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

Osteogenesis Imperfecta Clinical Trial

— THERMOI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04231916
• Other study ID #: SCH-13-067b
• Status: Completed
• Phase: N/A
• Start date: October 23, 2015
• Est. completion date: July 7, 2016

Study information

• Verified date: January 2020
• Source: Sheffield Children's NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: July 7, 2016
• Est. primary completion date: July 7, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

• 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

Related Conditions & MeSH terms

• Osteogenesis Imperfecta
• Spinal Fractures

Intervention

Device:
• Thermal imaging device

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sheffield Children's NHS Foundation Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thermal imaging device	The ability to pick up vertebral morphology and fractures in relation to spine X-rays	15 minutes