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

Primary Purpose

Short Stature, Growth Disorders

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
SonicBone Ultrasound
Wrist X-ray
Sponsored by
Meir Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Short Stature focused on measuring Bone age,, Height prediction, Growth

Eligibility Criteria

42 Months - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Meir Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SonicBone Ultrasound

Arm Description

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

Outcomes

Primary Outcome Measures

bone age
Bone age in years

Secondary Outcome Measures

Full Information

First Posted
March 8, 2017
Last Updated
December 5, 2019
Sponsor
Meir Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03123003
Brief Title
Bone Age Assessment in Children Using Ultrasound Compared to Wrist X-ray
Official Title
Bone Age Assessment in Children Using Ultrasound Compared to Wrist X-ray
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
March 31, 2020 (Anticipated)
Study Completion Date
June 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meir Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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: speed of propagation through bone (speed-of-sound, SOS, m/sec) of inaudible high frequency waves of a short ultrasound pulse; and 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Short Stature, Growth Disorders
Keywords
Bone age,, Height prediction, Growth

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SonicBone Ultrasound
Arm Type
Experimental
Arm Description
Assessment of bone age by SonicBone Ultrasound will compared to wrist X-ray assessment
Intervention Type
Device
Intervention Name(s)
SonicBone Ultrasound
Intervention Description
Bone age assessment by SonicBone Ultrasound. The patient needs to put his/her wrist in 3 positions.
Intervention Type
Device
Intervention Name(s)
Wrist X-ray
Intervention Description
Bone age assessment by Wrist X-ray
Primary Outcome Measure Information:
Title
bone age
Description
Bone age in years
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
42 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alon Eliakim, Prof.
Phone
972-9-7471596
Email
Eliakim.Alon@clalit.org.il
First Name & Middle Initial & Last Name or Official Title & Degree
Dan Nemet, Prof.
Phone
972-9-7471596
Email
Dan.Nemet@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alon Eliakim, Prof.
Organizational Affiliation
Meir Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Meir Medical Center
City
Kfar Saba
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michal Pantanowitz, PhD
Phone
972-9-7471596
Email
michalmirochnik@gmail.com
First Name & Middle Initial & Last Name & Degree
Alon Eliakim, Prof.
First Name & Middle Initial & Last Name & Degree
Dan Nemet, Prof.
First Name & Middle Initial & Last Name & Degree
Michal Pantanowitz, PhD
First Name & Middle Initial & Last Name & Degree
Nitzan Dror, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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