跳至主要内容
临床试验/NCT05334862
NCT05334862招募中不适用

Residual Torsional Deformity in Pediatric Genu Varum After Coronal Plane Deformity Correction by 8 Plate Hemi Epiphysiodesis.

Assiut University1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2025年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
15
试验地点
1
主要终点
residual torsional deformity measured via clinical examination.

研究概览

简要总结

This study is to evaluate the residual torsional deformity in pediatric Genu Varum after coronal plane deformity correction by 8 plate hemi epiphysiodesis.

详细描述

Angular deformities around the knee in children is a common finding including genu valgum and genu varum.

The genu valgum or varum may be idiopathic or arise from diverse etiologies, such as trauma, dysplasia, metabolic disease, inflammatory, endocrine, tumor, neoplastic, or developmental pathologies.

Surgical treatment options include osteotomies with either acute or gradual correction and temporary hemi epiphysiodesis (guided growth),the latter being less invasive and with significantly lower rate of major complications.

Guided growth by 8 plate hemi epiphysiodesis is commonly used to correct coronal plane deformity around the knee. Since its introduction by Stevens in 2007 many studies have demonstrated the efficacy, safety and advantages of tension band plating in the paediatric age group as an alternative to corrective osteotomy.

Genu varum deformities of the leg are often associated with internal tibial torsion. The 3 major causes of pediatric in-toeing are metatarsus adductus, internal tibial torsion, and femoral anteversion.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
30 Months 至 12 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Inclusion criteria: skeletally immature patients over 2.5 years of age and less than 12 years of age who presented with genu varum. (unilateral or bilateral)

排除标准

  • •skeletal maturity.
  • •epiphyseal dysplasia.
  • •metabolic and neurologic disorders.
  • •previous trauma.
  • •patients younger than 2.5 years and older than 12 years old

研究组 & 干预措施

skeletally immature patients between 2.5 : 12 years with genu varum

Active Comparator

skeletally immature patients over 2.5 years of age and less than 12 years of age who presented with genu varum. (unilateral or bilateral) ..those will be treated by 8 plate hemi epiphysiodesis.

干预措施: 8 plate hemiepiphysiodesis (Procedure)

结局指标

主要结局

residual torsional deformity measured via clinical examination.

时间窗: 1 year

clinical examination by measuring : thigh foot angle - foot progression angle - heel bisector - internal and external rotaion of the hip

次要结局

  • Any complications detected(1 year)

研究者

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

Andrew Nasseh Hafeez Boles

Resident doctor, Orthopaedic surgery department, Principal investigator

Assiut University

研究点 (1)

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