Musculoskeletal InfectionNCT07388017
Infrared Thermography for Diagnosis of Musculoskeletal Infections
An observational study of Musculoskeletal Infection and Septic Arthritis, 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 Infrared Thermographic Imaging (HRTI) to assist with the detection of musculoskeletal infections in children. Read more about this study
- Who is it for?
- Ages 0 to 15 years
- Conditions the study is for
- Musculoskeletal Infection, Septic Arthritis, Osteomyelitis/Septic Arthritis
- What is being tested?
- High Resolution Thermal Imaging
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Feb 2025to 31 Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 0 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Paediatric patients ages 0-15 presenting to Sheffield Children's Hospital with a suspected primary muscoloskeltal infection
Who may be able to join
- Children and young people from neonates to 15 years of age:
- With clinical suspicion of a primary MSK infection (irrespective of location or aetiology), as defined by presenting symptoms, physical examination and bloodwork performed by a qualified clinician.
- Presenting to Sheffield Children's Hospital via A\&E or referral from another hospital.
- Who are able to interpret the information given in the information sheet/assent form on paper in English (with the exception of children under the age of 3 years who are not required to assent.)
- With at least 1 competent legal guardian who is capable of legally consenting, and interpreting the information given in the information sheet in English.
- Where a medical doctor involved in their care has agreed that their participation in the study will not negatively impact on their treatment outcome
Who cannot join
- - Have a secondary MSK infection.
- Are severely ill or need urgent/critical attention or have comorbid conditions that will complicate their care, as decided by a medical doctor involved in their treatment.
- Patients with conditions including but not limited to leukaemia, hyper/hypothyroidism, diabetes mellitus or any other condition that affects their basal metabolic rate/body temperature.
- Amputees where the amputated region is contralateral to the region of suspected infection.
- Have received an a priori diagnosis or have already undergone any investigation. This includes patients admitted for a recurrence/exacerbation of recently diagnosed MSK infection.
- Any patient where the medical team responsible for their treatment raises concerns that HRTI could negatively impact their treatment outcome.
- The patient, or their legal guardian(s) do not consent or assent/withdraw consent or assent/ or are not able to consent or assent for any reason. (Eg. The patient/guardian(s) are non-English speakers or have disabilities impairing their understanding of the study.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Sheffield Children's NHS Foundatin Trust
Sheffield, South Yorkshire, S10 2TH
Research and Development Manager, +44 0114 271 7000, scn-tr.research.governance@nhs.net
Sanjeev Madan
About this study
Official title: High Resolution Thermographic Imaging as a Diagnostic Aid in Paediatric Infections of Bones, Joints, and Soft Tissues
This is a pilot proof of feasibility study to explore the efficacy of High Resolution Infrared Thermographic Imaging (HRTI) to assist with the detection of musculoskeletal infections in children. In HRTI, a sensitive thermal camera is used to capture the temperature profile of the suspected infected body region in the form of images. In this study, a 10-second video will be recorded to allow dynamic monitoring. The resulting video will be processed and interpreted to determine whether there is a musculoskeletal infection.
Bone, joint and soft tissue infections can be caused by bacteria which can enter the body through accidental injuries, or because of surgery or implants. Once in the body, they circulate through the bloodstream until they reach a bone, joint, or muscle, multiply and cause infection. These conditions can cause significant complications in children and adults and can even result in death if untreated.
Read more
Infections of the bone, called osteomyelitis can inhibit bone growth in children. As a result, children who have suffered from osteomyelitis may require extensive treatment later in childhood. While osteomyelitis accounts for only 1% of childhood hospital admissions, its incidence in children has increased in recent decades. This is associated with an increase in the prevalence of antibiotic resistant bacteria such as MRSA.
Infections of the joint, called septic arthritis, is an emergency condition that requires prompt diagnosis and treatment. Long delays in diagnosis and surgical drainage of the joint may lead to irreversible damage to the cartilage and bone destruction.
There is currently a need for improved technologies to screen for and monitor bone, joint, and soft tissue infections. Plain radiographs appear normal in the first 7 to 10 days of osteomyelitis. Magnetic resonance imaging (MRI) is the most sensitive modality for diagnosing osteomyelitis. However, MRI scans are costly their accessibility is limited, plus the scan can take 30 minutes to perform. As the child needs to be still during the scan, sedation is required.
Infrared thermal imaging is a harmless, cost effective and rapid scanning method that has proven industrial applications such as condition monitoring of machineries and fault findings. There has also been extensive interest in utilising and this technology for medical diagnosis and monitoring. This study builds on our earlier work that used HRTI to detect inflammation in the abdomen in infants. This technology may allow timelier and more cost-effective diagnosis of the condition. Sheffield Children's Hospital and Sheffield Hallam University collaborate in conducting the study.
