Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04643912 |
| Other study ID # |
SCH/13/053b |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 7, 2016 |
| Est. completion date |
January 6, 2020 |
Study information
| Verified date |
September 2022 |
| Source |
Sheffield Children's NHS Foundation Trust |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
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:
Vibration analysis involves the mechanical excitation of an object, then recording and
analysing the subsequent responses . When a structure is allowed to move freely after an
excitation, it will vibrate at its specific natural frequencies where the inertial forces are
in balance with the elastic forces, depending upon the stiffness of that structure.
Vibration spectral analysis is reliably used in industry to detect cracks in machinery.
The researchers tested the hypothesis that fractured and non-fractured bones return different
vibration spectra on 13 adults; 7 healthy volunteers from the Engineering Department of
Sheffield Hallam University and 6 patients following injury at Northern General Hospital, 3
of whom had fractures , with 100% correlation of vibration spectra with presence/absence of
fracture and no pain.
Given these encouraging results, the proposal is to extend the study to children.
Research Theory:
The researchers postulate that there are detectable differences in the natural vibration
frequencies obtained from bones with and without fracture. Each child's uninjured
contralateral bone will serve as a comparison for the injured side.
The application of vibration analysis involves mechanical excitation of an object and
recording and analysing the subsequent responses. In theory, by applying a stimulus to the
bone and analysing the resulting response, it is possible to monitor various pathological and
trauma-induced conditions.
Vibrations may be induced either by an impulse, which yields a response consistent with the
inputting of a number of independent fundamental frequencies, or by variable frequency cycles
of pure sine waves.
Having induced the vibrations by a small purpose-built computer-controlled tapper, the
commonest method of recording them uses piezoelectric gauges on bony prominences (minimising
the effect of underlying soft tissue). For example, when analysing tibial fracture healing,
the lateral or medial malleolus are prime sites . Successful operation of piezoelectric
gauges depends on the coupling of the gauge to the structure under investigation, such that
the induced stresses produce a net change in charge of the transducer terminals due to the
piezoelectric effect.
Piezoelectric crystals are relatively inexpensive and their properties well understood. Both
piezoresistive and piezoelectric materials are commonly used to detect strain caused by
vibrations in macro-scale structures. However, they often require challenging signal
processing and interpretation. The research group has experience working with complex medical
signals (e.g. electroencephalograms) to extract relevant information and will bring this
experience to bear in this project.
Previous feasibility studies provide a sound basis for the proposed study. There is extensive
information on theory, techniques for vibration analysis of physical structures are well
established and furthermore, a number of studies have explored low-frequency vibration
analysis as a possible diagnostic tool in the orthopaedic field. For example, in one study it
was reported that the vibration transmission across a fracture is affected by the stages of
healing of the fracture callus.
As far as the researchers are aware, no study has used the precise methodology proposed in
this current study to screen for fractures in children.
