Fractures, BoneNCT05892484
HiRes Infrared Imaging for Wrist Injuries in Children v2
A study testing Thermal Imaging and X-RAY in people with Fractures, Bone, 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 bony fracture. The current way of doing this is by x-ray. In 2011, 46,000 children attended Sheffield Children's Hospital Emergency Department and 10,400 x-rays were taken - predominately for diagnosis of fractures. Read more about this study
- Who is it for?
- Ages 5 to 16 years
- Conditions the study is for
- Fractures, Bone
- What is being tested?
- Thermal Imaging and X-RAY
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Mar 2019to 13 Nov 2019
- 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 5 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 5-16 years who are admitted to the Emergency Department of Sheffield Children's Hospital for a wrist injury, and who are x-rayed as part of their standard clinical management. Inclusion is subject to both the patient and carer having read (or being read to in very young children) the information sheets and both the patient and carer consenting to participate.
Who cannot join
- Children who have multiple injuries (e.g. those involved in serious car accident accidents).
- Children who are too distressed (by pain or otherwise).
- Parents/carers who have difficulty understanding the nature of the study (e.g. non-native English speakers, those with disabilities impairing their understanding of the study etc.) will be excluded.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Clinical Research Facility, Sheffield Children's Hospital
Sheffield, S10 2TH
About this study
Official title: High Resolution Infrared Thermography as a Diagnostic Aid in Paediatric Wrist Injuries Version 2
When assessing an injured child, doctors must decide whether or not there is an underlying bony fracture. The current way of doing this is by x-ray. In 2011, 46,000 children attended Sheffield Children's Hospital Emergency Department and 10,400 x-rays were taken - predominately for diagnosis of fractures. For foot and wrist, 2,215 x-rays were 'normal' with no fracture, at a cost of £119,610 (at a tariff of £54 per x-ray). Considering the cost and undesired effect of radiation exposure, a better way to discriminate those patients with fracture is needed. The non-invasive technique of thermal imaging holds promise as a putative technique.
The investigators have earlier demonstrated the potential of thermal imaging for vertebral fractures, diagnosing limp and measuring respiration rate. This study investigates thermal imaging to screen for wrist fractures. The objectives are: (i) accurately identify fracture location, (ii) exclude cases that are sprain and thus reduce the need for their x-ray. The confirmation of a fracture would still require a x-ray. As the study is in collaboration with Sheffield Children's Hospital, only children will be included, however the findings will also be applicable to adults. Thermal imaging is a completely safe and harmless operation, as the camera is non-contact and emits no radiation.
Any trauma, such as a wrist fracture, results in changes in blood flow that in turn affects the skin surface temperature of the skin overlying the injury. These changes affect the amount of emitted infrared radiation and will be recorded and explored to find a marker to differentiate fractures and sprains.
Read the detailed description
Thermal (IR) imaging is based on recording and processing of a part of electromagnetic spectrum below visible light, i.e. infrared band. Objects with a temperature above -273°C (- 459.67°F) emit thermal radiation. In thermography a camera that is sensitive to the mid (3-5 μm) and long (7-14 μm) infrared bands of the electromagnetic spectrum is used. The detection of an injury using thermal imaging relies on underlying physiology of temperature differentials.
Dermal temperature differentials usually do not exceed 0.25°C, while differentials in excess of 0.65°C are consistently related to pathology. Therefore observation of a significant temperature differential is an indication of injury. The use of Infrared for musculoskeletal medical diagnosis and monitoring has been reported in many studies in children and adults.
- Vertebral fractures were detected using thermal imaging • Thermal imaging assisted in diagnosis of the causes of limp including bone fracture.
Thermography has detected a direct correlation between an increase in skin temperature and the existence of anterior) knee pain after implantation of artificial knee joints. It is suggested that thermal imaging is potentially valuable for a rapid, inexpensive and non-invasive diagnosis of pain and inflammation. Infrared spectroscopic analysis has been reported to be is a powerful tool for establishing the material properties that contribute to bone strength and so it thus has been helpful in improving the understanding of the changes in fragile bone.
