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Validation Sonic Bone's Ultrasound System for Bone Age Assessment

Validation Sonic Bone's Ultrasound System for Bone Age Assessment (BAUS)

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04301570
Acronym
BAUS
Enrollment
416
Registered
2020-03-10
Start date
2020-05-31
Completion date
2021-07-31
Last updated
2020-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Age Assessment

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.

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).

RADIATIONXR

The measurement of bone age is performed via imaging procedure via X-ray (Röntgengerät, Stadler SE 4600, Littau, CH) of the left hand.

Sponsors

Swiss Federal Institute of Sport Magglingen
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Bone Age Assessment using Ultrasound20 minutesThe bone age is determined by the use of the new medical device according to the instructions for use.
Bone Age Assessment by imaging method using X-Ray20 minutesThe 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).

Countries

Switzerland

Contacts

Primary ContactDennis Lüdin, MSc.
dennis.luedin@baspo.admin.ch+41584663495
Backup ContactMichael Romann, Dr.
michael.romann@baspo.admin.ch

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026