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:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2025-12-26 @ 10:56 AM
NCT ID:
NCT01327508
Eligibility Criteria:
Inclusion Criteria
* Unilateral femoral shaft fracture requiring intramedullary nailing in which the use of stereotactic surgery may be appropriate.
* Subject is between 18-80 years of age.
* Subject is skeletally mature
* Subject is of legal age and capable of providing legal consent.
* Subject is suitable for current Intramedullary Nailing procedure
* Subject willing to accept randomization either to the TRIGEN SURESHOT Distal Targeting System or TRIGEN standard instrumentation.
Exclusion Criteria
* Femur shaft fracture not amenable to intramedullary nailing in which the use of sterotactic surgery may be inappropriate.
* Fracture with vascular injury (Gustilo Type IIIC) requiring repair
* Open fractures where open wound is in communication with distal targeting holes and therefore would influence duration of locking procedure (i.e. potentially no need for incisions for locking screw placement).
* Fracture of the Metaphyseal distal femur with intraarticular comminution
* Known Pathological Fracture
* Subject is a prisoner
* Operative procedure for closed fracture is scheduled for greater than 2 weeks for closed fractures
* Subject has cognitive issue/mental status conditions that preclude intramedullary nailing in the judgment of the investigator.
* Contralateral femoral shaft fracture
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01327508
Study Brief:
Protocol Section:
NCT01327508