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临床试验/NCT04746417
NCT04746417已完成不适用

Validation of the Assessment of Skeletal Maturity Using Femoral Head in Patients With Idiopathic Scoliosis and Its Clinical Implications

The University of Hong Kong2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2021年2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
70
试验地点
2
主要终点
PFEO stages

研究概览

简要总结

This study aims to explore the use of proximal femoral head for the assessment of skeletal maturity in patients with idiopathic scoliosis. The aim is to validate the use of the stages of proximal femoral epiphyseal closure in assessing pubertal growth landmarks in this patient cohort. The grading system of this skeletal maturity index will be established and its reliability and reproducibility in clinical use will be examined.

详细描述

There are multiple skeletal maturity measures currently in use which were established with reliability in assessing growth. The advantages and shortcomings of each index was previously examined. This study aims to explore the use of proximal femoral epiphysis, which is in close proximity of the radiographic field of the spine, in assessing the growth status of patients with idiopathic scoliosis. The stages of the proximal femoral epiphyseal ossification has been established with specific definitions. The reliability and reproducibility of using these gradings will be examined by orthopaedic surgeons. Subsequently, the assessment of different pubertal growth landmarks using these gradings will be validated, and to see whether these gradings can provide indications of peak growth and growth cessation. Finally, the relationships of such growth assessment using this proximal femoral epiphysis ossification (PFEO) system and the curve progression in idiopathic scoliosis will be studied.

研究设计

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

入排标准

年龄范围
6 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Idiopathic scoliosis
  • Open triradiate cartilage or open distal radius epiphysis without capping

排除标准

  • Non-idiopathic scoliosis
  • Patients with growth hormone deficiency or developmental delay
  • Patient has not reached skeletal maturity
  • Defaulted and lost to follow-up

结局指标

主要结局

PFEO stages

时间窗: 8 to 18 years

Grade 1 to Grade 6

次要结局

  • Growth parameters(8 to 18 years)

研究者

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

Dr. Jason Pui Yin Cheung

Clinical Associate Professor

The University of Hong Kong

研究点 (2)

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