Bone Age AssessmentBAUSNCT04301570
Validation Sonic Bone's Ultrasound System for Bone Age Assessment
A study testing Ultrasound device and XR in people with Bone Age Assessment, run by Swiss Federal Institute of Sport Magglingen at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Age Assessment
- What is being tested?
- Ultrasound device and XR
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 416 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2020to Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age between 10-18
- healthy
- voluntary participation
- consent of the participant or legal representative to participate in the project
- active in a sports club
Who cannot join
- pregnancy
Trial locations and contacts
1 site in 1 country.
Michael Romann, Dr. contact
Switzerland1 site
Swiss Federal Instistiution of Sport
Magglingen
Dennis Lüdin, MSc, +58 4663495, dennis.luedin@baspo.admin.ch
Michael Romann, Dr., michael.romann@baspo.admin.ch
About this study
Official title: 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.
- Conditions
- Bone Age Assessment
- Being tested
- Ultrasound device, XR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound deviceDevice
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).
XRRadiation
The measurement of bone age is performed via imaging procedure via X-ray (Röntgengerät, Stadler SE 4600, Littau, CH) of the left hand.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound | Other | The intervention measurement is the determination of bone age using the ultrasound device. Receives: Device: Ultrasound device |
| XR | Other | The control measurement is the determination of the bone age by the imaging method using X-rays. Receives: Radiation: XR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Age Assessment using Ultrasound
The bone age is determined by the use of the new medical device according to the instructions for use.
Measured: 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).
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study startMay 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Bone Age AssessmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 416 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Sport Magglingen
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Jon Wehrlin, Dr. scient., Principal investigator, Responsible for R+D
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04301570
- Sponsor's protocol ID
- 2019-00526
- Other IDs
- 2019
- Acronym
- BAUS
- Status last verified
- Mar 2020
- First submitted
- 5 Mar 2020
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 16194999Malina 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.
PubMed 26084525Malina 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.
PubMed 22304621Tanner, 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 at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation Sonic Bone's Ultrasound System for Bone Age Assessment (BAUS)
- ClinicalTrials.gov ID
- NCT04301570
- Acronym / sponsor ID
- BAUS / 2019-00526
- Conditions
- Bone Age Assessment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 416 participants (estimated)
- Lead sponsor
- Swiss Federal Institute of Sport MagglingenOther government
- Study start
- May 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 10 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound | Other | Device: Ultrasound deviceThe intervention measurement is the determination of bone age using the ultrasound device. |
| XR | Other | Radiation: XRThe control measurement is the determination of the bone age by the imaging method using X-rays. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age between 10-18
- healthy
- voluntary participation
- consent of the participant or legal representative to participate in the project
- active in a sports club
Key exclusion criteria (1 listed)
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound deviceThe 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). | Device | Ultrasound |
| XRThe measurement of bone age is performed via imaging procedure via X-ray (Röntgengerät, Stadler SE 4600, Littau, CH) of the left hand. | Radiation | XR |
Primary outcome
Bone Age Assessment using Ultrasound
Time frame: 20 minutes
The 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-Ray
Time frame: 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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- Background: PubMed 16194999Malina 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.
- Background: PubMed 26084525Malina 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.
- Background: PubMed 22304621Malina 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.
- BackgroundTanner, 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.
- Individual participant dataSharing planned: No
Related trials for Bone Age Assessment
Active, not recruitingPhase 2
A Clinical Trial to Evaluate Efficacy and Safety of Navepegritide in Adolescents (12 - 18 Years of Age) With Achondroplasia.
Achondroplasia
Active, not recruitingPhase 3
Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis Naive to Biologic Disease-Modifying Antirheumatic Drug
Arthritis, Psoriatic
Active, not recruitingPhase 3
Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis and Anti-TNFα Inadequate Response
Arthritis, Psoriatic
Not yet recruitingPhase 2
Study of TST002 Injection in Postmenopausal Women With Osteoporosis or Low Bone Mass
Postmenopausal Osteoporosis, Low Bone Mass
RecruitingPhase 3
Study to Assess the Pharmacokinetics, Safety, and Tolerability of Iptacopan in Pediatric PNH Patients
Paroxysmal Nocturnal Hemoglobinuria (PNH)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Romann, Dr. contact
Jon Wehrlin, Dr. scient. principal investigator
Responsible for R+D
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound device and XR in people with Bone Age Assessment, run by Swiss Federal Institute of Sport Magglingen at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dennis Lüdin, MSc. (+41584663495, dennis.luedin@baspo.admin.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone Age Assessment using Ultrasound (time frame: 20 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04301570, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2020.