跳至主要内容
临床试验/NCT06591585
NCT06591585尚未招募不适用

Midterm Follow up of Pediatric Pelvic Fracture Management at Assiut University Hospital

Assiut University0 个研究点目标入组 65 人开始时间: 2024年10月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
65
主要终点
Modified Majeed Functional scoring system

研究概览

简要总结

Midterm radiographic and function follow up of pediatric pelvic fractures managed at Assiut University Hospital ( AUH) with a minimum of 3 years Analysis of all recorded cases of pediatric Pelvic Fracture in AUH trauma unit from 2015 until june 2024

详细描述

Pelvic fractures in children as a result of trauma are uncommon and typically follow high-energy trauma [1].

Due to flexible sacroiliac joints (SIJs) and symphysis pubis, the young pediatric skeleton has inherent flexibility, which makes pediatric pelvic fractures (PPFs) different from adult pelvic fractures . Additionally, the cartilaginous cover serves as a shock absorber. [2].

Since the young skeleton can remodel , nonsurgical therapy has been the norm for PPF; nevertheless, this has resulted in a number of long-term problems, such as nonunion, malunion, scoliosis, and pelvic asymmetry. Children with unstable pelvic fractures may experience chronic neurological impairment, low back pain, persistent pain, and limping in up to 30% of cases [2]. Several factors determine whether to treat these fractures surgically or nonsurgically: Initially, the physiological age of the patient AO/OTA classification, divides pelvic fractures into three basic types

. Type A pelvic fractures does not involve the posterior arch (stable), whereas type B results from rotational forces that cause partial posterior complex disruption (rotationally unstable). In type C, there is complete posterior complex disruption (rotationally and vertically unstable).

According to a study established by the German Trauma Society (DGU) and the German Section of the Association for Osteosynthesis /Association for the Study of Internal Fixation (AO/ASIF) International in 1991. The registry provides data on all patients suffering pelvic fractures within a 14-year time frame. They identified a total of 9684 patients including 1433 pelvic fractures in children aged ≤17 years , in pelvic factures of Type A (Tile classification of pelvic fractures), a standard mortality ratio (SMR)( The standardized mortality ratio is the ratio of observed deaths in the study group to expected deaths in the general population) of 0.76 was recorded, in Type B fractures 0.65, and in Type C fractures 0.79. [3].

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
— 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • patient age ≤17years
  • Open fracture\ Closed fractures
  • with or without neurovascular injury
  • polytrauma (including femur & tibia fracture)
  • patients who were treated conservatively (bed rest + traction)
  • patients treated surgically

排除标准

  • patients aged >17 years Isolated acetabulum Fractures Sample size calculation : Sample size was calculated using Epi- Info
  • According to results of previous study [4] , Pelvic asymmetry occurs in 9.2% of patients undergoing open reduction internal fixation . Based on this percentage, confidence limits of 5% and a confidence level of 95%, the sample needed for the study was estimated to be about 63 patients

结局指标

主要结局

Modified Majeed Functional scoring system

时间窗: base line

次要结局

未报告次要终点

研究者

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

Kirollos Raafat Ramzy Wahba

doctor

Assiut University

相似试验