Fractures, BoneNCT05536622
Hi-Res IR Thermography for the Diagnosis of Toddler's Fractures
A study testing High resolution infrared imaging in people with Fractures, Bone, run by Sheffield Children's NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This is a pilot proof of feasibility study to explore the efficacy of high resolution thermal imaging (HRTI) to screen for toddler's fractures. In HRTI, a sensitive thermal camera is used to capture the temperature profile of the suspected fracture region and then analyse and interpret the information using image… Read more about this study
- Who is it for?
- Ages 9 months to 5 years
- Conditions the study is for
- Fractures, Bone
- What is being tested?
- High resolution infrared imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Feb 2021to 30 Sep 2022
- 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 9 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 9 months-5 years (inclusive)
- Clinical suspicion of Toddler's fracture i.e x-rayed as part of their standard clinical management (confirmation of diagnosis).
- Injury within the preceding 72 hours.
- Ability to understand written and /or verbal consent and participant information.
Who cannot join
- Significant pain or discomfort (requiring second line analgesia as defined by ED guidelines)
- Multiple injuries (not localised to a single lower limb)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Clinical Research Facility, Sheffield Children's Hospital
Sheffield, S10 2TH
Paul Dimitri, paul.dimitri@nhs.net
About this study
Official title: High Resolution Infrared Thermal Imaging for the Diagnosis of Toddler's Fractures: A Pilot Diagnostic Study
This is a pilot proof of feasibility study to explore the efficacy of high resolution thermal imaging (HRTI) to screen for toddler's fractures. In HRTI, a sensitive thermal camera is used to capture the temperature profile of the suspected fracture region and then analyse and interpret the information using image processing.
Toddler's fractures are a common type of tibial fracture in children under 5 years old that can be particularly difficult to detect as the bone typically appears normal on x-ray for the first 10 days and becomes detectable thereafter only as new bone forms. The child's leg is put in plaster in the interim and the diagnosis cannot be confirmed until 10-14 days later. Around 60% of children with suspected toddler's fracture will not have a fracture, and would therefore have had plaster, repeat attendances and repeat x-ray unnecessarily. There is also the inconvenience and general risks of plaster immobilisation for the child. In an earlier study, the investigators demonstrated that HRTI has potential in diagnosing limp in children. This study included two children with toddler's fracture where HRTI detected the fracture's location on the patient's first Emergency Department(ED) visit. In this study, the investigators aim to build on earlier work to explore HRTI for screening for toddler's fracture. On its successful completion, the investigators aim to develop the technology in a follow on larger diagnostic study as a tool that could be used to quickly exclude cases where the injury has not resulted in a fracture. This would allow more objective decision making during the initial assessment of the child. In addition, a reduction in the number of unnecessary x-rays, revisits, treatment as well as cost is anticipated.
Read the detailed description
High resolution thermal imaging (HRTI) imaging is based on recording and processing of a part of electromagnetic spectrum below visible light i.e. infrared (IR) band. Objects with a temperature above -273 °C (-459.7 °F) emit IR (i.e. thermal) radiation. In HRTI a highly sensitive thermal camera that operates to the mid (3-5 μm) and long (7-14 μm) IR bands of the electromagnetic spectrum is used for imaging. The method results in a series of images (capture rate typically 30 frames per second). The images are processed using specialised software to extract and interpret its information. This includes neural networks and similar artificial intelligence models.
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 can be an indication of an injury. The use of infrared HRTI in paediatric for musculoskeletal diagnosis and monitoring as well as physiological measurements have showed potential. Examples of the related studies are:
- Vertebral fractures were detected in osteogenesis imperfecta patients using thermal imaging .
- Thermal imaging assisted in diagnosis of limp, including bone fracture cases
- Thermal imaging showed potential for differentiating between wrist fracture and sprain.
- Thermal imaging could accurately quantify the temperature difference between inflamed and uninflamed knees thus assisting with the diagnosis of juvenile idiopathic arthritis.
- Infrared thermal imaging has proved valuable in detecting inflammatory intra-abdominal pathology in infants.
- Thermal imaging provided effective for measuring respiration rate in a non- contact manner, i.e. no sensing unit attached to the patient's body.
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 thermoregulatory role, i.e. it generates, absorbs, conducts and radiates heat. Changes in the skin surface temperature are valuable in detecting physiological and pathological states such as inflammation.
With recent developments in thermal imaging devices, the use of infrared imaging for injury examination is expanding, with more evidence supporting its use. However, the data in children are still limited, with the investigators' research group undertaking significant development work in this field.
