HiRes Infrared Imaging for Wrist Injuries in Children v2

NCT05892484 | Completed

• 1 other identifier: SCH-2323
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Fractures, Bone

Outcome Measures

Primary Outcomes (2)

• The Accuracy of Thermal Imaging to Detect Fractures

  Percentage of fractures correctly identified by Thermal Imaging.

  12 months

• Diagnostic accuracy of Thermal Imaging

  Sensitivity and Specificity of thermal imaging in identifying or excluding fractures

  12 months

Study Arms (2)

Thermal Imaging

EXPERIMENTAL

Participants will receive thermal imaging in addition to their routine x-ray for comparison.

Device: Thermal Imaging

X-ray

OTHER

Routine x-ray is what the active comparator is being evaluated against.

Diagnostic Test: X-RAY

Interventions

Thermal Imaging DEVICE

Thermal Imaging device used to evaluate fracture in those presenting with proposed wrist fracture in the emergency department.

Thermal Imaging

X-RAY DIAGNOSTIC_TEST

Routine X-RAY

X-ray

Eligibility Criteria

• Age: 5 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sheffield Children's NHS Foundation Trust: lead

Study Sites (1)

Clinical Research Facility, Sheffield Children's Hospital

Sheffield, S10 2TH, United Kingdom

Location

MeSH Terms

Conditions

Fractures, Bone

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Officials

• Shammi Ramlakhan

  Sheffield Children's NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: If the thermal imaging is done first, the radiographer taking the x-ray won't be informed of the outcome of the imaging assessment, so two independent assessments can be compared.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Comparison between thermal imaging and x-ray.

Study Record Dates

• First Submitted: June 4, 2021
• First Posted: June 7, 2023
• Study Start: March 13, 2019
• Primary Completion: August 31, 2019
• Study Completion: November 13, 2019
• Last Updated: June 7, 2023

Record last verified: 2023-06

Locations

GB (1)