NCT01327508

TRIGEN SURESHOT™ Distal Targeting System Study

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Smith & Nephew, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Femoral Shaft Fracture

Interventions

Type	Name	Description
DEVICE	TRIGEN SURESHOT Distal Targeting Instrumentation.	image-guided localization system
OTHER	Free-hand technique	Free-hand technique utilizes x-rays to find screw holes.

Timeline

• Start date: 2011-04-01
• Primary completion: 2013-01-01
• Completion: 2013-06-01
• First posted: 2011-04-01
• Last updated: 2018-03-14
• Results posted: 2016-02-09

Locations

7 sites across 2 countries: United States, Canada