Acute FractureNCT04197505
Application of Forward-looking Infrared for the Identification and Evaluation of Fractures in the Acute Trauma Setting
A study testing FLIR E95 camera in people with Acute Fracture, run by NYU Langone Health.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Acute Fracture
- What is being tested?
- FLIR E95 camera
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2022to Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged 18 to 95
- Have fracture injury
Who cannot join
- 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
About this study
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.
Read the 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.
- Conditions
- Acute Fracture
- Being tested
- FLIR E95 camera
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLIR E95 cameraBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Acute fracture specific | Experimental | 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. Receives: Behavioral: FLIR E95 camera |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through study completion, an average of 18 months
Secondary outcomes (1)
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
Measured: through study completion, an average of 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study startJan 2022 (estimated)
- Primary completionJul 2024 (estimated)
- Study completionJul 2024 (estimated)
Why it stopped: Lost funding due to COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute FractureStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philipp Leucht, Principal investigator, NYU Langone
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04197505
- Sponsor's protocol ID
- 19-01424
- Status last verified
- Oct 2021
- First submitted
- 11 Dec 2019
- Last updated
- 11 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Forward-looking Infrared for the Identification and Evaluation of Fractures in the Acute Trauma Setting
- ClinicalTrials.gov ID
- NCT04197505
- Acronym / sponsor ID
- 19-01424
- Conditions
- Acute Fracture
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lost funding due to COVID-19
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Jan 2022 (estimated)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 13 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute fracture specific | Experimental | Behavioral: FLIR E95 cameraThe 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients aged 18 to 95
- Have fracture injury
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FLIR E95 cameraVideo 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. | Behavioural | Acute fracture specific |
Primary outcome
Comparison of thermal imaging of extremity with and without fracture
Time frame: through study completion, an average of 18 months
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
1 secondary outcome
Change in thermal imaging predicting non-union
Time frame: through study completion, an average of 18 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2021.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philipp Leucht principal investigator
NYU Langone
Questions about this trial
What is this clinical trial studying?
A study testing FLIR E95 camera in people with Acute Fracture, run by NYU Langone Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of thermal imaging of extremity with and without fracture (time frame: through study completion, an average of 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2021.