Validation Sonic Bone's Ultrasound System for Bone Age Assessment
BAUS
1 other identifier
interventional
416
1 country
1
Brief Summary
The selection of talents in junior sports is strongly influenced by the current physical conditions of the athletes. However, the physical abilities, for example in junior football, are largely dependent on the maturation and show a high degree of variability during puberty. For example, the maturity status in an U14 football team fluctuates by up to 5 years between early and late developed players. It is necessary to include the maturation in junior sports in selections in order to give all athletes the same chance of selection regardless of their maturity status. This will make selections fairer and the promotion of athletes with the highest potential will be better implemented. Bone age is considered to be an objective indicator of the maturation. For this purpose, a practicable and preferably radiation-free method for determining bone age is needed. A new medical device promises to determine bone age based on ultrasound technology. This now offers the chance to switch to a significantly less stressful technique. The aim of the study is to determine the quality criteria (validity and reliability) of this new method in order to decide whether the current gold standard of the X-ray method could be replaced by a less stressful method.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2020
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 5, 2020
CompletedFirst Posted
Study publicly available on registry
March 10, 2020
CompletedStudy Start
First participant enrolled
May 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2021
CompletedMarch 10, 2020
March 1, 2020
7 months
March 5, 2020
March 9, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Bone Age Assessment using Ultrasound
The bone age is determined by the use of the new medical device according to the instructions for use.
20 minutes
Bone Age Assessment by imaging method using X-Ray
The gold standard is the determination of bone age according to the Tanner \& Whitehouse (TW2) method using an X-ray image of the hand bone and subsequent calculation based on standardized comparison images (Tanner et al., 1975).
20 minutes
Study Arms (2)
Ultrasound
OTHERThe intervention measurement is the determination of bone age using the ultrasound device.
XR
OTHERThe control measurement is the determination of the bone age by the imaging method using X-rays.
Interventions
The measurement of bone age is performed via ultrasound with the "Ultrasound System for Bone Age Assessment (BAUS)" from Sonic Bone (SonicBone Medical Ltd., Rishon Lezion, Israel).
The measurement of bone age is performed via imaging procedure via X-ray (Röntgengerät, Stadler SE 4600, Littau, CH) of the left hand.
Eligibility Criteria
You may qualify if:
- Age between 10-18
- healthy
- voluntary participation
- consent of the participant or legal representative to participate in the project
- active in a sports club
You may not qualify if:
- pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Swiss Federal Instistiution of Sport
Magglingen, Switzerland
Related Publications (4)
Malina RM, Cumming SP, Kontos AP, Eisenmann JC, Ribeiro B, Aroso J. Maturity-associated variation in sport-specific skills of youth soccer players aged 13-15 years. J Sports Sci. 2005 May;23(5):515-22. doi: 10.1080/02640410410001729928.
PMID: 16194999BACKGROUNDMalina RM, Rogol AD, Cumming SP, Coelho e Silva MJ, Figueiredo AJ. Biological maturation of youth athletes: assessment and implications. Br J Sports Med. 2015 Jul;49(13):852-9. doi: 10.1136/bjsports-2015-094623.
PMID: 26084525BACKGROUNDMalina RM, Coelho E Silva MJ, Figueiredo AJ, Carling C, Beunen GP. Interrelationships among invasive and non-invasive indicators of biological maturation in adolescent male soccer players. J Sports Sci. 2012;30(15):1705-17. doi: 10.1080/02640414.2011.639382. Epub 2012 Feb 3.
PMID: 22304621BACKGROUNDTanner, J. M., Whitehouse, R., Cameron, N., Marshall, W., Healy, M., & Goldstein, H. (1975). Assessment of skeletal maturity and prediction of adult height (TW2 method) (Vol. 16): Academic Press London.
BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jon Wehrlin, Dr. scient.
Responsible for R+D
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2020
First Posted
March 10, 2020
Study Start
May 1, 2020
Primary Completion
December 1, 2020
Study Completion
July 1, 2021
Last Updated
March 10, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share