跳至主要内容
临床试验/NCT03689959
NCT03689959已完成不适用

Correction of Fixed Knee Flexion Deformity in Children Using Eight-plate Hemiepiphysiodesis

Assiut University2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2018年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
23
试验地点
2
主要终点
Degree of flexion deformity

研究概览

简要总结

The study aims to assess the effectiveness of hemiephysiodesis using eight plates in correction of fixed knee flexion deformities in children.

详细描述

Flexion contractures of the knee are quite disabling. They produce deleterious effects on knee biomechanics, quadriceps function, energy expenditure during gait and the overall ability to ambulate. These deformities occur secondary to a number of different etiologies including; congenital, traumatic, inflammatory and neuromuscular disorders with cerebral palsy (CP) being on the top of the list.

The main aim of correction of sagittal plane deformities of the knee is to restore the range of motion. Surgical options available for correction of knee flexion contractures include soft tissue modification, acute correction by osteotomies, gradual correction by external fixators and growth modulation by hemiephysiodesis.Extensive soft tissue surgery may be needed for correction of knee deformities with potential risk of neurovascular damage and wound complications. Supracondylar extension osteotomies have been widely used, however prolonged immobilization and associated neurovascular insults have always been major concerns. External fixators are cumbersome and may produce muscle tethering and pin tract infections.

There are few studies in the literature reporting the use of anterior hemiepiphysiodesis for correction of knee flexion contracture.

Our study question can be summarized as follows; Is hemiepiphysiodesis by eight plates effective for correction of fixed knee flexion deformities in children ?

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
4 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Fixed knee flexion deformity more than 10°
  • Unilateral or bilateral cases
  • 12 months or more predicted growth remaining
  • No response to non-operative treatment (physical therapy, bracing, casting);
  • Recurrent cases

排除标准

  • Dynamic deformities due to spasticity
  • Deformities responding to conservative treatment

结局指标

主要结局

Degree of flexion deformity

时间窗: One year

The angle between the anterior borders of thigh and leg measured clinically with a goniometer

次要结局

  • Complications(One year)
  • Rate of correction(One year)

研究者

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

Mohamed Yahya Abdel Azeem Hassanein

Principal Investigator

Assiut University

研究点 (2)

Loading locations...

相似试验