Bone Age Assessment in Children Using Ultrasound Compared to Wrist X-ray
NCT ID: NCT03123003
Last Updated: 2019-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
300 participants
INTERVENTIONAL
2017-06-01
2020-06-01
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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SonicBone Ultrasound
Assessment of bone age by SonicBone Ultrasound will compared to wrist X-ray assessment
SonicBone Ultrasound
Bone age assessment by SonicBone Ultrasound. The patient needs to put his/her wrist in 3 positions.
Wrist X-ray
Bone age assessment by Wrist X-ray
Interventions
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SonicBone Ultrasound
Bone age assessment by SonicBone Ultrasound. The patient needs to put his/her wrist in 3 positions.
Wrist X-ray
Bone age assessment by Wrist X-ray
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Children who within the last year took medications which might change bone metabolism or mineralization
42 Months
18 Years
ALL
Yes
Sponsors
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Meir Medical Center
OTHER
Responsible Party
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Principal Investigators
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Alon Eliakim, Prof.
Role: PRINCIPAL_INVESTIGATOR
Meir Medical Center
Locations
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Meir Medical Center
Kfar Saba, , Israel
Countries
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Central Contacts
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Facility Contacts
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Michal Pantanowitz, PhD
Role: primary
Other Identifiers
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MeirMc0042-17CTIL
Identifier Type: -
Identifier Source: org_study_id