BASIC Study: Bone Age Study In Children

Skeletal Age Maturation Clinical Trial

— BASIC  

Official title:

Bone Age Study In Children (BASIC): A Simple Intervention to Improve the Quality of Bone Age X-rays

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04216914
• Other study ID #: SCH/13/048
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: June 2015

Study information

• Verified date: December 2019
• Source: Sheffield Children's NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will see if the introduction of a hand outline on the Xray plate on which the child rests their hand will improve the quality of the Xray and reduce exposure to additional radiation by not having xrays repeated. The child will be asked to stretch their hand flat to match the outline, thus ensuring the correct position.

Description:

The study of left wrist/hand Xrays can help children's doctors to ascertain the age of a child's skeleton, know how much growing they still have to do and predict how tall they will be as an adult. The Xray requires the child to keep their hand flat and still and in the correct orientation. Some children, especially young ones, find this difficult and therefore the quality of the Xray can mean that aging the skeleton is difficult and may require the Xray to be taken again.

This study will see if the introduction of a hand outline on the Xray plate on which the child rests their hand will improve the quality of the Xray and reduce exposure to additional radiation by not having xrays repeated. The child will be asked to stretch their hand flat to match the outline, thus ensuring the correct position.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 20 Years

Eligibility

Inclusion Criteria:

• Children who are having a bone age Xray as part of their endocrinological hospital management.

Exclusion Criteria:

• Patients who do not give informed consent to be included in the study.

• As this study is very small and non externally funded, we will not be able to produce translations of the information sheets and consent/assent forms. This means that where patients are unable to fully give informed consent due to language barriers, they will be excluded from the study.

• )Any child with a left hand abnormality making them unable to place their hand flat e.g. contractures will be excluded.

• Any child too young or with significant enough learning difficulties making their compliance with the instructions too problematic. This will be at the discretion of the medical professional consenting the patient and the radiographer.

Related Conditions & MeSH terms

• Skeletal Age Maturation

Intervention

Device:
• Hand outline
A simple outline of a hand, to which the child tried to match their own hand on order to improve positioning.

Locations

Country	Name	City	State
United Kingdom	Sheffield Children's NHS Foundation Trust	Sheffield	Sheffield (South Yorkshire District)

Sponsors (1)

Lead Sponsor	Collaborator
Sheffield Children's NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in X-ray quality score with use of hand outline for TW3 x-rays	Will providing a radiolucent hand outline, to help children correctly position their hand whilst having a bone aging X-ray taken.	16 months