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

Acute Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04197505
• Other study ID #: 19-01424
• Status: Withdrawn
• Phase: N/A
• Start date: January 2022
• Est. completion date: July 2024

Study information

• Verified date: October 2021
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 non-union.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Fracture
• Fractures, Bone

Intervention

Behavioral:
• FLIR E95 camera
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 (?Tmax), and (3) the difference between the area covered by each isotherm in both the injured and uninjured extremities (?pix). FLIR software tools and MATLAB software will be used for the analysis.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	through study completion, an average of 18 months
Secondary	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	through study completion, an average of 18 months