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TRIGEN SURESHOT™ Distal Targeting System Study (Sureshot)

This study has been terminated.
(Primary endpoint voided. Dosimeters did not capture radiation dose as expected.)
Information provided by (Responsible Party):
Smith & Nephew, Inc. Identifier:
First received: March 30, 2011
Last updated: January 5, 2016
Last verified: January 2016
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.

Condition Intervention Phase
Femoral Shaft Fracture
Device: TRIGEN SURESHOT Distal Targeting Instrumentation.
Other: Free-hand technique
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Prospective, Multi-center, Randomized, Comparison Study of the TRIGEN SURESHOT™ Distal Targeting vs. Standard Targeting Instrumentation

Further study details as provided by Smith & Nephew, Inc.:

Primary Outcome Measures:
  • Radiation Exposure Measurement [ Time Frame: Intraoperative ]

    Radiation exposure measured in two ways:

    Whole body badge TLD ring badge

Secondary Outcome Measures:
  • 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.

Enrollment: 60
Study Start Date: April 2011
Study Completion Date: June 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

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.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01327508

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

Responsible Party: Smith & Nephew, Inc. Identifier: NCT01327508     History of Changes
Other Study ID Numbers: 09-TRI-01
Study First Received: March 30, 2011
Results First Received: June 6, 2014
Last Updated: January 5, 2016 processed this record on May 25, 2017