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HiRes Infrared Imaging for Wrist Injuries in Children v2

Primary Purpose

Fractures, Bone

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Thermal Imaging
X-RAY
Sponsored by
Sheffield Children's NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Fractures, Bone

Eligibility Criteria

5 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • Clinical Research Facility, Sheffield Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Thermal Imaging

X-ray

Arm Description

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

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

Outcomes

Primary Outcome Measures

The Accuracy of Thermal Imaging to Detect Fractures
Percentage of fractures correctly identified by Thermal Imaging.
Diagnostic accuracy of Thermal Imaging
Sensitivity and Specificity of thermal imaging in identifying or excluding fractures

Secondary Outcome Measures

Full Information

First Posted
June 4, 2021
Last Updated
June 6, 2023
Sponsor
Sheffield Children's NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT05892484
Brief Title
HiRes Infrared Imaging for Wrist Injuries in Children v2
Official Title
High Resolution Infrared Thermography as a Diagnostic Aid in Paediatric Wrist Injuries Version 2
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
March 13, 2019 (Actual)
Primary Completion Date
August 31, 2019 (Actual)
Study Completion Date
November 13, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheffield Children's NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fractures, Bone

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Comparison between thermal imaging and x-ray.
Masking
Care Provider
Masking Description
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.
Allocation
Non-Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Thermal Imaging
Arm Type
Experimental
Arm Description
Participants will receive thermal imaging in addition to their routine x-ray for comparison.
Arm Title
X-ray
Arm Type
Other
Arm Description
Routine x-ray is what the active comparator is being evaluated against.
Intervention Type
Device
Intervention Name(s)
Thermal Imaging
Intervention Description
Thermal Imaging device used to evaluate fracture in those presenting with proposed wrist fracture in the emergency department.
Intervention Type
Diagnostic Test
Intervention Name(s)
X-RAY
Intervention Description
Routine X-RAY
Primary Outcome Measure Information:
Title
The Accuracy of Thermal Imaging to Detect Fractures
Description
Percentage of fractures correctly identified by Thermal Imaging.
Time Frame
12 months
Title
Diagnostic accuracy of Thermal Imaging
Description
Sensitivity and Specificity of thermal imaging in identifying or excluding fractures
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shammi Ramlakhan
Organizational Affiliation
Sheffield Children's NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Research Facility, Sheffield Children's Hospital
City
Sheffield
ZIP/Postal Code
S10 2TH
Country
United Kingdom

12. IPD Sharing Statement

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HiRes Infrared Imaging for Wrist Injuries in Children v2

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