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临床试验/NCT04643912
NCT04643912已完成不适用

Bone Vibration as a Novel Screening Tool for Long Bone Fractures in Children

Sheffield Children's NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年10月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
Diagnostic accuracy of vibration analysis for detecting wrist and ankle fractures

研究概览

简要总结

When assessing an injured child, doctors must decide whether or not there is an underlying bone fracture. The best way of doing this is to take an x-ray.

In 2011, the 46,000 children attending Sheffield Children's Hospital Emergency Department had 10,400 x-rays mainly to help diagnose fractures. Taking just the foot and wrist, 2,215 x-rays were normal with no fracture, at a cost of £119,610 for the Sheffield community alone (at tariff £54 per x-ray). This works out as a cost of approximately £12 million per year across England and Wales. Additionally, although the radiation dose is quite small, given that x-rays can cause cancer, no radiation is better than some radiation.

A fracture screening method is needed that will help doctors, schoolteachers and others more reliably decide which children should have an x-ray.

Vibration is reliably used in industry to find defects such as cracks in machines and other structures. The researchers believe that vibration can similarly find fractures in bones in children. The team has recently demonstrated the ability of vibration to correctly pick the 3 x-ray confirmed cases out of 13 adults who had a wrist fracture (7 healthy adults and 6 with wrist injury). None of the 6 injured adults felt that vibration would be too painful to use on injured children.

The proposal is now to compare the vibration patterns of the bones of about 150 children over 10 years of age attending the researchers' Emergency Department with their fracture positive or fracture negative x-rays. The researchers also propose to assess any differences in the vibration patterns between left and right wrist and ankles in 50 healthy school children with no injury.

Should vibration analysis for fracture screening prove sufficiently accurate, further larger studies shall be conducted, with the aim of developing an instrument that will reduce the number of injured children having unnecessary x-rays. On completion of this study, the plan is to extend the study to include younger children.

This will lead to cost savings for the NHS and less inconvenience for patients and their families, with shorter stays in Emergency Departments and reduced population exposure to harmful ionising radiation.

详细描述

The main research question underpinning this pilot study is, "Can vibration spectra reliably distinguish fractured from non-fractured bones in children?"

The Problem:

A significant number of unnecessary radiographs are performed to exclude the presence of fractures. In 2011, 46,000 children attended Sheffield Children's Hospital Emergency Department (ED), for whom 10,400 radiographs were performed. 2,215 foot/ankle and wrist radiographs alone proved unnecessary. This translates to a potential cost saving of £119,610/year in Sheffield and approximately £12M/year in England and Wales.

Clearly there is the need for a non-invasive, portable, cheap and rapid method of screening long bones for fractures to establish the probability of whether the bone is fracture negative or positive; those with a high probability of fracture then going on to be radiographed, to establish presence, type and position of fracture.

A Possible Solution:

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
10 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Diagnostic accuracy of vibration analysis for detecting wrist and ankle fractures

时间窗: 4 years

Number of patients correctly stratified by vibration analysis into fracture and non-fracture groups (reference standard = wrist/ankle radiographs)

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 (2)

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