Validation Sonic Bone's Ultrasound System for Bone Age Assessment

Not Applicable

• Conditions: Bone Age Assessment
• Interventions: Device: Ultrasound device; Radiation: XR

• Registration Number: NCT04301570
• Lead Sponsor: Swiss Federal Institute of Sport Magglingen

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-03
• Study First Submitted: 2020-03-05
• Study First Submitted QC: 2020-03-09
• Last Update Submitted: 2020-03-09
• Study First Posted: 2020-03-10
• Last Update Posted: 2020-03-10
• Study Start: 2020-05
• Primary Completion: 2020-12
• Study Completion: 2021-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 416

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ultrasound	Ultrasound device	The intervention measurement is the determination of bone age using the ultrasound device.
XR	XR	The control measurement is the determination of the bone age by the imaging method using X-rays.

Primary Outcome Measures

Name	Time	Method
Bone Age Assessment by imaging method using X-Ray	20 minutes	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).
Bone Age Assessment using Ultrasound	20 minutes	The bone age is determined by the use of the new medical device according to the instructions for use.

Trial Locations

Locations (1)

Swiss Federal Instistiution of Sport; 🇨🇭 Magglingen, Switzerland