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

Sponsor
Meir Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT03123003
Collaborator
(none)
300
1
1
36
8.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: SonicBone Ultrasound
  • Device: Wrist X-ray
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Bone Age Assessment in Children Using Ultrasound Compared to Wrist X-ray
Actual Study Start Date :
Jun 1, 2017
Anticipated Primary Completion Date :
Mar 31, 2020
Anticipated Study Completion Date :
Jun 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: SonicBone Ultrasound

Assessment of bone age by SonicBone Ultrasound will compared to wrist X-ray assessment

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

Device: Wrist X-ray
Bone age assessment by Wrist X-ray

Outcome Measures

Primary Outcome Measures

  1. bone age [through study completion, an average of 1 year]

    Bone age in years

Eligibility Criteria

Criteria

Ages Eligible for Study:
42 Months to 18 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Meir Medical Center Kfar Saba Israel

Sponsors and Collaborators

  • Meir Medical Center

Investigators

  • Principal Investigator: Alon Eliakim, Prof., Meir Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT03123003
Other Study ID Numbers:
  • MeirMc0042-17CTIL
First Posted:
Apr 21, 2017
Last Update Posted:
Dec 9, 2019
Last Verified:
Dec 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Meir Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 9, 2019