Bone Age Assessment in Children Using Ultrasound Compared to Wrist X-ray
1 other identifier
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 8, 2017
CompletedFirst Posted
Study publicly available on registry
April 21, 2017
CompletedStudy Start
First participant enrolled
June 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedDecember 9, 2019
December 1, 2019
2.8 years
March 8, 2017
December 5, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
bone age
Bone age in years
through study completion, an average of 1 year
Study Arms (1)
SonicBone Ultrasound
EXPERIMENTALAssessment of bone age by SonicBone Ultrasound will compared to wrist X-ray assessment
Interventions
Bone age assessment by SonicBone Ultrasound. The patient needs to put his/her wrist in 3 positions.
Eligibility Criteria
You may qualify if:
- Children 3.5-18 years old refered to the endocrine pediatric clinic due to short stature or other growth abnormalities
You may not qualify if:
- Children with bone disease
- Children who within the last year took medications which might change bone metabolism or mineralization
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Meir Medical Center
Kfar Saba, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alon Eliakim, Prof.
Meir Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2017
First Posted
April 21, 2017
Study Start
June 1, 2017
Primary Completion
March 31, 2020
Study Completion
June 1, 2020
Last Updated
December 9, 2019
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will not share