In this study the IR emission (characterised by heat radiation) from the skin at the site of injury is imaged and analysed to screen for a toddler's fracture. The hypothesis is that the inflammation and blood perfusion in fracture and less severe injuries at the site of injury are distinct, leading to distinct temperature gradients.
Toddler's fracture is characterised as a non-displaced spiral fracture of the tibial shaft in young children, usually between the ages of 9 months to 3 years. However other lower extremity injuries in young children can also have similar clinical appearance to the non-displaced spiral tibial fracture. Toddler's fracture usually results from an indirect innocuous twisting or rotational force applied to the foot and lower leg. The cause could be a stumble or fall or attempts to extricate the foot from between the bars of a crib for example.
Innovations in the use of HRTI in screening toddler's fracture can be beneficial as this could reduce the number of unnecessary x-ray radiographs by filtering out cases where the bone is not fractured. Given that toddler's fracture may not be visible on the radiograph close to the time of the injury's occurrence and a repeat radiograph around 10 days is usually required, earlier identification of a fracture would be beneficial. HRTI may be able to detect a fracture at the index visit, thus allowing directed management.
- Conditions
- Fractures, Bone
- Being tested
- High resolution infrared imaging
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High resolution infrared imagingDiagnostic test
High resolution infrared imaging of limb of concern and unaffected limb (control).
| Study group | Role | What they receive |
|---|---|---|
| Infrared imaging of affected tibia | Experimental | All eligible children will have infrared imaging undertaken of both affected limb and unaffected limb simultaneously. Receives: Diagnostic Test: High resolution infrared imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic probability thresholds for Infrared data (delta-temperature thresholds) for identifying Toddler fractures.
Diagnostic performance (Sensitivity, Specificity) at different thresholds of infrared data measures (measure = delta-temperature; unit = degrees Celsius - as assessed by trained neural networks using temperature data from the high resolution IR camera). Gold standard is clinical diagnosis compared with neural network diagnosis in children with a toddlers fracture.
Measured: 12 months
Secondary outcomes (2)
Effective recruitment strategy
Feasibility of recruitment strategy and conversion rates (% eligible), reasons for non-inclusion/opting out of study (% of eligible).
Attrition rates (%). To inform sample size calculation/feasibility of larger trial.
Measured: 12 months
Identification of relevant Parent related experience measures
Patient/parent qualitative interviews to determine parent experience of care pathway and relative importance to design of future trial. Unvalidated questionnaire used in interviews for exploratory purposes, as no validated tool exists for this area of care.
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 posted13 Sep 2022
- Study start11 Feb 2021
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheffield Children's NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shammi Ramlakhan, Study director, Sheffield Children's NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05536622
- Sponsor's protocol ID
- SCH-2528
- Status last verified
- Sep 2022
- First submitted
- 4 Jun 2021
- 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
- High Resolution Infrared Thermal Imaging for the Diagnosis of Toddler's Fractures: A Pilot Diagnostic Study
- ClinicalTrials.gov ID
- NCT05536622
- Acronym / sponsor ID
- SCH-2528
- Conditions
- Fractures, Bone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sheffield Children's NHS Foundation TrustUniversity, hospital or other
- Study start
- 11 Feb 2021 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 13 Sep 2022 (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.
This is a pilot proof of feasibility study to explore the efficacy of high resolution thermal imaging (HRTI) to screen for toddler's fractures. In HRTI, a sensitive thermal camera is used to capture the temperature profile of the suspected fracture region and then analyse and interpret the information using image processing.
Toddler's fractures are a common type of tibial fracture in children under 5 years old that can be particularly difficult to detect as the bone typically appears normal on x-ray for the first 10 days and becomes detectable thereafter only as new bone forms. The child's leg is put in plaster in the interim and the diagnosis cannot be confirmed until 10-14 days later. Around 60% of children with suspected toddler's fracture will not have a fracture, and would therefore have had plaster, repeat attendances and repeat x-ray unnecessarily. There is also the inconvenience and general risks of plaster immobilisation for the child. In an earlier study, the investigators demonstrated that HRTI has potential in diagnosing limp in children. This study included two children with toddler's fracture where HRTI detected the fracture's location on the patient's first Emergency Department(ED) visit. In this study, the investigators aim to build on earlier work to explore HRTI for screening for toddler's fracture. On its successful completion, the investigators aim to develop the technology in a follow on larger diagnostic study as a tool that could be used to quickly exclude cases where the injury has not resulted in a fracture. This would allow more objective decision making during the initial assessment of the child. In addition, a reduction in the number of unnecessary x-rays, revisits, treatment as well as cost is anticipated.
