Comparing Outcomes of Extended Elbow Versus Flexed Elbow Casting for Treatment of Displaced Pediatric Both Bone Forearm Fractures: A Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Alignment
研究概览
简要总结
The study design is a prospective, randomized controlled trial comparing extended elbow and flexed elbow casting. This study design will provide the highest quality evidence to investigate our primary hypothesis that extended elbow casting for proximal both bone forearm fractures will result in less loss of fracture alignment. The study population eligible for screening will be patients with open growth plates and both bone forearm fractures.
详细描述
Guardians of patients will be approached for informed consent as soon as is feasible following determination of eligibility. Injury characteristics will be obtained from the enrolling physician and the participant's medical record.
Participants will be prospectively followed at 2, 4, 6, and 24 weeks post casting. All follow-ups will occur in person in clinic and will consist of radiographs, a clinical examination and a brief interview. The follow up time points and radiographs are all part of standard clinical care. The 24 week follow up visit is an optional clinical care visit.
Study duration: 48 months; 40 month enrollment period, 6 month patient follow up and 2 month data analysis period
Sample size: 88 patients will be consented per arm.
Questionnaires: All questionnaires will take approximately 10 minutes total of the family's time. And all questionnaires for done solely for research purposes.
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
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both bone forearm fractures in which the fracture of the radius and/or ulna is located in the proximal one half of the bone
- •The fracture requires a reduction maneuver
- •All skeletally immature individuals under the age of 18
- •Patient aged greater than three years old
- •Patient or patient's consenting parent/guardian competent in English.
排除标准
- •Skeletally mature individuals
- •Both fractures are located in the distal one-half of the radius and ulna
- •Isolated fractures of the radius or ulna
- •The fracture does not require a reduction maneuver
- •Any nerve or arterial injury in the injured extremity
- •Humerus fracture on the ipsilateral side
- •Any open fracture requiring formal surgical debridement
- •Patient or patient's consenting parent/guardian not competent in English.
- •Patient or patient's consenting parent/guardian not present.
- •Severe problems with maintaining follow-up (e.g live in different state)
- •Contractures in which applying an extended elbow cast is not possible or practical
结局指标
主要结局
Alignment
时间窗: 6 weeks
To compare the proportion of proximal both bone forearm fractures that have lost alignment within 6 weeks in patients treated in a flexed elbow cast compared to those treated in an extended elbow cast.
次要结局
- Range of Motion(6 weeks and 24 weeks)
- Complication Rate(approximately 24 weeks)
- Caregiver Satisfaction Scores(6 weeks)