The study will involve recruiting 30 patients at Sheffield Children's Hospital with suspected infection of either bone, joint or soft tissue. They will have their HRTI recorded and processed to follow up the study's research questions. The findings from the study will not alter the routine medical treatments of the patients and participation is voluntary.
- Being tested
- High Resolution Thermal Imaging
- Medical subject headings
- Arthritis, Infectious, Osteomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Resolution Thermal ImagingDevice
A HRTI camera is a non-invasive medical device that will be utilised on patients that present in ED with an MSK infection. The goal of this intervention is to answer the following:
Can combined HRTI and blood tests provide a higher diagnostic reliability than HRTI on its own? Can combined HRTI and artificial intelligence (AI) provide a timelier (as compared to existing modalities) detection of bone, joint and soft tissue infection thus allowing a more effective treatment? What are patients views and feedback for the new HRTI method?
| Study group | Role | What they receive |
|---|---|---|
| Septic Arthritis | Patients are stratified into two arms. If the participant is admitted with septic arthritis they will be prepared to be taken to theatres to have routine surgery. After the patients is in the theatre under general anaesthesia and immediately prior to surgery the research team will perform the study intervention. This is using a High Resolution Thermal Imaging camera to take an image of the infected area. Receives: Device: High Resolution Thermal Imaging | |
| Non-Emergent Musculoskeletal Infection | Patients are stratified into two arms. If the participant is admitted with a non emergent MSK infection, the patient will be prepared to have an MRI scan. Immediately prior to the MRI scan, the research team will perform the study intervention. This is using a High Resolution Thermal Imaging camera to take an image of the infected area. Receives: Device: High Resolution Thermal Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thermal profile variability in affected and contralateral region of interest.
On admission (Day 1), thermal images of the affected and contralateral limbs are obtained. This generates a thermal profile through which the temperature (°C) can be extracted. A region of interest is drawn around the suspected anatomical zone of the infection. This outcome measure will compare differences in the temperature (°C) of the affected and contralateral region of interest. This will include the mean temperature difference and the hottest and coldest spots in each zone, respectively.
Measured: Admission to hospital (Day 1)
Secondary outcomes (3)
Erythrocyte Sedimentation rate (ESR)
On admission (DAY 1) blood will be drawn and ESR will be recorded in millimeters per hour (mm/hr)
Measured: On admission (day 1)
C-reactive protein (CRP)
On admission (DAY 1), blood will be drawn and CRP will be measured in milligrams per litre (mg/L).
Measured: On admission (Day 1)
White blood cell count (WBC)
On admission (DAY 1), bloods will be drawn and the white blood cell count (x10^9/L) will be recorded.
Measured: On admission (day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start17 Feb 2025
- Primary completion31 Jan 2026 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal InfectionStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheffield Children's NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07388017
- Sponsor's protocol ID
- SCH-2913
- Status last verified
- Mar 2025
- First submitted
- 18 Feb 2025
- Last updated
- 4 Feb 2026
- 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 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Resolution Thermographic Imaging as a Diagnostic Aid in Paediatric Infections of Bones, Joints, and Soft Tissues
- ClinicalTrials.gov ID
- NCT07388017
- Acronym / sponsor ID
- SCH-2913
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sheffield Children's NHS Foundation TrustUniversity, hospital or other
- Study start
- 17 Feb 2025 (actual)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 4 Feb 2026 (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 Infrared Thermographic Imaging (HRTI) to assist with the detection of musculoskeletal infections in children. In HRTI, a sensitive thermal camera is used to capture the temperature profile of the suspected infected body region in the form of images. In this study, a 10-second video will be recorded to allow dynamic monitoring. The resulting video will be processed and interpreted to determine whether there is a musculoskeletal infection.
Bone, joint and soft tissue infections can be caused by bacteria which can enter the body through accidental injuries, or because of surgery or implants. Once in the body, they circulate through the bloodstream until they reach a bone, joint, or muscle, multiply and cause infection. These conditions can cause significant complications in children and adults and can even result in death if untreated.
Infections of the bone, called osteomyelitis can inhibit bone growth in children. As a result, children who have suffered from osteomyelitis may require extensive treatment later in childhood. While osteomyelitis accounts for only 1% of childhood hospital admissions, its incidence in children has increased in recent decades. This is associated with an increase in the prevalence of antibiotic resistant bacteria such as MRSA.
Infections of the joint, called septic arthritis, is an emergency condition that requires prompt diagnosis and treatment. Long delays in diagnosis and surgical drainage of the joint may lead to irreversible damage to the cartilage and bone destruction.
