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Validation Sonic Bone's Ultrasound System for Bone Age Assessment

NCT04301570 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 416

Last updated 2020-03-10

No results posted yet for this study

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.

Conditions

  • Bone Age Assessment

Interventions

DEVICE

Ultrasound device

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).

RADIATION

XR

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

Sponsors & Collaborators

  • Swiss Federal Institute of Sport Magglingen

    lead OTHER_GOV

Principal Investigators

  • Jon Wehrlin, Dr. scient. · Responsible for R+D

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
10 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-05-31
Primary Completion
2020-12-31
Completion
2021-07-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04301570 on ClinicalTrials.gov