High Resolution Thermal Imaging to Identify Vertebral Fractures in Children and Young People With Osteogenesis Imperfecta (THERMOI)

Brittle bone disease also known as osteogenesis imperfecta (OI) is characterised by a defect in the bone tissue that leads to recurrent fractures and significant bone deformities in children. These fractures include vertebral (spinal) fractures. As a result, child with OI require regular clinic surveillance that includes repeated xrays of the spine. in our pilot study the investigators plan to use a thermal imaging camera that can pick up changes in temperature to 0.03 degrees to determine whether the investigators can accurately identify vertebral fractures without the need for radiation. in the first part of the study the investigators will compare the thermal images from the camera with the xrays to see if the investigators can pick up the vertebral fractures seen on the xray picture. If this is possible, then the investigators will move on to phase 2 of the study which will investigate the ability of the thermal camera to pick up vertebral fractures without prior knowledge of where the fractures are located. If this approach is successful this will help us to develop a nonradiation, lowcost painless way of identifying vertebral fractures in children with OI.

Study Overview

• Status: Completed
• Conditions: Osteogenesis Imperfecta
• Intervention / Treatment: Device: Thermal imaging device

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

• Patients with Osteogenesis Imperfecta (with known vertebral fractures)for phase one of the study.
• Patients with Osteogenesis Imperfecta for phase 2 of the study
• In both groups patients will be aged 5 years and over

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients aged 5-18 years; Patients with Osteogenesis Imperfecta (with known vertebral fractures)for phase one of the study. Patients with Osteogenesis Imperfecta for phase 2 of the study In both groups patients will be aged 5 years and over	Device: Thermal imaging device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thermal imaging device	The ability to pick up vertebral morphology and fractures in relation to spine X-rays	15 minutes

Collaborators and Investigators

• Sponsor: Sheffield Children's NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2015
• Primary Completion (Actual): July 7, 2016
• Study Completion (Actual): July 7, 2016

Study Registration Dates

• First Submitted: January 3, 2020
• First Submitted That Met QC Criteria: January 15, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 15, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Genetic Diseases, Inborn; Musculoskeletal Diseases; Connective Tissue Diseases; Bone Diseases; Bone Diseases, Developmental; Spinal Injuries; Back Injuries; Osteochondrodysplasias; Collagen Diseases; Spinal Fractures; Osteogenesis Imperfecta
• Other Study ID Numbers: SCH-13-067b