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

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

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.

Study Overview

• Status: Unknown
• Conditions: Bone Age Assessment
• Intervention / Treatment: Device: Ultrasound device; Radiation: XR

• Study Type: Interventional
• Enrollment (Anticipated): 416
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dennis Lüdin, MSc.; Phone Number: +41584663495; Email: dennis.luedin@baspo.admin.ch
• Study Contact Backup: Name: Michael Romann, Dr.; Email: michael.romann@baspo.admin.ch

Study Locations

• Switzerland
  • Magglingen, Switzerland
    • Swiss Federal Instistiution of Sport
    • Contact: Michael Romann, Dr.; Email: michael.romann@baspo.admin.ch
    • Contact: Dennis Lüdin, MSc; Phone Number: +58 4663495; Email: dennis.luedin@baspo.admin.ch
    • Principal Investigator: Dennis Lüdin, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 16 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Ultrasound; The intervention measurement is the determination of bone age using the ultrasound device.	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).
Other: XR; The control measurement is the determination of the bone age by the imaging method using X-rays.	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Swiss Federal Institute of Sport Magglingen
• Investigators: Principal Investigator: Jon Wehrlin, Dr. scient., Responsible for R+D

Publications and helpful links

General Publications

• 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. doi: 10.1080/02640410410001729928.
• 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.
• Malina RM, Coelho E Silva MJ, Figueiredo AJ, Carling C, Beunen GP. Interrelationships among invasive and non-invasive indicators of biological maturation in adolescent male soccer players. J Sports Sci. 2012;30(15):1705-17. doi: 10.1080/02640414.2011.639382. Epub 2012 Feb 3.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2020
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): July 1, 2021

Study Registration Dates

• First Submitted: March 5, 2020
• First Submitted That Met QC Criteria: March 9, 2020
• First Posted (Actual): March 10, 2020

Study Record Updates

• Last Update Posted (Actual): March 10, 2020
• Last Update Submitted That Met QC Criteria: March 9, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 2019-00526

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No