At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- High Resolution Thermal Imaging (device)
- How long the study runs
- Study runs about 11 months (dates as stated)
- About the drug or intervention
- High Resolution Thermal Imaging — device: A HRTI camera is a non-invasive medical device that will be utilised on patients that present in ED with an MSK infection.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- 0 Years to 15 Years
- Who
- All
- Number of participants
- 30
- Started
- 2025-02-17
- Last checked
- 2025-03
Plain English Summary
What is this study?
- • Testing a new treatment for musculoskeletal infection
- • Clinical study - 30 participants
- • 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
Who can take part?
- • Ages 0 Years to 15 Years
- • Diagnosed with musculoskeletal infection
Where?
- • Sheffield - Sheffield Children's NHS Foundatin Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 0 Years - 15 Years
- Who can join: All genders
Treatment history
Treatments you must have had:
- ✓ to assent
What the study is looking for
- ✓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...
- ✓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...
- ✓With at least 1 competent legal guardian who is capable of legally consenting, and interpreting the information...
Who cannot take part
- ✗\- Have a secondary MSK infection.
- ✗Are severely ill or need urgent/critical attention or have comorbid conditions that will complicate their care, as...
- ✗Patients with conditions including but not limited to leukaemia, hyper/hypothyroidism, diabetes mellitus or any...
- ✗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...
See the full criteria
Where Is This Study? (1 UK site)
Sheffield Children's NHS Foundatin Trust
Sheffield S10 2TH, United Kingdom
How to Get in Touch
Sanjeev Madan
Sponsor contactCONTACT
