Validation Sonic Bone's Ultrasound System for Bone Age Assessment

Study Overview
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Brief Summary
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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.

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

Conditions
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Bone Age Assessment

Intervention / Treatment
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* Device: Ultrasound device
* Radiation: XR


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Ultrasound<br>The intervention measurement is the determination of bone age using the ultrasound device. | Device: Ultrasound device<br>* 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).<br>|
| Other: XR<br>The control measurement is the determination of the bone age by the imaging method using X-rays. | Radiation: XR<br>* The measurement of bone age is performed via imaging procedure via X-ray (Röntgengerät, Stadler SE 4600, Littau, CH) of the left hand.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |