Randomized Control Trial: Elbow Extension Versus Flexion Cast in Proximal Half Both Bone Forearm Fractures
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Alignment/Loss of Reduction
研究概览
简要总结
The purpose of this study is to compare outcomes between two immobilization methods for pediatric proximal half both bone forearm fractures.
详细描述
After being informed of the study including potential risks and benefits, all patients giving assent and guardian/parents consent who meet eligibility will undergo randomization of the casting technique used (elbow extension or elbow flexion casting). Randomization will occur using a random umber generator. Even numbers generated will result in an extension cast and odd numbers generated will result in a flexion cast.
The patients will be followed in clinic with an examination and x-rays at 2, 3, 5, and 8 weeks after casting to evaluate alignment of the fracture maintained by each cast. The two cohorts will be compared at the end of the study to determine which casting technique is the superior immobilization for pediatric proximal half both bone forearm fractures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Casting is an external treatment that cannot be masked from investigators or participants.
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 3-18
- •Skeletally immature
- •Unilateral Radius and Ulna Fracture located within the proximal ½ of each bone
- •Fracture requires reduction and casting
排除标准
- •Ages < 3
- •Distal ½ Radius and Ulna Forearm Fracture
- •Isolated radius or ulna fracture
- •Humerus Fracture of the Ipsilateral Arm (including floating elbow)
- •Metabolic Bone Disease
- •Open Fractures
- •Monteggia and Galeazzi Fractures
- •Deformity or abnormality not allowing for standard casting (limb deficiency, contracture)
- •Parent speaks language other than english
研究组 & 干预措施
Elbow Flexion Cast
This cohort will be placed in a long arm flexion cast.
干预措施: Cast (Other)
Elbow Extension Cast
This cohort will be placed in a long arm extension cast.
干预措施: Cast (Other)
结局指标
主要结局
Alignment/Loss of Reduction
时间窗: This will be accessed in clinic via x-rays until 8 weeks status post cast application.
During clinic visits, xrays will be obtained to measure alignment of the radius and ulna fracture and asses for loss of reduction or malalignment. We will compare the number of patients with proximal both bone forearm fractures that have lost alignment after 8 weeks between the flexion elbow cast cohort compared to the extension elbow cast cohort.
次要结局
- Cast Complications(Casting complications will be followed the full duration of the patient wearing a cast, which is expected to be around 6-8 weeks.)
研究者
Philip Ashley
Assistant Professor
University of Alabama at Birmingham