immobilization and the inconvenience of return visits to an orthopedic facility. Moreover, casting may be unnecessary and expensive and may have complications that potentially are greater than those that are associated with the fracture itself.10 Therefore, a comparison of this traditional treatment with a more convenient method is imperative. The single study that found that children who had Salter-Harris I fractures of the distal fibula and were treated with a tensor bandage returned to normal activities sooner than did those who were treated in a cast11 was limited by the use of unvalidated outcome measures that were assessed by investigators who were not blinded to the treatment allocation. Therefore, solid evidence to support the use of a more cost-effective alternative form of immobilization that offers comparable comfort and return to activities is lacking.

Our study challenged the current practice of routine casting and the necessity for orthopedic care. This is the first randomized, controlled trial to compare a removable ankle brace with conventional rigid cast immobilization for low-risk ankle fractures in children in terms of recovery of physical function. In addition, because the brace may result in lower morbidity and reduced use of health care resources compared with casting, a formal cost-effectiveness analysis was a part of this trial.


   METHODS
TOP
 ABSTRACT
 METHODS
RESULTS
 DISCUSSION
 CONCLUSIONS
 REFERENCES
 
Study Patients
Enrollment occurred from July 2003 to September 2005 at an urban, tertiary care pediatric emergency department (ED). Children were eligible when they were between 5 and 18 years of age and presented to the ED at the Hospital for Sick Children with an acute, symptomatic, low-risk ankle fracture within 72 hours after injury. Isolated low-risk fractures of the ankle included undisplaced distal fibular types I and II Salter-Harris fractures and avulsion fractures of the distal fibula or fibular epiphysis (Fig 1). Because undisplaced Salter-Harris type I fractures are not evident on radiographs and the accepted standard for diagnosis of this fracture is based on clinical findings, a presumptive diagnosis of this fracture was made using the following predefined criteria: age ≤12 years, inability to bear weight,3,12 an examination consistent with maximal tenderness and swelling over the distal fibular growth plate,4,5 and a radiograph demonstrating the absence of bony fracture with evidence of soft tissue swelling over the open distal fibular growth plate. The physis is the weakest part of the pediatric musculoskeletal system; consequently, sprains occur infrequently in children with the aforementioned criteria.1,4,5 Excluded were children with preexisting musculoskeletal disease, coagulopathies, or developmental delay; patients with a history of surgery or injury of the affected ankle within 3 months of the index visit; children with multisystem or multilimb trauma; children with distal tibial, foot, and/or open fractures; those who lived outside the greater Toronto area; and those who did not have e-mail or telephone access. The study was approved by the institutional human ethics review board. A record of patients who were missed and whose parents declined participation was kept to assess the generalizability of the study.


Figure 1
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  		FIGURE 1 Radiographs of distal fibular fracture types included in the study.

 
Recruitment and Baseline Assessment
Before the study, pediatric emergency medicine (PEM) staff physicians and research assistants were instructed by the participating orthopedic surgeons in the physical examination of the ankle and the accurate diagnosis of the eligible ankle injuries. The triage nurse alerted the research team about all ankle injuries that presented to the ED between the hours of 8:00 and 12:00AM. These children were assessed by both the research nurse and staff PEM physicians. The patients were sent for the standard ankle (anteroposterior, lateral, and mortise) radiographs. The on-call radiologist analyzed the radiographs to record whether the growth plate was open or closed and for the presence of soft tissue swelling, effusions, and fractures. The final diagnosis was made by the PEM staff physician on the basis of clinical examination and the radiologist's report. When a child met eligibility criteria, informed consent and assent (children ≥7 years) was obtained. A standardized study sheet that contained the clinical data and a detailed diagram of the ankle (prepared a priori by the investigative team) was completed for each child. The time and mechanism of injury, ability to bear weight, sociodemographic factors, and physical examination findings were recorded. Physical examination findings included the site of maximal pain and tenderness, the presence and the location of swelling, and degree of pain with weight bearing. Patients also completed the modified performance Activities Scale for Kids (ASKp)(refs 13–16; N. L. Young, PhD, written communication, 2002) to assess baseline physical function in the week before the injury.

Randomization
Recruited patients were randomly assigned to receive either an ankle brace or a below-knee fiberglass cast. Concealed treatment allocation was provided by an on-line randomization program (www.randomize.net) using block randomization with random block sizes of 6 and 8, with immediate e-mail notification of treatment group to the research coordinator.

