TRIGEN SURESHOT™ Distal Targeting System Study

Stopped early · Not applicable

Conditions studied: Femoral Shaft Fracture

In brief

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.

Key facts

Study ID

NCT01327508

Run by

Smith & Nephew, Inc.

People needed

60

Starts

2011-04-01

Expected to finish

2013-06-01

Last updated by the study team

2018-03-14

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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