Prospective Evaluation of Loss of Reduction and Cast Parameters Following Cast Bivalving for Pediatric Distal Radius Fractures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in reduction after bivalving
研究概览
简要总结
Pediatric patients with distal radius fractures are most commonly treated non-operatively with fracture reduction and cast immobilization. In order to prevent complications from increased swelling after the injury (or fracture manipulation) casts may be split along their length to relieve pressure. However, this can compromise the casts' structural integrity, predisposing fractures to loss of reduction. The goal of this study was to investigate if cast bivalving, or splitting the cast longitudinally on both sides, resulted in any immediate change to bony alignment and to assess if bivalving effected cast parameters associated with loss of reduction.
详细描述
Displaced pediatric distal radius fractures are treated with fracture reduction and cast immobilization. Currently, at our institution (and many others) radiographic assessment to determine acceptable fracture alignment and cast parameters is done immediately after cast application. However, afterward casts are often split on both sides along their length, in a process known as bivalving, prophylactically treating for post-traumatic soft tissue edema. While bivalving is felt to relieve pressure from the cast, it may also diminish the structural integrity of the cast. Although it is well-established that loss of fracture alignment is most common in the first few weeks after fracture reduction there have been no studies to evaluate any immediate changes to fracture reduction or cast parameters that may occur after bivalving. Thus, the goal of this study was to assess if pediatric distal radius fracture alignment was affected by cast bivalving by obtaining post-bivalve radiographs in addition to standard post-cast radiographs.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Guardian must be present
- •Able/eligible to complete follow-up
- •Initial injury within 72 hours
- •Distal Radius fracture with or without distal ulna fracture
- •Requiring non-operative management with molded cast
排除标准
- •Open fractures
- •Re-fractures
- •Pathologic fractures
- •Fractures associated with neurovascular injury
- •Poly trauma incident
- •Intubated patients or unable to verbalize symptoms of pain
- •Preexisting medical history that effects musculoskeletal health
结局指标
主要结局
Change in reduction after bivalving
时间窗: up to 24 hours
Change in fracture reduction of 2mm or 5 degrees in angulation on radiographs after bivalving
Cast Index
时间窗: through study completion, up to 2 years
Cast index, the ratio of sagittal to coronal width from the inside edges of the cast at the fracture site will be measured via radiographs.
Change in reduction at follow-up
时间窗: up to 30 days
Change in fracture reduction of 2mm or 5 degrees in angulation on radiographs at follow-up
Gap Index
时间窗: through study completion, up to 2 years
Gap index is a measure of space between the cast and skin measured as a ratio to the inside diameter of the cast, assessed at the level of the fracture on anteroposterior and lateral radiographs.
Three Point Index
时间窗: through study completion, up to 2 years
Three point index, a measure of space between the cast and skin at sites of the three point mold, with reference to the adequacy of reduction, assessed via the contact length of the proximal and distal fracture segments on anteroposterior and lateral radiographs.
次要结局
未报告次要终点
研究者
Daniel Cognetti
Primary Investigator
Brooke Army Medical Center