Hi-Res IR Thermography for the Diagnosis of Toddler's Fractures

NCT05536622 | Unknown

• 1 other identifier: SCH-2528
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Fractures, Bone

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (2)

• Effective recruitment strategy

  12 months

• Identification of relevant Parent related experience measures

  12 months

Study Arms (1)

Infrared imaging of affected tibia

EXPERIMENTAL

All eligible children will have infrared imaging undertaken of both affected limb and unaffected limb simultaneously.

Diagnostic Test: High resolution infrared imaging

Interventions

High resolution infrared imaging DIAGNOSTIC_TEST

High resolution infrared imaging of limb of concern and unaffected limb (control).

Infrared imaging of affected tibia

Eligibility Criteria

• Age: 9 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Significant pain or discomfort (requiring second line analgesia as defined by ED guidelines)
• Multiple injuries (not localised to a single lower limb)

Sponsors & Collaborators

• Sheffield Children's NHS Foundation Trust: lead

Study Sites (1)

Clinical Research Facility, Sheffield Children's Hospital

Sheffield, S10 2TH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Shammi Ramlakhan

  Sheffield Children's NHS Trust

  STUDY DIRECTOR

Central Study Contacts

Keith Pugh

CONTACT

0114 3053478; keith.pugh1@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2021
• First Posted: September 13, 2022
• Study Start: February 11, 2021
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: September 13, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)