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

NYU Langone Health

Status: Withdrawn

Conditions: Acute Fracture

Treatments: Behavioral: FLIR E95 camera

Study type: Interventional

Funder types: Other

Identifiers

NCT04197505

19-01424

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 19+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Acute fracture specific

Experimental group

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.

Treatment:

Behavioral: FLIR E95 camera