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Vibration as a Method of Fracture Screening in Children

NCT04643912 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-09-13

No results posted yet for this study

Summary

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.

Conditions

  • Bone Fracture

Interventions

DIAGNOSTIC_TEST

Vibration Device

Device which causes the bone to vibrate and records the spectrum of that vibration

Sponsors & Collaborators

  • Sheffield Children's NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Amaka Offiah, BSc,MBBS,PhD · Sheffield Children's NHS Foundation Trust

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
10 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-10-07
Primary Completion
2017-05-28
Completion
2020-01-06

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04643912 on ClinicalTrials.gov