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

NCT05536622 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-09-13

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

High resolution infrared imaging

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

Sponsors & Collaborators

  • Sheffield Children's NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Shammi Ramlakhan · Sheffield Children's NHS Trust

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
9 Months
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-11
Primary Completion
2022-09-30
Completion
2022-09-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05536622 on ClinicalTrials.gov