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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.
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.
Age
3 - 18 years
Sex
ALL
Healthy Volunteers
Yes
Meir Medical Center
Kfar Saba, Israel
Start Date
June 1, 2017
Primary Completion Date
March 31, 2020
Completion Date
June 1, 2020
Last Updated
December 9, 2019
300
ESTIMATED participants
SonicBone Ultrasound
DEVICE
Wrist X-ray
DEVICE
Lead Sponsor
Meir Medical Center
NCT06662045
NCT05382637
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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View ClinicalTrials.gov Terms and ConditionsNCT05894876