BASIC Study: Bone Age Study In Children

Not Applicable

Completed

• Conditions: Skeletal Age Maturation
• Interventions: Device: Hand outline

• Registration Number: NCT04216914
• Lead Sponsor: Sheffield Children's NHS Foundation Trust

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2015-04-23
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2019-12
• Study First Submitted QC: 2020-01-02
• Last Update Submitted: 2020-01-02
• Study First Posted: 2020-01-03
• Last Update Posted: 2020-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Use of hand outline for bone age xray	Hand outline	Where children and young people are having left hand X-rays for clinical purposes the radiographer will place a template under their hand. The plate is designed not to show up on the X-ray and to not interfere with the X-ray itself. They will be asked to match their hand to the hand outline on the template.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Sheffield Children's NHS Foundation Trust; 🇬🇧 Sheffield, Sheffield (South Yorkshire District), United Kingdom