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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03123003
Enrollment
300
Registered
2017-04-21
Start date
2017-06-01
Completion date
2020-06-01
Last updated
2019-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Growth Disorders, Short Stature

Keywords

Bone age,, Height prediction, Growth

Brief summary

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.

Detailed description

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.

Interventions

Bone age assessment by SonicBone Ultrasound. The patient needs to put his/her wrist in 3 positions.

DEVICEWrist X-ray

Bone age assessment by Wrist X-ray

Sponsors

Meir Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
42 Months to 18 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
bone agethrough study completion, an average of 1 yearBone age in years

Countries

Israel

Contacts

Primary ContactAlon Eliakim, Prof.
Eliakim.Alon@clalit.org.il972-9-7471596
Backup ContactDan Nemet, Prof.
Dan.Nemet@clalit.org.il972-9-7471596

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026