Study Interventions
A trained research cast technician placed either a below-knee fiberglass walking cast or the Aircast (Vista, CA) Air-Stirrup ankle brace in accordance with the patient's group assignment. Patients were instructed to wear a sock and a shoe in conjunction with the brace. All patients were provided with crutches. After a period of no weight bearing for 5 days in their respective immobilization devices, both populations were instructed to bear weight as tolerated and to transition to full, unassisted weight bearing and activities if there was no pain. The patients in the brace group were instructed to remove the Air-Stirrup when comfortable with ambulating after the initial 5-day period. Apart from specific instructions regarding care of the cast or the ankle brace, both populations received identical instructions on initial elevation and non–weight-bearing guidelines, type and frequency of analgesics, and reasons to return for medical attention before scheduled follow-up appointments. Study patients were not scheduled for any follow-up radiographs.

Patients received weekly follow-up telephone calls over 4 weeks to address parental concerns and remind families to complete the expense and clinical diaries provided in the ED. The clinical diary was used to record the actual amount and frequency of analgesia, weekly pain scores, and weekly return to baseline activities. The expense diary included any costs incurred by the family during a 4-week period related to the index ankle injury. Children who were treated with cast immobilization were provided an appointment to return 3 weeks after injury to our orthopedic clinic for removal of the cast.

Within 1 week of patient recruitment, a single staff radiologist who had expertise in pediatric musculoskeletal imaging and was blinded to the details of the initial presentation and initial radiology report read all study radiographs to ensure consistency of interpretation and to ascertain that there were no diagnostic errors at the ED visit. Differences of opinion with respect to the final radiographic diagnosis were resolved by consensus after review of the clinical history and radiographs with the collaborating orthopedic surgeon and the participating radiologist.

Four weeks after the injury, all patients were visited at home by the research physiotherapist, who was blinded to the treatment allocation. To preserve blinding, patients and families were instructed not to mention to the visiting physiotherapist which immobilization device the patient received. All patients were also provided with an opaque stocking that was placed on the affected leg before the physiotherapist's assessment. The physiotherapist ensured completion of the 4-week assessments and collected the completed diaries. Three months after injury, the patients were telephoned by a blinded research assistant to assess subsequent complications.

Outcome Measures
The primary outcome measure was the modified ASKp score (refs 13–16; N. L. Young, PhD, written communication, 2002) at 4 weeks. The modified ASKp is an assessment of a child's current physical function that is based on activities performed during the week before completion of the questionnaire. The questionnaire has 30 items that reflect clinician and child perspectives on pediatric daily activities.16 The ASKp has been found to be highly reliable,13,14 have excellent construct validity, and be responsive to change.13,14,16,17 The ASKp has been validated in 5- to 15-year-old children with fractures and other musculoskeletal problems.16 Because only 70% of the questions in the ASKp pertain directly or indirectly to ankle function, 8 additional questions related to ankle activity were included in consultation with the author of the ASKp to create a modified ASKp score. Secondary outcome measures also obtained at the 4-week follow-up visit included range of motion as measured by a certified physiotherapist using a goniometer,18,19 pain with walking using the validated Bieri Face Pain Scale-Revised,20–22 return to baseline activities as reported by parents, and patient preferences for 1 immobilization device versus the other.

Data on health care resources used included over-the-counter medications used, physician visits, ankle radiographs, casting (cast changes/replacements), and use of ankle braces. Total patient health care costs were estimated by multiplying health care resource use data by corresponding unit prices. Price sources included a survey of pharmacies, Ontario Schedule of Physician Benefits for physician fees and procedures, and manufacturers for cast materials and ankle brace. Additional costs included travel, child care expenses, and parental lost productivity. Cost for lost productivity was determined by multiplying $20.80, the average hourly wage of all employees between the ages of 24 and 54 from the 2005 Canadian Labor Force survey, by the number of hours reported off work. All costs and unit prices are given in Canadian dollars.

Statistical Analysis
All analyses were by intention to treat. The sample size was determined using methods that are appropriate for noninferiority trials (ie, trials with nonzero null hypotheses).23–26 The sample size of 111 patients was based on testing the null hypothesis (H0) that the brace is ≥5% less effective than a cast on the basis of the ASKp scores at 4 weeks, at the 5% level, and having an 80% probability of rejecting H0 if brace and cast are equally effective. A 5% difference in effectiveness was chosen because it is approximately the difference in average ASKp scores between normal and mildly disabled patients (N. L. Young, PhD, written communication, 2002). In addition, it was assumed that ~10% of patients would be lost to follow-up. H0, based on the week 4 ASKp scores, was tested by a t test for a nonzero difference. For the other clinical outcomes, traditional 0 H0s were tested. Proportions were compared with Fisher's exact tests, means were compared with Student's t tests, and Cochrane test for trend was used to compare treatment arms with respect to the ordered categorical outcome of patient satisfaction.

