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Ultrasound Evaluation of Bone Age in Healthy Children

NCT01980693 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2015-03-06

No results posted yet for this study

Summary

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.

Conditions

  • Evaluation of Bone Age by Ultrasound Technology

Interventions

DEVICE

SonicBone ultrasound

The device measure BA using ultrasound technology by measurement of speed of sound in three different sites : wrist bones, Phalanx III, Metacarpal bones.The device sends a short US pulse and measures the distance between a transmitter probe and a receiver probe, located at the bone measured area.The US probe converts electrical pulse to US pulse and US wave via tested bone arrives from transmitter to Receiver. Simultaneously with US pulse, controller start timer to calculate time between US pulse and the moment that US wave arrives to receiver. The accepted US signal of selected probe via amplifiers arrives to comparators that read timer value. The microcontroller calculates SOS using distance between probes and US time of flight.

Sponsors & Collaborators

  • Clalit Health Services

    lead OTHER

Principal Investigators

  • Herman Av Cohen, MD · Clalit Health Services

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01980693 on ClinicalTrials.gov