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临床试验/NCT04216914
NCT04216914已完成不适用

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

Sheffield Children's NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2014年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
56
试验地点
1
主要终点
Change in X-ray quality score with use of hand outline for TW3 x-rays

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
— 至 20 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

  • •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.

研究组 & 干预措施

Use of hand outline for bone age xray

Experimental

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.

干预措施: Hand outline (Device)

结局指标

主要结局

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

时间窗: 16 months

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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