TRIGEN SURESHOT™ Distal Targeting System Study

Study Overview
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Brief Summary
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The objective of this study is to quantitate the amount of radiation both subjects and surgeons are exposed to during intramedullary nailing of the femur using the TRIGEN SURESHOT Distal Targeting System versus Standard nailing instrumentation.

Detailed Description
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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.

Official Title
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A Prospective, Multi-center, Randomized, Comparison Study of the TRIGEN SURESHOT™ Distal Targeting vs. Standard Targeting Instrumentation

Conditions
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Femoral Shaft Fracture

Intervention / Treatment
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* Device: TRIGEN SURESHOT Distal Targeting Instrumentation.
* Other: Free-hand technique


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TRIGEN SURESHOT Distal Targeting<br>TRIGEN SURESHOT Distal Targeting Instrumentation is utilized to find screw holes. | Device: TRIGEN SURESHOT Distal Targeting Instrumentation.<br>* image-guided localization system<br>* Other names: SURESHOT;|
| Active Comparator: Standard Nailing Instrumentation.<br>Free-hand technique utilizes x-rays to find screw holes | Other: Free-hand technique<br>* Free-hand technique utilizes x-rays to find screw holes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiation Exposure Measurement | Radiation exposure measured in two ways: Whole body badge TLD ring badge | Intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distal Locking Time | Distal locking time is defined as the period between successful nail insertion without locking and the confirmation of accurate insertion of both distal screws. | Intraoperative |