TRIGEN SURESHOT™ Distal Targeting System Study

The TRIGEN SURESHOT™ Distal Targeting System was designed to be an intraoperative
image-guided localization system to aid with drill positioning for screws during
intramedullary nailing distal interlocking. It is hypothesized that this system will aid in
identification of the distal holes leading to reduced exposure to radiation. The SURESHOT
System provides information to the surgeon that is used to place surgical instruments
utilizing electromagnetic tracking data obtained intraoperatively. It is indicated for long
bone fractures treated with intramedullary nailing in which the use of stereotactic surgery
may be appropriate. The hypothesis is that using the TRIGEN SURESHOT™ Distal Targeting System
will allow accurate distal locking while effectively decreasing the amount of radiation
exposure compared to the standard instrumentation process.

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