Bone FractureNCT04643912
Vibration as a Method of Fracture Screening in Children
A study testing Vibration Device in people with Bone Fracture, run by Sheffield Children's NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 10 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Fracture
- What is being tested?
- Vibration Device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Oct 2016to 6 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
None listed.
Who cannot join
- Age 9 years and 364 days or less. Age 16 years or more
- Injury sustained more than 24 hours before attendance
- Informed consent withheld
- Distressed child or family (most children will receive pain relief in the Emergency Department prior to having their radiographs and vibration analysis)
- Both arms or both legs thought to be fractured (the non-fractured contralateral limb will act as control for each child)
- Inability to access bony prominence
Show all 16Show fewer
- Presence of metal work (e.g. internal or external fixators), plaster of Paris or other cast
- Previously recorded fracture or orthopaedic surgery (this might affect vibration spectra).
- Healthy Controls We have previously obtained a letter of support from the Deputy Head of King Edward's VII Language College, Sheffield, to recruit 20 healthy children and perform vibration analysis at a convenient time (11.00am to 1.00pm on Saturdays). We have so far recruited 15 healthy children and will seek permission from the Head/Deputy Head to extend the original 20 to 50.
- Age 9 years and 364 days or less. Age 16 years or more
- Previous fracture to any wrist or ankle
- Previous surgery to any wrist or ankle
- Known chronic disease (any long-term disease on-going for over one year)
- Informed consent withheld
- Inability to access bony prominence
- Presence of metal work (e.g. internal or external fixators), plaster of Paris or other cast, limb prosthesis
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Children's NHS Foundation Trust
Sheffield, Sheffield (South Yorkshire District), S10 2TH
About this study
Official title: Bone Vibration as a Novel Screening Tool for Long Bone Fractures in Children
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.
Read more
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.
Read the detailed 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.
- Conditions
- Bone Fracture
- Being tested
- Vibration Device
- Keywords
- Medical device, Vibration
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibration DeviceDiagnostic test
Device which causes the bone to vibrate and records the spectrum of that vibration
| Study group | Role | What they receive |
|---|---|---|
| Injured wrist or ankle | Experimental | Child with trauma needing wrist or ankle x-ray:
Will receive vibration analysis blinded to x-ray findings. Receives: Diagnostic Test: Vibration Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of vibration analysis for detecting wrist and ankle fractures
Number of patients correctly stratified by vibration analysis into fracture and non-fracture groups (reference standard = wrist/ankle radiographs)
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start7 Oct 2016
- Primary completion28 May 2017
- Study completion6 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Measuring the effectiveness of vibration fracture analysis against standard radiographs.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Children's NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amaka Offiah, BSc,MBBS,PhD, Principal investigator, Sheffield Children's NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04643912
- Sponsor's protocol ID
- SCH/13/053b
- Status last verified
- Sep 2022
- First submitted
- 3 Nov 2020
- Last updated
- 13 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Vibration as a Novel Screening Tool for Long Bone Fractures in Children
- ClinicalTrials.gov ID
- NCT04643912
- Acronym / sponsor ID
- SCH/13/053b
- Conditions
- Bone Fracture
- Keywords
- Medical device, Vibration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sheffield Children's NHS Foundation TrustUniversity, hospital or other
- Study start
- 7 Oct 2016 (actual)
- Primary completion
- 28 May 2017 (actual)
- Study completion
- 6 Jan 2020 (actual)
- First posted
- 25 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Measuring the effectiveness of vibration fracture analysis against standard radiographs.
| Arm | Type | Receives |
|---|---|---|
| Injured wrist or ankle | Experimental | Diagnostic Test: Vibration DeviceChild with trauma needing wrist or ankle x-ray: Will receive vibration analysis blinded to x-ray findings. |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (16 listed)
- Age 9 years and 364 days or less. Age 16 years or more
- Injury sustained more than 24 hours before attendance
- Informed consent withheld
- Distressed child or family (most children will receive pain relief in the Emergency Department prior to having their radiographs and vibration analysis)
- Both arms or both legs thought to be fractured (the non-fractured contralateral limb will act as control for each child)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vibration DeviceDevice which causes the bone to vibrate and records the spectrum of that vibration | Diagnostic test | Injured wrist or ankle |
Primary outcome
Diagnostic accuracy of vibration analysis for detecting wrist and ankle fractures
Time frame: 4 years
Number of patients correctly stratified by vibration analysis into fracture and non-fracture groups (reference standard = wrist/ankle radiographs)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amaka Offiah, BSc,MBBS,PhD principal investigator
Sheffield Children's NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibration Device in people with Bone Fracture, run by Sheffield Children's NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of vibration analysis for detecting wrist and ankle fractures (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2022.