- The temperature of the bone during drilling could increase above 47oC. This can cause irreversible osteonecrosis. A study used infrared thermal imaging to determine spatial distribution of increase in bone temperature during drilling.
Blood convection warms the skin by transfer of heat from the core and this process plays the major role in determining skin temperature. Skin's has a thermoregulation role, i.e. it generates, absorbs, conducts and radiates heat. Changes in the skin surface temperature are valuable in detecting physiological and pathological state such as inflammation.
With recent developments in thermal imaging devices, the use of infrared imaging for injury examination is gaining a growing interest, with more evidence supporting its use. However, the data in children is limited, with the investigators' research group undertaking the majority of work in this field currently.
In this study the infrared emission (characterised by heat radiation) from skin at the site of injury is imaged and analysed to differentiate between wrist fracture and sprain. The hypothesis is that the inflammation and blood perfusion in sprain and bone fracture at the site of injury are different leading to distinct temperature gradients at the site.
- Conditions
- Fractures, Bone
- Being tested
- Thermal Imaging, X-RAY
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermal ImagingDevice
Thermal Imaging device used to evaluate fracture in those presenting with proposed wrist fracture in the emergency department.
X-RAYDiagnostic test
Routine X-RAY
| Study group | Role | What they receive |
|---|---|---|
| Thermal Imaging | Experimental | Participants will receive thermal imaging in addition to their routine x-ray for comparison. Receives: Device: Thermal Imaging |
| X-ray | Other | Routine x-ray is what the active comparator is being evaluated against. Receives: Diagnostic Test: X-RAY |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Accuracy of Thermal Imaging to Detect Fractures
Percentage of fractures correctly identified by Thermal Imaging.
Measured: 12 months
Diagnostic accuracy of Thermal Imaging
Sensitivity and Specificity of thermal imaging in identifying or excluding fractures
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start13 Mar 2019
- Primary completion31 Aug 2019
- Study completion13 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fractures, BoneStudies 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
- Non-randomised
- Intervention model
- Single group
- Model description
- Comparison between thermal imaging and x-ray.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Children's NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shammi Ramlakhan, Principal investigator, Sheffield Children's NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05892484
- Sponsor's protocol ID
- SCH-2323
- Status last verified
- Jun 2023
- First submitted
- 4 Jun 2021
- Last updated
- 7 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Resolution Infrared Thermography as a Diagnostic Aid in Paediatric Wrist Injuries Version 2
- ClinicalTrials.gov ID
- NCT05892484
- Acronym / sponsor ID
- SCH-2323
- Conditions
- Fractures, Bone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Sheffield Children's NHS Foundation TrustUniversity, hospital or other
- Study start
- 13 Mar 2019 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 13 Nov 2019 (actual)
- First posted
- 7 Jun 2023 (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 bony fracture. The current way of doing this is by x-ray. In 2011, 46,000 children attended Sheffield Children's Hospital Emergency Department and 10,400 x-rays were taken - predominately for diagnosis of fractures. For foot and wrist, 2,215 x-rays were 'normal' with no fracture, at a cost of £119,610 (at a tariff of £54 per x-ray). Considering the cost and undesired effect of radiation exposure, a better way to discriminate those patients with fracture is needed. The non-invasive technique of thermal imaging holds promise as a putative technique.
The investigators have earlier demonstrated the potential of thermal imaging for vertebral fractures, diagnosing limp and measuring respiration rate. This study investigates thermal imaging to screen for wrist fractures. The objectives are: (i) accurately identify fracture location, (ii) exclude cases that are sprain and thus reduce the need for their x-ray. The confirmation of a fracture would still require a x-ray. As the study is in collaboration with Sheffield Children's Hospital, only children will be included, however the findings will also be applicable to adults. Thermal imaging is a completely safe and harmless operation, as the camera is non-contact and emits no radiation.
Any trauma, such as a wrist fracture, results in changes in blood flow that in turn affects the skin surface temperature of the skin overlying the injury. These changes affect the amount of emitted infrared radiation and will be recorded and explored to find a marker to differentiate fractures and sprains.
