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

NCT ID: NCT04231916

Last Updated: 2020-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-23
• Study Completion Date: 2016-07-07

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.

Conditions

Osteogenesis Imperfecta

Study Design

• Intervention Model: SEQUENTIAL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Thermal imaging device

Intervention Type: DEVICE

Interventions

Thermal imaging device

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheffield Children's NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

SCH-13-067b

Identifier Type: -

Identifier Source: org_study_id