Application of Forward-looking Infrared for the Identification and Evaluation of Fractures in the Acute Trauma Setting
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- NYU Langone Health
- Primary Endpoint
- Comparison of thermal imaging of extremity with and without fracture
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Change in thermal imaging predicting non-union(through study completion, an average of 18 months)