Reliability of Sensor Spacing for NIRS in Traumatic Tibia Fractures

Completed

Conditions studied: Orthopedic Disorders, Tibial Fractures

In brief

This is a study intended to evaluate a non-invasive device that uses light to measure the amount of oxygen in the muscles of injured and non-injured legs in specific situations. The name of this technology is NIRS (near-infrared spectroscopy). The goal of this study is to collect the information necessary to understand the use of the NIRS monitoring system to diagnose and direct treatment decisions in case of complications sometimes experienced in traumatic tibia fracture, such as excessive swelling called acute compartment syndrome (ACS).

Key facts

Study ID

NCT02301832

Run by

Emory University

People needed

14

Starts

2014-12-01

Expected to finish

2016-07-20

Last updated by the study team

2017-02-06

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Unilateral leg injury
• Enrolled within 48 hours of injury
• Subjects with 'severe' leg injuries presenting at trauma center that meet at least one of the following from each group below:
• Anatomic location:
• Tibia/Fibula shaft fracture
• Tibial plateau fracture (Schatzker III-VI)
• High Energy Mechanism of Injury:
• Fall from >8 foot height
• Motor vehicle collision (> 15 mph)
• Motor vehicle versus pedestrian accident
• High velocity gunshot wound
• Crush injury
• Sport/recreation

You may not qualify if…

• Application of NIRS monitoring would be an impediment to care
• Known prior leg fractures, patient has already undergone fasciotomy of the injured leg prior to enrollment
• History of peripheral vascular disease or concurrent lower extremity vascular injury/surgery
• Admission for atraumatic medical reasons
• Subject is unable to provide informed consent, or consent cannot be obtained from a legally authorized representative
• Complete spinal cord injuries, bilateral upper extremity injuries, or amputation/mangled lower extremity
• Patients who are in police custody at presentation to the hospital or who are pregnant
• Patient has an open injury on the injured leg that is large enough that at least one NIRS sensor cannot be safely placed over the compartment
• Bilateral leg injuries
• Not able to be enrolled within 48 hours after injury

Where it is running

• Grady Memorial Hospital — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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