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临床试验/NCT03123003
NCT03123003Unknown不适用

Bone Age Assessment in Children Using Ultrasound Compared to Wrist X-ray

Meir Medical Center1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2017年6月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
300
试验地点
1
主要终点
bone age

研究概览

简要总结

Bone age assessment in children is based on the interpretation of hand x-ray scans according to Greulich and Pyle (GP) standard atlas and frequently used for evaluating growth and puberty in children and adolescents.

To address the disadvantage of repeated irradiation, the need for specialized radiation centers, heavy equipment and subjective reading a new device, SonicBone was developed. SonicBone utilizes a quantitative ultrasonographic technology of ultrasonic (US) waves, propagating along a measured bone distance. The aim of the study is to evaluate an ultrasound based device, SonicBone, compared to the current method in children. The investigators will be compared the US assessment to available bone age X-ray that exists in the medical files of the patients. The investigators will not do bone age X-ray scans especially for the current study.

详细描述

Bone age assessment in children is based on the interpretation of hand x-ray scans according to Greulich and Pyle standard atlas and frequently used for evaluating growth and puberty in children and adolescents.

To address the disadvantage of repeated irradiation, the need for specialized radiation centers, heavy equipment and subjective reading a new device, SonicBone was developed. SonicBone utilizes a quantitative ultrasonographic technology of ultrasonic (US) waves, propagating along a measured bone distance. The aim of the study is to evaluate the ultrasound based device, SonicBone, and to compare it to the current method used in children.

The SonicBone device (Rishon Lezion, Israel) is a small (50cm X 25cm X 25cm), portable, bone sonometer, which measures two parameters:

  1. speed of propagation through bone (speed-of-sound, SOS, m/sec) of inaudible high frequency waves of a short ultrasound pulse; and
  2. attenuation (ATN; the decay rate) of the sound wave by the bone as a function of the distance it travels between a transmitter probe and a receiver probe15. The hand is measured by: 1- wrist (W), measuring SOS and ATN at the distal radius and ulna secondary ossification centers of the epiphyses; 2-metacarpals (MC), measuring SOS and ATN at the distal metacarpal epiphyses; and 3- phalange (P), measuring SOS and ATN along the bent proximal third phalanx shaft, growth plate and epiphysis. The average of those 3 readings is define as the child's bone age by SonicBone. All ultrasonic examinations will be conducted at the Pediatric Endocrinology Clinic, by a trained technician.

X-ray scans will be evaluated independently by a pediatric endocrinologist according to the GP atlas.

研究设计

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

入排标准

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

入选标准

  • Children 3.5-18 years old refered to the endocrine pediatric clinic due to short stature or other growth abnormalities

排除标准

  • Children with bone disease
  • Children who within the last year took medications which might change bone metabolism or mineralization

结局指标

主要结局

bone age

时间窗: through study completion, an average of 1 year

Bone age in years

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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