TRIGEN SURESHOT™ Distal Targeting System Study

Not Applicable

Terminated

• Conditions: Femoral Shaft Fracture
• Interventions: Device: TRIGEN SURESHOT Distal Targeting Instrumentation.; Other: Free-hand technique

• Registration Number: NCT01327508
• Lead Sponsor: Smith & Nephew, Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2011-03-30
• Study First Submitted QC: 2011-03-31
• Study Start: 2011-04
• Study First Posted: 2011-04-01
• Primary Completion: 2013-01
• Study Completion: 2013-06
• Results First Submitted: 2014-06-06
• Results First Submitted QC: 2016-01-05
• Results First Posted: 2016-02-09
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-14
• Last Update Posted: 2018-03-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TRIGEN SURESHOT Distal Targeting	TRIGEN SURESHOT Distal Targeting Instrumentation.	TRIGEN SURESHOT Distal Targeting Instrumentation is utilized to find screw holes.
Standard Nailing Instrumentation.	Free-hand technique	Free-hand technique utilizes x-rays to find screw holes

Primary Outcome Measures

Name	Time	Method
Radiation Exposure Measurement	Intraoperative	Radiation exposure measured in two ways: Whole body badge TLD ring badge

Secondary Outcome Measures

Name	Time	Method
Distal Locking Time	Intraoperative	Distal locking time is defined as the period between successful nail insertion without locking and the confirmation of accurate insertion of both distal screws.

Trial Locations

Locations (7)

UC Davis Medical Center; 🇺🇸 Sacramento, California, United States

University of Maryland Medical Center; 🇺🇸 Baltimore, Maryland, United States

Capital District Health Authority; 🇨🇦 Halifax, Nova Scotia, Canada

Department of Orthopaedics and Rehabilitation; 🇺🇸 Gainesville, Florida, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

University Hospital Trauma Service; 🇺🇸 San Antonio, Texas, United States