Loading clinical trials...
Loading clinical trials...
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.
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.
Age
18 - 80 years
Sex
ALL
Healthy Volunteers
No
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
Start Date
April 1, 2011
Primary Completion Date
January 1, 2013
Completion Date
June 1, 2013
Last Updated
March 14, 2018
60
ACTUAL participants
TRIGEN SURESHOT Distal Targeting Instrumentation.
DEVICE
Free-hand technique
OTHER
Lead Sponsor
Smith & Nephew, Inc.
NCT06658379
NCT06078371
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions