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Application of Forward-looking Infrared for the Identification and Evaluation of Fractures in the Acute Trauma Setting

Primary Purpose

Acute Fracture

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
FLIR E95 camera
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Fracture

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult patients aged 18 to 95
  • Have fracture injury

Exclusion Criteria:

  • Subjects suffering from a hypothermia- or hyperthermia - related illness or other environmental exposure-type illness
  • Those with a concomitant fracture
  • Subjects with no specific medical history or surgical history
  • Subjects who cannot provide informed consent

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Acute fracture specific

    Arm Description

    The FLIR E95 camera will be used for the study. The injured extremity will be scanned with the thermal camera and a second scan will be performed on the non-injured extremity to provide an internal control for any differences in room temperature and humidity. Prior to scanning, both the injured and non-injured extremity will remain uncovered for 10 minutes, about the length of an average office visit, and the areas to be scanned will remain free from contact by the patient or interviewer during this time period. The camera will be held 2 feet away from the extremity at a 90º angle to limit reading contamination from objects other than the patient.

    Outcomes

    Primary Outcome Measures

    Comparison of thermal imaging of extremity with and without fracture
    The FLIR E95 thermal imaging camera will be used to obtain a temperature evaluation of the injury site. The extremity with the underlying fracture will have a higher temperature reading when compared to the contralateral extremity without a fracture. Thermal imaging was selected for the proposed work due to its feasibility and potential to be a useful tool in the acute trauma setting. A thermal imaging camera detects infrared radiation and converts it to visible light. The FLIR E95 utilizes a class two laser with an output power below 1mW and this laser is considered safe without a skin or materials burn hazard unless a person deliberately stares into the beam

    Secondary Outcome Measures

    Change in thermal imaging predicting non-union
    Using the FLIR E95 thermal imaging camera, to monitor progression of fracture healing and identify patients proceeding towards a non-union. A fracture proceeding towards a non-union will have a persistently higher local temperature compared to an appropriately healing fracture. Thermal imaging was selected for the proposed work due to its feasibility and potential to be a useful tool in the acute trauma setting. A thermal imaging camera detects infrared radiation and converts it to visible light. The FLIR E95 utilizes a class two laser with an output power below 1mW and this laser is considered safe without a skin or materials burn hazard unless a person deliberately stares into the beam

    Full Information

    First Posted
    December 11, 2019
    Last Updated
    October 4, 2021
    Sponsor
    NYU Langone Health
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04197505
    Brief Title
    Application of Forward-looking Infrared for the Identification and Evaluation of Fractures in the Acute Trauma Setting
    Official Title
    Application of Forward-looking Infrared for the Identification and Evaluation of Fractures in the Acute Trauma Setting
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Lost funding due to COVID-19
    Study Start Date
    January 2022 (Anticipated)
    Primary Completion Date
    July 2024 (Anticipated)
    Study Completion Date
    July 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    NYU Langone Health

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The overall objective of this study is to (1) determine whether thermal imaging can be used during an acute trauma patient's secondary or tertiary survey to identify injury sites with an underlying fracture, and to (2) investigate whether thermal imaging can predict those patients whose fractures will result in a non-union.
    Detailed Description
    Human subjects will be enrolled into the study from NYU Langone Health and Bellevue Hospital Center. When orthopaedic surgery is consulted for management of a fracture, the patient will be offered enrollment into the study. The collected data will be assigned a letter and number associated for references with the patient's age, type of fracture, and time since original injury to thermal imaging scan. If any patient receives a thermal imaging scan at their initial injury evaluation, then he or she will also receive thermal imaging scans at all follow-up appointments to track changes in temperature over the healing process. No obtunded or unresponsive patients will be enrolled into the study. The goal will be to have to thirty patients enrolled into both acute fracture and non-union arms of the proposal for a total of sixty subjects. Age, gender, ethnicity, smoking status, medical history, and surgical history will be recorded for future confounding analysis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Fracture

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Acute fracture specific
    Arm Type
    Experimental
    Arm Description
    The FLIR E95 camera will be used for the study. The injured extremity will be scanned with the thermal camera and a second scan will be performed on the non-injured extremity to provide an internal control for any differences in room temperature and humidity. Prior to scanning, both the injured and non-injured extremity will remain uncovered for 10 minutes, about the length of an average office visit, and the areas to be scanned will remain free from contact by the patient or interviewer during this time period. The camera will be held 2 feet away from the extremity at a 90º angle to limit reading contamination from objects other than the patient.
    Intervention Type
    Behavioral
    Intervention Name(s)
    FLIR E95 camera
    Intervention Description
    Video will be recorded during the thermal reading for later computer analysis. The following variables will be analyzed: (1) the difference between the mean temperature between the injured and healthy extremities, (2) the difference between the maximum temperatures of both the injured and healthy extremities (ΔTmax), and (3) the difference between the area covered by each isotherm in both the injured and uninjured extremities (Δpix). FLIR software tools and MATLAB software will be used for the analysis.
    Primary Outcome Measure Information:
    Title
    Comparison of thermal imaging of extremity with and without fracture
    Description
    The FLIR E95 thermal imaging camera will be used to obtain a temperature evaluation of the injury site. The extremity with the underlying fracture will have a higher temperature reading when compared to the contralateral extremity without a fracture. Thermal imaging was selected for the proposed work due to its feasibility and potential to be a useful tool in the acute trauma setting. A thermal imaging camera detects infrared radiation and converts it to visible light. The FLIR E95 utilizes a class two laser with an output power below 1mW and this laser is considered safe without a skin or materials burn hazard unless a person deliberately stares into the beam
    Time Frame
    through study completion, an average of 18 months
    Secondary Outcome Measure Information:
    Title
    Change in thermal imaging predicting non-union
    Description
    Using the FLIR E95 thermal imaging camera, to monitor progression of fracture healing and identify patients proceeding towards a non-union. A fracture proceeding towards a non-union will have a persistently higher local temperature compared to an appropriately healing fracture. Thermal imaging was selected for the proposed work due to its feasibility and potential to be a useful tool in the acute trauma setting. A thermal imaging camera detects infrared radiation and converts it to visible light. The FLIR E95 utilizes a class two laser with an output power below 1mW and this laser is considered safe without a skin or materials burn hazard unless a person deliberately stares into the beam
    Time Frame
    through study completion, an average of 18 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adult patients aged 18 to 95 Have fracture injury Exclusion Criteria: Subjects suffering from a hypothermia- or hyperthermia - related illness or other environmental exposure-type illness Those with a concomitant fracture Subjects with no specific medical history or surgical history Subjects who cannot provide informed consent
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Philipp Leucht
    Organizational Affiliation
    NYU Langone
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
    IPD Sharing Time Frame
    Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
    IPD Sharing Access Criteria
    The investigator who proposed to use the data.Upon reasonable request. Requests should be directed to john.dankert@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

    Learn more about this trial

    Application of Forward-looking Infrared for the Identification and Evaluation of Fractures in the Acute Trauma Setting

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