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

Sponsor

Sheffield Children's NHS Foundation Trust (Other)

Overall Status

Completed

CT.gov ID

NCT04231916

Collaborator

(none)

Enrollment

Arm

8.5

Actual Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Osteogenesis Imperfecta	Device: Thermal imaging device	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

11 participants

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Oct 23, 2015

Actual Primary Completion Date :

Jul 7, 2016

Actual Study Completion Date :

Jul 7, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Thermal imaging device [15 minutes]
The ability to pick up vertebral morphology and fractures in relation to spine X-rays

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Sheffield Children's NHS Foundation Trust

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sheffield Children's NHS Foundation Trust

ClinicalTrials.gov Identifier:

NCT04231916

Other Study ID Numbers:

SCH-13-067b

First Posted:

Jan 18, 2020

Last Update Posted:

Jan 18, 2020

Last Verified:

Jan 1, 2020

Additional relevant MeSH terms:

Osteogenesis Imperfecta

Spinal Fractures

Study Results

No Results Posted as of Jan 18, 2020