Boutis Kathy, Willan Andrew R, Babyn Paul, Narayanan Unni G, Alman Benjamin, Schuh Suzanne
Division of Emergency Medicine, Hospital for Sick Children, 555 University Ave, Toronto, Ontario, Canada M5G 1X8.
Pediatrics. 2007 Jun;119(6):e1256-63. doi: 10.1542/peds.2006-2958.
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.
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.
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.
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.
儿童孤立性腓骨远端踝关节骨折非常常见,未来发生并发症的风险极低。然而,这些骨折的标准治疗方法仍然是石膏固定,这种做法存在风险、不便之处,且需要使用专科医疗资源。因此,本研究的主要目的是确定使用可拆除踝关节支具治疗这些低风险踝关节骨折的儿童,其身体功能恢复是否至少与使用石膏固定治疗的儿童一样有效。
这是一项非劣效性、随机、单盲试验,将5至18岁在儿科急诊科接受低风险踝关节骨折治疗的儿童随机分配至可拆除踝关节支具组或膝下行走石膏组。4周时的主要结局是身体功能,采用改良的儿童活动量表进行测量。其他结局包括患者偏好和成本。
支具组(n = 54)4周时的平均活动评分为91.3%,显著高于石膏组(n = 50)的平均85.3%。与石膏固定治疗的儿童相比,使用支具治疗的儿童在4周时显著更多地恢复到基线活动水平(80.8%对59.5%)。54%接受石膏固定的儿童更喜欢支具,但接受支具治疗的儿童中只有5.7%更喜欢石膏。成本效益可接受性曲线始终>80%;因此,与石膏相比,支具具有成本效益。
在身体功能恢复方面,可拆除踝关节支具比石膏更有效,与更快恢复到基线活动相关,在患者偏好方面更具优势,并且具有成本效益。