Bone Age Assessment Clinical Trial
— BAUSOfficial title:
Validation Sonic Bone's Ultrasound System for Bone Age Assessment (BAUS)
| NCT number | NCT04301570 |
| Other study ID # | 2019-00526 |
| Secondary ID | |
| Status | Not yet recruiting |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | May 2020 |
| Est. completion date | July 2021 |
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.
| Status | Not yet recruiting |
| Enrollment | 416 |
| Est. completion date | July 2021 |
| Est. primary completion date | December 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 10 Years to 18 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | Swiss Federal Instistiution of Sport | Magglingen |
| Lead Sponsor | Collaborator |
|---|---|
| Swiss Federal Institute of Sport Magglingen |
Switzerland,
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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. — View 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. Review. — View 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.
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 |