There is currently a need for improved technologies to screen for and monitor bone, joint, and soft tissue infections. Plain radiographs appear normal in the first 7 to 10 days of osteomyelitis. Magnetic resonance imaging (MRI) is the most sensitive modality for diagnosing osteomyelitis. However, MRI scans are costly their accessibility is limited, plus the scan can take 30 minutes to perform. As the child needs to be still during the scan, sedation is required.
Infrared thermal imaging is a harmless, cost effective and rapid scanning method that has proven industrial applications such as condition monitoring of machineries and fault findings. There has also been extensive interest in utilising and this technology for medical diagnosis and monitoring. This study builds on our earlier work that used HRTI to detect inflammation in the abdomen in infants. This technology may allow timelier and more cost-effective diagnosis of the condition. Sheffield Children's Hospital and Sheffield Hallam University collaborate in conducting the study.
The study will involve recruiting 30 patients at Sheffield Children's Hospital with suspected infection of either bone, joint or soft tissue. They will have their HRTI recorded and processed to follow up the study's research questions. The findings from the study will not alter the routine medical treatments of the patients and participation is voluntary.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Septic Arthritis | – | Device: High Resolution Thermal ImagingPatients are stratified into two arms. If the participant is admitted with septic arthritis they will be prepared to be taken to theatres to have routine surgery. After the patients is in the theatre under general anaesthesia and immediately prior to surgery the research team will perform the study intervention. This is using a High Resolution Thermal Imaging camera to take an image of the infected area. |
| Non-Emergent Musculoskeletal Infection | – | Device: High Resolution Thermal ImagingPatients are stratified into two arms. If the participant is admitted with a non emergent MSK infection, the patient will be prepared to have an MRI scan. Immediately prior to the MRI scan, the research team will perform the study intervention. This is using a High Resolution Thermal Imaging camera to take an image of the infected area. |
Who may qualify
- Ages
- 0 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Paediatric patients ages 0-15 presenting to Sheffield Children's Hospital with a suspected primary muscoloskeltal infection
Key inclusion criteria (6 listed)
- Children and young people from neonates to 15 years of age:
- With clinical suspicion of a primary MSK infection (irrespective of location or aetiology), as defined by presenting symptoms, physical examination and bloodwork performed by a qualified clinician.
- Presenting to Sheffield Children's Hospital via A\&E or referral from another hospital.
- Who are able to interpret the information given in the information sheet/assent form on paper in English (with the exception of children under the age of 3 years who are not required to assent.)
- With at least 1 competent legal guardian who is capable of legally consenting, and interpreting the information given in the information sheet in English.
Key exclusion criteria (7 listed)
- - Have a secondary MSK infection.
- Are severely ill or need urgent/critical attention or have comorbid conditions that will complicate their care, as decided by a medical doctor involved in their treatment.
- Patients with conditions including but not limited to leukaemia, hyper/hypothyroidism, diabetes mellitus or any other condition that affects their basal metabolic rate/body temperature.
- Amputees where the amputated region is contralateral to the region of suspected infection.
- Have received an a priori diagnosis or have already undergone any investigation. This includes patients admitted for a recurrence/exacerbation of recently diagnosed MSK infection.
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 Thermal ImagingA HRTI camera is a non-invasive medical device that will be utilised on patients that present in ED with an MSK infection. The goal of this intervention is to answer the following: Can combined HRTI and blood tests provide a higher diagnostic reliability than HRTI on its own? Can combined HRTI and artificial intelligence (AI) provide a timelier (as compared to existing modalities) detection of bone, joint and soft tissue infection thus allowing a more effective treatment? What are patients views and feedback for the new HRTI method? | Device | Non-Emergent Musculoskeletal Infection, Septic Arthritis |
Primary outcome
Thermal profile variability in affected and contralateral region of interest.
Time frame: Admission to hospital (Day 1)
On admission (Day 1), thermal images of the affected and contralateral limbs are obtained. This generates a thermal profile through which the temperature (°C) can be extracted. A region of interest is drawn around the suspected anatomical zone of the infection. This outcome measure will compare differences in the temperature (°C) of the affected and contralateral region of interest. This will include the mean temperature difference and the hottest and coldest spots in each zone, respectively.
3 secondary outcomes
Erythrocyte Sedimentation rate (ESR)
Time frame: On admission (day 1)
C-reactive protein (CRP)
Time frame: On admission (Day 1)
White blood cell count (WBC)
Time frame: On admission (day 1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Musculoskeletal Infection and Septic Arthritis, 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 6 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 4 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sanjeev Madan (+44 0114 271 7000, s.madan@sheffield.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thermal profile variability in affected and contralateral region of interest. (time frame: Admission to hospital (Day 1)). 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 4 Feb 2026.