Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:39 PM
Ignite Modification Date:
2025-12-24 @ 9:39 PM
NCT ID:
NCT02301832
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02301832
Study Brief:
Protocol Section:
NCT02301832