Clinical trial NCT04301570: Validation Sonic Bone's Ultrasound System for Bone Age Assessment
Official title: Validation Sonic Bone's Ultrasound System for Bone Age Assessment (BAUS)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bone Age Assessment
Lead sponsor: Swiss Federal Institute of Sport Magglingen
Sponsor class: OTHER_GOV
First posted: 2020-03-10
Enrollment: 416
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


Eligibility criteria: Inclusion Criteria:

* Age between 10-18
* healthy
* voluntary participation
* consent of the participant or legal representative to participate in the project
* active in a sports club

Exclusion Criteria:

* pregnancy

Primary outcomes:
measure: Bone Age Assessment using Ultrasound
timeFrame: 20 minutes
measure: Bone Age Assessment by imaging method using X-Ray
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Magglingen
country: Switzerland
facility: Swiss Federal Instistiution of Sport
Study officials:
affiliation: Responsible for R+D
name: Jon Wehrlin, Dr. scient.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Malina 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.
citation: Malina 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.
citation: Tanner, 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.