The Validity of Bone Age Assessment by an Ultrasound Apparatus (SonicBone)

NCT01346618 | Completed

• 1 other identifier: 11/11
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Bone age assessment is currently an important tool in final height implication in children. It is an important tool in the phases of investigation and treatment of short stature, tall stature, pubertal timing and various endocrinological pediatric situations. It is currently assessed using hand x-ray. This method has several limitations, including: requirement of specialized medical staff to interpret results, exposure radiation and usage of equipment which is only in radiology centers. The investigators aim to study a new equipment, radiation free, with simple and swift operation which provides an immediate answer, no need for an experienced observer, a mobile equipment with easy accessibility. The aim of the study is to assess its reproducibility, validity and safety compared to the x-ray method. The investigators hypothesize it is as accurate and valid.

Conditions

Bone Age

Keywords

bone age; children; x-ray; ultrasound; ultrasound based method; safe; valid; reproducable

Outcome Measures

Primary Outcomes (1)

• BA assessment readings by the SonicBone's BA device compared to the traditional GP method based reading of left hand x-ray and their reproducibility

  9 months

Secondary Outcomes (1)

• The number of participants experiencing adverse side affects

  9 months

Study Arms (1)

children ages 4-17 years

Participants are children and youth ages 4-17 years (inclusive) who performed or will perform a X-ray of the left hand for bone age assessment as part of any clinical work up, within 2 months of enrollment in this study.

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Participants are children and youth ages 4-17 years (inclusive) who performed or will perform a X-ray of the left hand for bone age assessment as part of any clinical work up, within 2 months of enrollment in this study. Participants will be recruited according to advertising the study amongst pediatricians, pediatric endocrinologists and from the pediatric population who visits the pediatric endocrine clinic, endocrine testing room, adolescent medicine clinic, or being hospitalized at the pediatric division, Assaf Haroffeh Medical Center.

You may qualify if:

• Children aged 4-17 years old
• Children who performed or will perform a hand x-ray as part of their clinical work up within 2 months from study enrolment
• A signed Informed Consent Form that was obtained from at least one parent or legal guardian and an audio approval by the other (phone call), if available, prior to ultrasound study.
• An assent from the child to perform the SonicBone's BA device reading

You may not qualify if:

• Children taking any medication that might change bone metabolism or mineralization within the last year (glucocorticosteroids, sex steroids, oral contraceptives, anticonvulsants, calcium and vitamin D in superphysiological doses)
• Children with suspected bone diseases or multiple fractures.

Sponsors & Collaborators

• Assaf Harofeh MC: lead

Study Sites (1)

Assaf Haroffeh Medical Center

Ẕerifin, 70300, Israel

Location

Study Officials

• Marianna Rachmiel, MD

  Assaf Haroffeh Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Marianna Rachmiel

Study Record Dates

• First Submitted: April 25, 2011
• First Posted: May 3, 2011
• Study Start: May 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: December 6, 2022

Record last verified: 2022-12

Locations

IL (1)