BASIC Study: Bone Age Study In Children (BASIC)

January 2, 2020 updated by: Sheffield Children's NHS Foundation Trust

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Sheffield (South Yorkshire District)
      • Sheffield, Sheffield (South Yorkshire District), United Kingdom, S10 2TH
        • Sheffield Children's NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 20 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Use of hand outline for bone age xray
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.
Device: Hand outline
A simple outline of a hand, to which the child tried to match their own hand on order to improve positioning.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
16 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheffield Children's NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

April 23, 2015

First Submitted That Met QC Criteria

January 2, 2020

First Posted (Actual)

January 3, 2020

Study Record Updates

Last Update Posted (Actual)

January 3, 2020

Last Update Submitted That Met QC Criteria

January 2, 2020

Last Verified

December 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • SCH/13/048

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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