Study Results
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View full resultsBasic Information
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TERMINATED
NA
60 participants
INTERVENTIONAL
2011-04-30
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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TRIGEN SURESHOT Distal Targeting
TRIGEN SURESHOT Distal Targeting Instrumentation is utilized to find screw holes.
TRIGEN SURESHOT Distal Targeting Instrumentation.
image-guided localization system
Standard Nailing Instrumentation.
Free-hand technique utilizes x-rays to find screw holes
Free-hand technique
Free-hand technique utilizes x-rays to find screw holes.
Interventions
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TRIGEN SURESHOT Distal Targeting Instrumentation.
image-guided localization system
Free-hand technique
Free-hand technique utilizes x-rays to find screw holes.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Smith & Nephew, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Samir Mehta, M.D.
Role: PRINCIPAL_INVESTIGATOR
Orthopaedic Surgery, Hospital of the University of Pennsylvania
Animesh Agarwal, M.D.
Role: PRINCIPAL_INVESTIGATOR
UT Health Science Center, Dept of Orthopaedic
Marcus Sciadini, M.D
Role: PRINCIPAL_INVESTIGATOR
University of Maryland Baltimore, Department of Orthopaedics
Steven Olson, M.D.
Role: PRINCIPAL_INVESTIGATOR
Duke University Medical Center of Orthopaedic
Chad Coles, M.D.
Role: PRINCIPAL_INVESTIGATOR
Nova Scotia Health Authority
Richard Vlasak, M.D.
Role: PRINCIPAL_INVESTIGATOR
Dept. of Orthopaedics & Rehab University of Florida
Locations
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UC Davis Medical Center
Sacramento, California, United States
Department of Orthopaedics and Rehabilitation
Gainesville, Florida, United States
University of Maryland Medical Center
Baltimore, Maryland, 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
Capital District Health Authority
Halifax, Nova Scotia, Canada
Countries
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Other Identifiers
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09-TRI-01
Identifier Type: -
Identifier Source: org_study_id
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