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 @ 11:47 AM
Ignite Modification Date:
2025-12-24 @ 11:47 AM
NCT ID:
NCT01561261
Eligibility Criteria:
Inclusion Criteria:
1. Patient between the ages of 18 and 60
2. Weight of \> 88 lb/40 kg
3. Patient presents with one of the following injuries:
* Closed tibial shaft fracture with displacement, comminution, or segmental pattern
* Closed bicondylar tibial plateau fracture or medial tibial plateau-knee dislocation
* Open tibial shaft fracture (Gustilo Type I, II or IIIA)
* Open bicondylar tibial plateau fracture or medial tibial plateau-knee dislocation (Gustilo Type I, II or IIIA)
* Severe soft tissue crush injury to lower leg
* Gun shot injury to leg
* Proximal fibula fracture
4. Injury resulted from a high-energy mechanism (e.g. pedestrian struck; fall \> 10 ft; MVA/MCA at speed \> 30 mph; injury due to shotgun, rifle, or projectile)
5. The injury occurs no more than 12 hours prior to initiation of monitoring
6. If bilateral leg injuries are present, only the limb that is most severely injured in the judgment of the investigator will be studied
7. At least one extremity must be uninjured to serve as a control for muscle oximetry
8. Patients may have other injuries except as noted below under exclusion criteria
9. Patient may have impending compartment syndrome at time of evaluation; however, the surgeon must be able to initiate monitoring and take at least one set of muscle pressures and obtain one set of tissue oxygenation measurements prior to performing fasciotomy
Exclusion Criteria:
1. Soft tissue wounds that will interfere with monitoring (i.e. the insertion of indwelling pressure catheters and/or application of NIRS pads to the anterior and deep posterior compartments of the leg)
2. Patients with known peripheral vascular disease
3. Informed consent from the patient or from a legally authorized representative (LAR) is not obtained early enough to begin monitoring within 12 hours post-injury
4. Non-ambulatory due to an associated complete spinal cord injury
5. Non-ambulatory before the injury due to a pre-existing condition
6. Patient speaks neither English nor Spanish
7. Severe problems with maintaining follow-up (e.g. patients who are homeless at the time of injury or those how are intellectually challenged without adequate family support).
8. Prior extensive traumatic injury requiring surgery to either lower extremity.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01561261
Study Brief:
Protocol Section:
NCT01561261