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临床试验/NCT06459557
NCT06459557尚未招募不适用

Management of Pediatric Distal Radius Fractures : Conservative Treatment Versus Surgical Reduction - a Randomized Controlled Trial

Assiut University0 个研究点目标入组 52 人开始时间: 2024年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
52
主要终点
mean difference of Modifed the Disabilities of the Arm, Shoulder and Hand (m-DASH) score between the two groups

研究概览

简要总结

To compare functional and radiological assessment between two groups of children with displaced distal radius fractures : those who will receive surgical reduction and those who will not.

详细描述

Distal radius fractures are the most frequent fractures seen in pediatric population accounting for about 20-30% of all fractures in children , for the non-displaced pediatric distal radius fractures , it is agreed widely to be just managed by an immobilization cast in the emergency department . However when it comes to the displaced fractures , Different centers have different options of management , mostly including either the surgical anatomical reduction under general anesthesia then casting with or without using other fixation method which is mostly k-wires , or the other option includes only casting in the emergency department without trial of reduction or just a trial of realignment under sedating agent , this second option depends on the unique phenomenon of remodeling in the pediatric fractures , as Unlike adults, in growing children, remodeling can restore the alignment of the displaced fractures to a certain extent, making anatomical reduction less essential , specially when it comes to distal radius as The distal radial and ulnar physes are responsible for about 80% of forearm length and for 40% of upper limb length that making their remodeling potential can approach upto 100% . depending on that the question was that if the fracture will be fully remodeled with no functional or range of motion disturbance on the conservative option so what the essentiality of the surgical option can be . along with exposing the child to the dangers of general anesthesia , the minor complications that can occur with k wires (as neuropraxia , pin tract infection or migration of the k wire) , emotional and financial load . in a cost analysis for different options of treatment in displaced pediatric distal radius fractures , the cost of surgical option exceeds the conservative one by multiple times . According to that a lot of the current literature have suggested to consider conservative treatment of pediatric displaced distal radius fractures to be the gold standard and fundamental option of treatment . In this study the investigators question the effectiveness of conservative treatment to displaced pediatric distal radius fractures (casting in the emergency department) in comparison to the surgical anatomical reduction in matters of functional and radiological parameters .

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
3 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • All children aged 3 to 10 years
  • both genders
  • patients presenting with displaced distal radius fractures

排除标准

  • intra articular fractures
  • Greenstick and buckle fractures
  • fractures with more than 1 week duration
  • non displaced fractures
  • Salter Harris fractures
  • open fractures
  • fractures with neurovascular bundle injury
  • poly trauma patients
  • patients with pathological bone diseases as Osteogenesis Imperfecta or CP (cerebral palsy) .
  • Galeazzi fractures

结局指标

主要结局

mean difference of Modifed the Disabilities of the Arm, Shoulder and Hand (m-DASH) score between the two groups

时间窗: 12 months

functional assessment at 1.5 , 3 , 6 and 12 months posttrauma using the Modifed the Disabilities of the Arm, Shoulder and Hand (m-DASH) score as (50/50) (100%) is considered the maximum value which is the best outcome and (10/50) (0%) is considered the minimum value which is the worst outcome

次要结局

  • Comparing palmar tilt angle between the 2 groups .(12 months)
  • Comparing radius length between the 2 groups(12 months)
  • Comparing radial inclination between the 2 groups(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Omar Hasan Mohamed

resident

Assiut University

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