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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
Sheffield Children's NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Osteogenesis Imperfecta

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesDoes not accept 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

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

    First Posted
    January 3, 2020
    Last Updated
    January 15, 2020
    Sponsor
    Sheffield Children's NHS Foundation Trust
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    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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