Detailed description
Thermal (IR) imaging is based on recording and processing of a part of electromagnetic spectrum below visible light, i.e. infrared band. Objects with a temperature above -273°C (- 459.67°F) emit thermal radiation. In thermography a camera that is sensitive to the mid (3-5 μm) and long (7-14 μm) infrared bands of the electromagnetic spectrum is used. The detection of an injury using thermal imaging relies on underlying physiology of temperature differentials.
Dermal temperature differentials usually do not exceed 0.25°C, while differentials in excess of 0.65°C are consistently related to pathology. Therefore observation of a significant temperature differential is an indication of injury. The use of Infrared for musculoskeletal medical diagnosis and monitoring has been reported in many studies in children and adults.
- Vertebral fractures were detected using thermal imaging • Thermal imaging assisted in diagnosis of the causes of limp including bone fracture.
Thermography has detected a direct correlation between an increase in skin temperature and the existence of anterior) knee pain after implantation of artificial knee joints. It is suggested that thermal imaging is potentially valuable for a rapid, inexpensive and non-invasive diagnosis of pain and inflammation. Infrared spectroscopic analysis has been reported to be is a powerful tool for establishing the material properties that contribute to bone strength and so it thus has been helpful in improving the understanding of the changes in fragile bone.
- The temperature of the bone during drilling could increase above 47oC. This can cause irreversible osteonecrosis. A study used infrared thermal imaging to determine spatial distribution of increase in bone temperature during drilling.
Blood convection warms the skin by transfer of heat from the core and this process plays the major role in determining skin temperature. Skin's has a thermoregulation role, i.e. it generates, absorbs, conducts and radiates heat. Changes in the skin surface temperature are valuable in detecting physiological and pathological state such as inflammation.
With recent developments in thermal imaging devices, the use of infrared imaging for injury examination is gaining a growing interest, with more evidence supporting its use. However, the data in children is limited, with the investigators' research group undertaking the majority of work in this field currently.
In this study the infrared emission (characterised by heat radiation) from skin at the site of injury is imaged and analysed to differentiate between wrist fracture and sprain. The hypothesis is that the inflammation and blood perfusion in sprain and bone fracture at the site of injury are different leading to distinct temperature gradients at the site.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Comparison between thermal imaging and x-ray.
| Arm | Type | Receives |
|---|---|---|
| Thermal Imaging | Experimental | Device: Thermal ImagingParticipants will receive thermal imaging in addition to their routine x-ray for comparison. |
| X-ray | Other | Diagnostic Test: X-RAYRoutine x-ray is what the active comparator is being evaluated against. |
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children aged 5-16 years who are admitted to the Emergency Department of Sheffield Children's Hospital for a wrist injury, and who are x-rayed as part of their standard clinical management. Inclusion is subject to both the patient and carer having read (or being read to in very young children) the information sheets and both the patient and carer consenting to participate.
Key exclusion criteria (3 listed)
- Children who have multiple injuries (e.g. those involved in serious car accident accidents).
- Children who are too distressed (by pain or otherwise).
- Parents/carers who have difficulty understanding the nature of the study (e.g. non-native English speakers, those with disabilities impairing their understanding of the study etc.) will be excluded.
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 |
|---|---|---|
| Thermal ImagingThermal Imaging device used to evaluate fracture in those presenting with proposed wrist fracture in the emergency department. | Device | Thermal Imaging |
| X-RAYRoutine X-RAY | Diagnostic test | X-ray |
Primary outcome
The Accuracy of Thermal Imaging to Detect Fractures
Time frame: 12 months
Percentage of fractures correctly identified by Thermal Imaging.
Diagnostic accuracy of Thermal Imaging
Time frame: 12 months
Sensitivity and Specificity of thermal imaging in identifying or excluding fractures
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 7 Jun 2023.
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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.
Shammi Ramlakhan principal investigator
Sheffield Children's NHS 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 Thermal Imaging and X-RAY in people with Fractures, Bone, 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 1 inclusion and 3 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 7 Jun 2023. 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?
The Accuracy of Thermal Imaging to Detect Fractures (time frame: 12 months). The study lists 2 primary outcomes in all. 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 7 Jun 2023.