NCT05536622

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

Status unknown NA Last updated 13 September 2022

What this trial tests

NA trial testing High resolution infrared imaging in Fractures, Bone in 50 participants. Status unknown.

Timeline

11 February 2021

Primary endpoint
30 September 2022

30 September 2022

Quick facts

Lead sponsor	Sheffield Children's NHS Foundation Trust
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	50
Start date	11 February 2021
Primary completion	30 September 2022
Estimated completion	30 September 2022
Sites	1 location across United Kingdom

Drugs / interventions tested

• High resolution infrared imaging

Conditions studied

• Fractures, Bone — all drugs for Fractures, Bone →

Sponsor

Sheffield Children's NHS Foundation Trust

Who can join

Adults 9 Months to 5, any sex, with Fractures, Bone. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.