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 @ 3:42 PM
Ignite Modification Date:
2025-12-24 @ 3:42 PM
NCT ID:
NCT05947292
Eligibility Criteria:
Inclusion Criteria:
* Acute femur fracture (less than 24 hours from initial injury)
* Glasgow Coma Scale of 14 or greater at time of enrollment
Exclusion Criteria:
* Allergy or hypersensitivity to local anesthetic agents
* Pregnant
* Prisoner
* Neurovascular injury to the affected limb
* Bilateral femur fractures
* Confirmed, or significant clinical suspicion for, injury to their head, neck, chest, abdomen, back or pelvis
* Imaging suggestive of a head, neck, chest, abdomen, back or pelvic injury
* Laboratory results suggestive of a head, neck, chest, abdomen, back or pelvic injury
* A fracture not limited to the extremities (i.e. vertebral compression fracture)
* A significantly displaced extremity fractures (aside from the primary femur fracture)
* An open fracture (aside from the primary femur fracture)
* An additional fracture to the limb of the primary femur fracture (i.e. tibia fracture in the same leg as the primary femur fracture).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
17 Years
Study:
NCT05947292
Study Brief:
Protocol Section:
NCT05947292