Status:
COMPLETED
Reliability of Sensor Spacing for NIRS in Traumatic Tibia Fractures
Lead Sponsor:
Emory University
Conditions:
Orthopedic Disorders
Tibial Fractures
Eligibility:
All Genders
18-65 years
Brief Summary
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 techn...
Detailed Description
This study seeks to further develop the use of NIRS technology in the diagnosis of acute compartment syndrome. NIRS values normally increase in traumatized legs compared to the contralateral uninjured...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 20 2016
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT02301832
Start Date
December 1 2014
End Date
July 20 2016
Last Update
February 6 2017
Active Locations (1)
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1
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303