TRIGEN SURESHOT™ Distal Targeting System Study (Sureshot)

February 14, 2018 updated by: Smith & Nephew, Inc.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Capital District Health Authority
  • United States
    • California
      • Sacramento, California, United States, 95817
        • UC Davis Medical Center
    • Florida
      • Gainesville, Florida, United States, 32607
        • Department of Orthopaedics and Rehabilitation
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Medical Center
    • North Carolina
      • Durham, North Carolina, United States, 27707
        • Duke University Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania
    • Texas
      • San Antonio, Texas, United States, 78229
        • University Hospital Trauma Service

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiation Exposure Measurement
Time Frame: Intraoperative

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
Time Frame: 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.
Intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Smith & Nephew, Inc.

Investigators

  • Principal Investigator: Samir Mehta, M.D., Orthopaedic Surgery, Hospital of the University of Pennsylvania
  • Principal Investigator: Animesh Agarwal, M.D., UT Health Science Center, Dept of Orthopaedic
  • Principal Investigator: Marcus Sciadini, M.D, University of Maryland Baltimore, Department of Orthopaedics
  • Principal Investigator: Steven Olson, M.D., Duke University Medical Center of Orthopaedic
  • Principal Investigator: Chad Coles, M.D., Nova Scotia Health Authority
  • Principal Investigator: Richard Vlasak, M.D., Dept. of Orthopaedics & Rehab University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

March 30, 2011

First Submitted That Met QC Criteria

March 31, 2011

First Posted (Estimate)

April 1, 2011

Study Record Updates

Last Update Posted (Actual)

March 14, 2018

Last Update Submitted That Met QC Criteria

February 14, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 09-TRI-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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