The Optimized Follow-up Protocol for Pediatric Metaphyseal Forearm Fractures
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- loss of reduction rate
研究概览
简要总结
The randomized controlled study which compare radiologic outcomes (loss of reduction rate) and complications in pediatric patients with displaced metaphyseal forearm fractures who underwent conservative treatment. The patients were assigned in two different follow-up protocols. In the control group, the patients will go to hospital for follow-up visit and film every week until 4th week after injury. In the intervention group, the patients will go to hospital for follow-up visit every week except in the 3rd week after injury they will be gotten telemedicine follow-up.
详细描述
Randomization of patients for 2 different follow-up protocols
Objective: to compare loss of reduction rate by angulation measurement and prevalence of complications in patients with displaced metaphyseal forearm fractures who underwent conservative treatment.
Method:
Patients will be randomly assigned to one of two groups using various block computerized randomization. Randomization will be performed using STATA version 16.0, Statacorp, College Station, Texas, USA
Interventions:
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 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 0-12 years
- •Patients with distal metaphyseal forearm fractures in Ramathibodi hospital and Chakri Naruebodindra Medical Institute
- •Presented to hospital within 72 hours of injury
排除标准
- •Open fracture
- •Operative treatment at 1st visit
- •Neurovascular injury
- •Polytraumatized patient
- •Ipsilateral fracture of upper limb
- •History of previous surgery in the affected arm
- •Metabolic bone disease
结局指标
主要结局
loss of reduction rate
时间窗: From enrollment to the end of treatment at 4 weeks
Angulation is more than 10 degree in coronal view or more than 20 degree in sagittal view
次要结局
- Complications(From enrollment to the end of treatment at 4 weeks)
研究者
Nonticha Thanthong
Sponsor Investigator
Ramathibodi Hospital