For the cost-effectiveness analysis, mean costs by treatment arm and between–treatment arm differences in mean costs were estimated assuming a {gamma} distribution to accommodate right skewing. Estimation was performed using Markov-chain Monte Carlo methods as facilitated by the software WinBUGS with vague priors (WinBUGS 1.4; MRC Biostatistics Unit, Cambridge, United Kingdom). To conduct a cost-effectiveness analysis, we performed the simultaneous estimation of the between–treatment arm differences in mean costs and effectiveness (week 4 ASKp scores), along with the corresponding variances and covariances, using Markov-chain Monte Carlo methods as facilitated by the WinBUGS software with vague priors.27


   RESULTS
TOP
 ABSTRACT
 METHODS
 RESULTS
DISCUSSION
 CONCLUSIONS
 REFERENCES
 
Patient Recruitment and Baseline Characteristics
During the study period, 679 ankle injuries presented to the ED, 607 of which were screened. Of the 72 missed patients, 5 presented outside study recruitment times, and in the remaining cases, the ED staff did not alert study personnel. Of these, 12 would have been eligible for recruitment and 60 met exclusion criteria. Of the 607 screened patients, 475 were ineligible. Twenty-one of the 132 eligible patients declined participation. Of the 111 children who were enrolled and randomly assigned, 104 were included in the final analysis (Fig 2). Baseline characteristics of the study groups are summarized in Table 1.


Figure 2
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  		FIGURE 2 Flow of study patients.

 

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  		TABLE 1 Baseline Variables

 
Follow-up
Follow-up of the primary outcome, ASKp at 4 weeks, was completed in 103 of (99.0%) 104 of the children who were included in the final analysis. Ninety-nine (95.2%) of the patients completed the clinical diary, and 98 (94.2%) completed the expense diary. Ninety-four (90.4%) of the patients were reached for the 3-month follow-up telephone call.

Functional Outcomes
The mean ASKp (±SE) at 4 weeks was 91.3% (±1.14%) in the brace group compared with 85.3% (±2.06%) in the cast group. The difference between the mean ASKp(brace) and the mean ASKp(cast) was therefore 6% in favor of the brace, and the lower bound of the 95% confidence interval for this difference was 1.13%. As a result, the H0 that the mean ASKp(brace) is inferior by 5% or more can be rejected (P < .0001). Furthermore, because the lower bound of the 95% confidence interval is positive, the hypothesis that the brace is inferior by any amount can also be rejected at the 5% level.28,29

Although there were no differences in the 2 groups in pain, ability to bear weight, and range of motion at 4 weeks, a significantly greater proportion of children in the brace group compared with their casted counterparts had returned to baseline activities by this time (Table 2). At 3 months, there were no differences in pain, other residual symptoms such as swelling, and activity levels.


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  		TABLE 2 Comparison of Secondary Outcomes at 4 Weeks

 
Immobilization Devices
Four of the 50 children in the cast group had their casts removed prematurely at 2 weeks. Two were placed in a brace, and 2 had no additional immobilization. These children were treated in the orthopedic fracture clinic by residents who were unfamiliar with the study and who therefore chose management independent of study protocol. Figure 3 demonstrates brace usage during the 4-week period. There were no crossovers from the brace to the cast group.


Figure 3
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  		FIGURE 3 Brace use.

 
Complications and Co-interventions
Twenty patients had unscheduled visits to a health care provider: 16 (32.0%) in the cast group and 4 (7.4%) in the brace group. Patients visited at least 1 of the following: primary care provider (5 casts, 2 braces), cast clinic (4 casts, no braces), ED (3 casts, 1 brace), physiotherapist (3 casts, no braces), and/or a sports medicine clinic (1 cast, 1 brace). Reasons in the cast group included poor cast fit, itchy leg, and strength and range-of-motion issues. In the brace group, 1 patient developed a rash on the leg (likely as a result of not wearing socks with the brace), and the remaining 3 children had strength and range-of-motion issues. There were no serious adverse events in either group.

Patient and Parent Satisfaction and Preference
Patients and parents were asked at the 4-week visit how satisfied they were with the immobilization device and whether at any point they would have preferred an alternative device. Twenty-eight (52.8%) patients in the brace group rated themselves as "very happy" compared with 9 (18%) "very happy" patients in the cast group. Only 3 (5.7%) in the brace group reported that they would have preferred a cast, whereas 27 (54%) in the cast group reported that they would have preferred a brace. It is interesting that although there were no differences in parental preference, parental satisfaction with the brace, as measured by report of satisfaction on a 4-point Likert scale, was significantly greater than that reported in the cast group (P < .0001; Table 2).

