Evaluation of Bone Age by Ultrasound Technology Clinical Trial
Official title:
Cohort Study to Investigate the Relationship Between Ultrasound Apparatus Results (SonicBone's BAUS) and Skeletal Maturity Status (Bone Age) Among Healthy Children and Adolescence
Skeletal maturity assessment, defined also as bone age (BA), has an important role in
pediatrics and pediatric endocrinology, used mainly for evaluating growth and puberty
related endocrine disorders. Repeated BA assessment is important during the follow up of
children with short stature, with precocious puberty and those treated by growth promoting
medications.
The most commonly used method used for determining skeletal maturity, and thus BA is based
on comparison of a hand and wrist radiographs to a standard series of representative films
in the "Radiographic atlas of skeletal development of the hand and wrist" by Greulich and
Pyle (GP), which has been issued several decades ago. The suggested method in this study is
based on ultrasound technology, and therefore it is quick, objective, and radiation-free. It
delivers an immediate non biased result without the need to rely on an observer's evaluation
of the hand radiograph and without the need for a specialized radiology facility.
Skeletal maturity assessment, defined also as bone age (BA), has an important role in
pediatrics and pediatric endocrinology, used mainly for evaluating growth and puberty
related endocrine disorders. Repeated BA assessment is important during the follow up of
children with short stature, with precocious puberty and those treated by growth promoting
medications.
The most commonly used method used for determining skeletal maturity, and thus BA is based
on comparison of a hand and wrist radiographs to a standard series of representative films
in the "Radiographic atlas of skeletal development of the hand and wrist" by Greulich and
Pyle (GP), which has been issued several decades ago. Among the disadvantages and drawbacks
in this BA assessment method are: the obligatory need for using radiology units that are
often available only in special facilities or hospitals, not available at the physicians
office, the exposure to ionizing radiation, and the known limitation of the method for the
need of an endocrinologist to assess the BA, with a known large inter observers variability
of the BA interpretation.
The suggested method in this study is based on ultrasound technology, and therefore it is
quick, objective, and radiation-free. It delivers an immediate non biased result without the
need to rely on an observer's evaluation of the hand radiograph and without the need for a
specialized radiology facility.
This technique was innovated in order to find an efficient, convenient and non radiation
based method of skeletal maturity assessment for the primary care physician that can be
performed in an office setting.
The aim of this study is to establish a new bone age database by an ultrasound apparatus
(SonicBone) that will eventually replace the X-ray based assessment using Greulich and Pyle
and Tanner & Whitehouse Atlas and methods.
The design of the study is to perform a concomitant skeletal maturation assessment by
reading of an ultrasound technique using the SonicBone apparatus. Skeletal maturation
assessment will be performed in females and males at various age groups from 4-17 years old.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic