Long Arm Vs Short Arm Fiberglass Cast for Treatment of Displaced Distal Radius Fractures: A Multi-Center Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Patients requiring repeat intervention due to loss of alignment
研究概览
简要总结
The aim of the study is to determine by multicenter randomized controlled trial whether short arm fiberglass casts are as effective as long arm casts for immobilizing displaced pediatric distal third forearm fractures that have undergone closed reduction.
The primary outcome is loss of reduction requiring cast wedging, recasting, repeat reduction, or surgical intervention.
Secondary outcomes will include Patient Reported Outcome Measures for physical function, such as Pedi-FABS, PROMIS (Patient Reported Outcomes Measurement Information System) Upper Extremities , and UCLA (University of California Los Angelos) Activity Scale, and pain/comfort levels,such as PROMIS Pediatric Pain Interference, PROMIS Pediatric Pain Intensity, and VAS ( Visual Analogue Scale) comfort in cast. In addition, secondary outcomes include complications (skin irritation, compartment syndrome, elbow stiffness, cast saw burns etc). The investigators will assess potential risk factors for loss of reduction including initial displacement, level of fracture (physeal, metaphyseal, meta-diaphyseal), initial translation, initial angulation, age, sex, cast index, padding index, adequacy of initial reduction, and provider level of training.
详细描述
The most common type of fracture in pediatric patients is the distal third forearm fracture, with over 600,000 cases in the in the United States each year. Traditionally long arm casts have been used for displaced distal forearm fractures, but it may be the case that short arm casts are sufficient. Three RCTs (Randomized Control Trials) have been performed comparing the efficacy of plaster short and long arm casts for displaced distal forearm fractures; these studies have shown no significant difference in angulation or displacement. If short and long arm casts offer comparable stability, the short arm version would likely be desirable as patient satisfaction and cost effectiveness are improved with short arm casts.
Despite the results of three well-executed RCTs, it is still common practice for long arm casts to be applied for distal forearm fractures. Many surgeons continue to recommend that their residents apply long arm casts for all displaced forearm fractures, including distal third fractures. At NYP (New York Presbyterian) Cornell and NYP Queens, residents routinely apply long arm casts for all forearm fractures.
Long arm casts are more likely to result in elbow stiffness, although this is often a temporary complication. Long arm casts also require more material and take longer to apply or remove, potentially leading to higher treatment costs. Additionally, when a longer cast is worn there is a larger distance where a cast burn could occur. Skin irritation, particularly at the cubital fossa, is likely more common with a long arm cast, and they are overall less comfortable, due to elbow restriction and a heavier weight.
Short arm casts that are well molded to the arm's contours have been shown to control forearm supination and pronation. A low cast index has been shown to significantly increase the rate of fracture redisplacement. The cast index determines the quality of cast molding, and is measured by dividing the sagittal width of the cast by the coronal width. Substantial changes in cast angulation have been attributed to poor cast-molding and a low cast index. The results suggested that short arm casts when appropriately molded can be effective in treating fractures of the distal third of the forearm.
If short arm casts are equivalent in providing stability for distal third forearm fractures, providers should be using them preferentially to avoid the potential complications of elbow stiffness, cast burn, skin irritation, and patient dissatisfaction. However, surgeons persist with using long arm casts. Rationale for the persistent use of long arm cast is believed to include anecdotal concerns of residents placing inadequate short arm casts, leading to an increased risk for translation or angulation requiring recasting.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 4-12 years of age
- •Displaced distal third forearm fracture (physeal, metaphyseal, meta-diaphyseal) requiring closed reduction
- •Displacement must be: For children 4-9: angulation >30 degrees and/or 100% translation on either AP (anteroposterior) or lateral view. For children 10-12: angulation > 15 degrees and/or >50% translation on either AP or lateral view
排除标准
- •Patients undergoing additional orthopedic procedures at the time closed reduction of distal arm fracture
- •Patient with a presenting open fracture
- •A known pathologic fracture
- •Patient with a refracture through pre-existing fracture lines
- •Patients with compartment syndrome or neuropathy
研究组 & 干预措施
Long Arm Fiberglass Cast
Conscious sedation will be provided to patient while the reduction is performed by a cast trained orthopedic resident using standard techniques under fluoroscopic guidance. The arm will be held by an assistant or finger traps in the absence thereof. The arm will not be suspended until after the manipulation is performed. A stockingette and webril will first be applied, after which the short arm fiberglass portion of the cast will be applied. After short arm casting has been appropriately placed, randomization group will be revealed. Casting will be extended to the shoulder joint if the patient is assigned to the long arm cast group. The mold will then be applied and cast construct will be bivalved and taped.
干预措施: Closed Reduction (Procedure)
Long Arm Fiberglass Cast
Conscious sedation will be provided to patient while the reduction is performed by a cast trained orthopedic resident using standard techniques under fluoroscopic guidance. The arm will be held by an assistant or finger traps in the absence thereof. The arm will not be suspended until after the manipulation is performed. A stockingette and webril will first be applied, after which the short arm fiberglass portion of the cast will be applied. After short arm casting has been appropriately placed, randomization group will be revealed. Casting will be extended to the shoulder joint if the patient is assigned to the long arm cast group. The mold will then be applied and cast construct will be bivalved and taped.
干预措施: Long Arm Fiberglass Cast (Other)
Short Arm Fiberglass Cast
Conscious sedation will be provided to patient while the reduction is performed by a cast trained orthopedic resident using standard techniques under fluoroscopic guidance. The arm will be held by an assistant or finger traps in the absence thereof. The arm will not be suspended until after the manipulation is performed. A stockingette and webril will first be applied, after which the short arm fiberglass portion of the cast will be applied. After short arm casting has been appropriately placed, randomization group will be revealed. Casting will be complete at this point if the patient is assigned to the short arm cast group. The mold will then be applied and cast construct will be bivalved and taped.
干预措施: Closed Reduction (Procedure)
Short Arm Fiberglass Cast
Conscious sedation will be provided to patient while the reduction is performed by a cast trained orthopedic resident using standard techniques under fluoroscopic guidance. The arm will be held by an assistant or finger traps in the absence thereof. The arm will not be suspended until after the manipulation is performed. A stockingette and webril will first be applied, after which the short arm fiberglass portion of the cast will be applied. After short arm casting has been appropriately placed, randomization group will be revealed. Casting will be complete at this point if the patient is assigned to the short arm cast group. The mold will then be applied and cast construct will be bivalved and taped.
干预措施: Short Arm Fiberglass Cast (Other)
结局指标
主要结局
Patients requiring repeat intervention due to loss of alignment
时间窗: Up to 7 months
Proportion of patients requiring repeat intervention (cast wedging, recasting, or surgical intervention) following short arm vs long arm cast application.
次要结局
- Comfort assessed by patient reported outcomes - Scale(1 week +/- 5 days visit, 3 weeks +/- 1 week, 6 weeks +/- 1 week, 3 months +/- 2 weeks , 6 months +/- 4 weeks)
- Number of Participants with complications(1 week +/- 5 days visit, 3 weeks +/- 1 week, 6 weeks +/- 1 week, 3 months +/- 2 weeks , 6 months +/- 4 weeks)
- Pain assessed by patient reported outcomes - Surveys(1 week +/- 5 days visit, 3 weeks +/- 1 week, 6 weeks +/- 1 week, 3 months +/- 2 weeks , 6 months +/- 4 weeks)
- Physical function assessed by patient reported outcomes - Surveys(1 week +/- 5 days visit, 3 weeks +/- 1 week, 6 weeks +/- 1 week, 3 months +/- 2 weeks , 6 months +/- 4 weeks)