Cost-effectiveness
The between-treatment cost comparisons are reported in Table 3. Total costs do not equal the sum of the 3 components because of the nonlinearity of the estimation procedure based on the {gamma} distribution. Total costs and health care costs were observed to be lower in the brace arm, whereas parental work loss costs and other costs were higher in the brace arm. Health care cost differences between the 2 interventions achieved statistical significance (P < .0001), favoring the brace. The cost-effectiveness acceptability curve is a plot of the probability that the brace is cost-effective as a function of the willingness to pay for a unit of effectiveness.30,31 Because the brace is observed to be more effective and less costly and the cost-effectiveness acceptability curve was always >80%, the brace is observed to be cost-effective compared with cast.


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  		TABLE 3 Estimated Means and SEs for Costs According to Treatment Arm

 

   DISCUSSION
TOP
 ABSTRACT
 METHODS
 RESULTS
 DISCUSSION
CONCLUSIONS
 REFERENCES
 
This study is the first to demonstrate that a removable ankle brace is more effective than the below-knee walking cast with respect to recovery of physical function in children with low-risk ankle fractures. In addition, the brace was observed to be cost-effective and superior with respect to return to baseline activities and patient preferences. The brace can initially be applied readily by any health care provider and applied or taken off easily by older children or an adult family member and therefore does not require specialty orthopedic involvement, which is usually necessary for a cast. The convenience and efficiency of the brace may reduce costs, avoid ED visits for patients who receive a diagnosis of these injuries in a primary care setting, reduce time spent in the ED, and obviate the need for follow-up visits in busy32 general or pediatric orthopedic clinics.

The previously determined difference of the mean ASKp for "normal" versus "mild" disability is ~5% (N. L. Young, PhD, written communication, 2002). Therefore, the mean score difference of 6% in favor of the brace is clinically significant. In addition, the absolute mean score in the brace group was close to "normal" level, whereas that of the casted counterparts more closely correlated with "mild" disability (ref 33; N. L. Young, PhD, written communication, 2002). Therefore, our results achieved both statistical and clinical significance.

Our results are consistent with the findings by Gleeson et al,11 which showed that children who had Salter-Harris I fractures of the distal fibula and were treated with a tensor bandage returned to baseline activities ~7 days sooner than those in the below-knee walking cast. Our study used a reliable and well-validated primary outcome measure16 that was measured by an outcomes assessor who was blinded to the treatment group. Furthermore, in addition to the Salter-Harris I fracture of the distal fibula, our study included Salter-Harris II and avulsion fibular fractures.

The absence of any serious adverse events in either group is consistent with the knowledge about isolated distal fibular fractures.3,6,34 The long-term complication of growth arrest in these fractures is very rare,3,6,7 and even if it occurs, there is no evidence to support that casting prevents this outcome or that it results in any functional impairment of the ankle.3 The complications that did occur were minor and could easily be assessed by a primary care provider with subsequent referrals to a physiotherapist or sports medicine clinic as required. Therefore, if the brace is used, then the routine referral of these low-risk ankle fractures to an orthopedic surgeon becomes unnecessary.

This study has 2 main limitations. First, our results may not be generalizable to physicians with limited expertise in diagnosing low-risk ankle fractures in children. Second, it is uncertain whether the high use of the brace in the early period of treatment reflected the increased vigilance that patients received during the study as opposed to what may happen in reality in the absence of weekly follow-up.


   CONCLUSIONS
TOP
 ABSTRACT
 METHODS
 RESULTS
 DISCUSSION
 CONCLUSIONS
REFERENCES
 
In children with low-risk ankle fractures, the removable brace is more effective than the cast with respect to an earlier recovery of physical function, is associated with greater patient/family satisfaction, and is less costly than the traditional casting.


   ACKNOWLEDGMENTS
 
This study was supported by a grant from Physician Services Inc.

We acknowledge Dr Martin Pecaric of Contrail Consulting Services for data entry and graphic design of figures in the manuscript. Also, we thank Aircast for providing, free of charge, the Air-Stirrup ankle braces that were used in the study.


   FOOTNOTES
 
Accepted Dec 12, 2006.

Address correspondence to Kathy Boutis, MD, Division of Emergency Medicine, Hospital for Sick Children, 555 University Ave, Toronto, Ontario, Canada M5G 1X8. E-mail: boutis{at}pol.net

The authors have indicated they have no financial relationships relevant to this article to disclose.


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PEDIATRICS (ISSN 1098-4275). ©2007 by the American Academy of Pediatrics



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Bracing Is Better Than Casting for Some Ankle Fractures
Journal Watch Pediatrics and Adolescent Medicine, August 1, 2007; 2007(801): 2 - 2.
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