Detailed description
High resolution thermal imaging (HRTI) imaging is based on recording and processing of a part of electromagnetic spectrum below visible light i.e. infrared (IR) band. Objects with a temperature above -273 °C (-459.7 °F) emit IR (i.e. thermal) radiation. In HRTI a highly sensitive thermal camera that operates to the mid (3-5 μm) and long (7-14 μm) IR bands of the electromagnetic spectrum is used for imaging. The method results in a series of images (capture rate typically 30 frames per second). The images are processed using specialised software to extract and interpret its information. This includes neural networks and similar artificial intelligence models.
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 can be an indication of an injury. The use of infrared HRTI in paediatric for musculoskeletal diagnosis and monitoring as well as physiological measurements have showed potential. Examples of the related studies are:
- Vertebral fractures were detected in osteogenesis imperfecta patients using thermal imaging .
- Thermal imaging assisted in diagnosis of limp, including bone fracture cases
- Thermal imaging showed potential for differentiating between wrist fracture and sprain.
- Thermal imaging could accurately quantify the temperature difference between inflamed and uninflamed knees thus assisting with the diagnosis of juvenile idiopathic arthritis.
- Infrared thermal imaging has proved valuable in detecting inflammatory intra-abdominal pathology in infants.
- Thermal imaging provided effective for measuring respiration rate in a non- contact manner, i.e. no sensing unit attached to the patient's body.
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 thermoregulatory role, i.e. it generates, absorbs, conducts and radiates heat. Changes in the skin surface temperature are valuable in detecting physiological and pathological states such as inflammation.
With recent developments in thermal imaging devices, the use of infrared imaging for injury examination is expanding, with more evidence supporting its use. However, the data in children are still limited, with the investigators' research group undertaking significant development work in this field.
In this study the IR emission (characterised by heat radiation) from the skin at the site of injury is imaged and analysed to screen for a toddler's fracture. The hypothesis is that the inflammation and blood perfusion in fracture and less severe injuries at the site of injury are distinct, leading to distinct temperature gradients.
Toddler's fracture is characterised as a non-displaced spiral fracture of the tibial shaft in young children, usually between the ages of 9 months to 3 years. However other lower extremity injuries in young children can also have similar clinical appearance to the non-displaced spiral tibial fracture. Toddler's fracture usually results from an indirect innocuous twisting or rotational force applied to the foot and lower leg. The cause could be a stumble or fall or attempts to extricate the foot from between the bars of a crib for example.
Innovations in the use of HRTI in screening toddler's fracture can be beneficial as this could reduce the number of unnecessary x-ray radiographs by filtering out cases where the bone is not fractured. Given that toddler's fracture may not be visible on the radiograph close to the time of the injury's occurrence and a repeat radiograph around 10 days is usually required, earlier identification of a fracture would be beneficial. HRTI may be able to detect a fracture at the index visit, thus allowing directed management.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infrared imaging of affected tibia | Experimental | Diagnostic Test: High resolution infrared imagingAll eligible children will have infrared imaging undertaken of both affected limb and unaffected limb simultaneously. |
Who may qualify
- Ages
- 9 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 9 months-5 years (inclusive)
- Clinical suspicion of Toddler's fracture i.e x-rayed as part of their standard clinical management (confirmation of diagnosis).
- Injury within the preceding 72 hours.
- Ability to understand written and /or verbal consent and participant information.
Key exclusion criteria (2 listed)
- Significant pain or discomfort (requiring second line analgesia as defined by ED guidelines)
- Multiple injuries (not localised to a single lower limb)
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 |
|---|---|---|
| High resolution infrared imagingHigh resolution infrared imaging of limb of concern and unaffected limb (control). | Diagnostic test | Infrared imaging of affected tibia |
Primary outcome
Diagnostic probability thresholds for Infrared data (delta-temperature thresholds) for identifying Toddler fractures.
Time frame: 12 months
Diagnostic performance (Sensitivity, Specificity) at different thresholds of infrared data measures (measure = delta-temperature; unit = degrees Celsius - as assessed by trained neural networks using temperature data from the high resolution IR camera). Gold standard is clinical diagnosis compared with neural network diagnosis in children with a toddlers fracture.
2 secondary outcomes
Effective recruitment strategy
Time frame: 12 months
Identification of relevant Parent related experience measures
Time frame: 12 months
Results and safety
Results are not available in the source record.
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.
Shammi Ramlakhan study director
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 High resolution infrared imaging 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 4 inclusion and 2 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: status not confirmed, 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Keith Pugh (0114 3053478, keith.pugh1@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic probability thresholds for Infrared data (delta-temperature thresholds) for identifying Toddler fractures. (time frame: 12 months). 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.