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

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ClinicalTrials.gov Identifier: NCT04231916
Recruitment Status : Completed
First Posted : January 18, 2020
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Sheffield Children's NHS Foundation Trust

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : October 23, 2015
Actual Primary Completion Date : July 7, 2016
Actual Study Completion Date : July 7, 2016


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



Primary Outcome Measures :
  1. Thermal imaging device [ Time Frame: 15 minutes ]
    The ability to pick up vertebral morphology and fractures in relation to spine X-rays



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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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Responsible Party: Sheffield Children's NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04231916    
Other Study ID Numbers: SCH-13-067b
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Additional relevant MeSH terms:
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Osteogenesis Imperfecta
Spinal Fractures
Osteochondrodysplasias
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn
Collagen Diseases
Connective Tissue Diseases
Spinal Injuries
Back Injuries
Wounds and Injuries
Fractures, Bone