TRIGEN SURESHOT™ Distal Targeting System Study (Sureshot)

This study has been terminated.
(Primary endpoint voided. Dosimeters did not capture radiation dose as expected.)
Sponsor:
Information provided by (Responsible Party):
Smith & Nephew, Inc.
ClinicalTrials.gov Identifier:
NCT01327508
First received: March 30, 2011
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • radiation exposure measurement [ Time Frame: Intraoperative ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Distal Locking Time [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]

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 IMN 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 IMN 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Unilateral femoral shaft fracture requiring intramedullary nailing in which the use of sterotactic 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 IMN 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 (Gustillo 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01327508

Locations
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.
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. Capital District Health Authority, Canada
Principal Investigator: Richard Vlasak, M.D. Dept. of Orthopaedics & Rehab University of Florida
  More Information

No publications provided

Responsible Party: Smith & Nephew, Inc.
ClinicalTrials.gov Identifier: NCT01327508     History of Changes
Other Study ID Numbers: 09-TRI-01
Study First Received: March 30, 2011
Last Updated: May 21, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Leg Injuries

ClinicalTrials.gov processed this record on September 22, 2014