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临床试验/NCT07548749
NCT07548749尚未招募不适用

Management of Coronal Deformities Around the Knee With Hemiepiphysiodesis Using Transphyseal Screws Versus Eight Plates , Short Term Results

Sohag University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年5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
尚未招募
入组人数
60
试验地点
1
主要终点
correction of deformity

研究概览

简要总结

Coronal angular deformities of the lower limbs, such as bow legs and knock-knees, are frequently observed in childhood. While many cases are considered normal and resolve on their own, when these deformities become significant and progressive, they can disrupt the quality of life, leading to gait disturbances, pain, and in severe instances, joint instability. Additionally, these deformities may have indirect effects on other joints like the hip and ankle, and most importantly, they increase the risk of early osteoarthritis in the knee .

It is generally accepted that a significant deformity that persists up to preadolescence will not correct spontaneously. Physiological alignment of the lower limb is crucial for the symmetrical distribution of weight over the surfaces of the joints, especially the knee. Indeed, severe coronal malalignment has been linked to knee pain, altered gait, and occasionally patellofemoral problems .

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 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Both gender (males and females)
  • Children ≥3 years old and growing children 2 years at least remaining in growth ( skeletal immature)
  • Cases with progressive knee deformities around knee at any side.

排除标准

  • 1. Physeal closure.
  • 2. Physiological deformity in younger ages that could be managed conservatively ( age < 3 years )
  • 3. Cases with metabolic or chronic illness conditions unresolved.

研究组 & 干预措施

Go for transphyseal screws

Active Comparator

干预措施: hemiepiphysiodesis (Procedure)

Go for eight plates

Active Comparator

干预措施: hemiepiphysiodesis (Procedure)

结局指标

主要结局

correction of deformity

时间窗: 6 months after surgery

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

Hossam Hosny Omar

Hossam hosny omar mansour

Sohag University

研究点 (1)

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