TRIGEN SURESHOT™ Distal Targeting System Study

Femoral Shaft Fracture Clinical Trial

— Sureshot  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01327508
• Other study ID #: 09-TRI-01
• Status: Terminated
• Phase: N/A
• First received: March 30, 2011
• Last updated: February 14, 2018
• Start date: April 2011
• Est. completion date: June 2013

Study information

• Verified date: February 2018
• Source: Smith & Nephew, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: June 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Femoral Shaft Fracture

Intervention

Device:
• TRIGEN SURESHOT Distal Targeting Instrumentation.
image-guided localization system

Other:
• Free-hand technique
Free-hand technique utilizes x-rays to find screw holes.

Locations

Country	Name	City	State
Canada	Capital District Health Authority	Halifax	Nova Scotia
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	Duke University Medical Center	Durham	North Carolina
United States	Department of Orthopaedics and Rehabilitation	Gainesville	Florida
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	UC Davis Medical Center	Sacramento	California
United States	University Hospital Trauma Service	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiation Exposure Measurement	Radiation exposure measured in two ways: Whole body badge TLD ring badge	Intraoperative
Secondary	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