High Resolution Thermal Imaging to Identify Vertebral Fractures in Children and Young People With Osteogenesis Imperfecta (THERMOI)
Primary Purpose
Osteogenesis Imperfecta
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Thermal imaging device
Sponsored by
About this trial
This is an interventional diagnostic trial for Osteogenesis Imperfecta
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients aged 5-18 years
Arm 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
Outcomes
Primary Outcome Measures
Thermal imaging device
The ability to pick up vertebral morphology and fractures in relation to spine X-rays
Secondary Outcome Measures
Full Information
NCT ID
NCT04231916
First Posted
January 3, 2020
Last Updated
January 15, 2020
Sponsor
Sheffield Children's NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT04231916
Brief Title
High Resolution Thermal Imaging to Identify Vertebral Fractures in Children and Young People With Osteogenesis Imperfecta
Acronym
THERMOI
Official Title
High Resolution Thermal Imaging to Identify Vertebral Fractures in Children and Young People With Osteogenesis Imperfecta
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
October 23, 2015 (Actual)
Primary Completion Date
July 7, 2016 (Actual)
Study Completion Date
July 7, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheffield Children's NHS Foundation Trust
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteogenesis Imperfecta
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients aged 5-18 years
Arm Type
Experimental
Arm 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
Intervention Type
Device
Intervention Name(s)
Thermal imaging device
Primary Outcome Measure Information:
Title
Thermal imaging device
Description
The ability to pick up vertebral morphology and fractures in relation to spine X-rays
Time Frame
15 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
12. IPD Sharing Statement
Learn more about this trial
High Resolution Thermal Imaging to Identify Vertebral Fractures in Children and Young People With Osteogenesis Imperfecta
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