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Completed

NCT Number: NCT04216914

BASIC Study: Bone Age Study In Children

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.

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Key information

Age range

Up to 20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sheffield Children's NHS Foundation Trust

Sheffield, Sheffield (South Yorkshire District), S10 2TH, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hand outline

Device

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

Primary outcomes

  1. Change in X-ray quality score with use of hand outline for TW3 x-rays

    Time frame: 16 months

    Will providing a radiolucent hand outline, to help children correctly position their hand whilst having a bone aging X-ray taken.

Sponsors and collaborators

Lead sponsor

Sheffield Children's NHS Foundation Trust

Other

Registry information

Official study title

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

Acronym: BASIC

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 3, 2020
Registry last updated
Jan 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.