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TRIGEN SURESHOT™ Distal Targeting System Study

NCT01327508 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-03-14

Study results available
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Summary

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.

Conditions

  • Femoral Shaft Fracture

Interventions

DEVICE

TRIGEN SURESHOT Distal Targeting Instrumentation.

image-guided localization system

OTHER

Free-hand technique

Free-hand technique utilizes x-rays to find screw holes.

Sponsors & Collaborators

  • Smith & Nephew, Inc.

    lead INDUSTRY

Principal Investigators

  • Samir Mehta, M.D. · Orthopaedic Surgery, Hospital of the University of Pennsylvania

  • Animesh Agarwal, M.D. · UT Health Science Center, Dept of Orthopaedic

  • Marcus Sciadini, M.D · University of Maryland Baltimore, Department of Orthopaedics

  • Steven Olson, M.D. · Duke University Medical Center of Orthopaedic

  • Chad Coles, M.D. · Nova Scotia Health Authority

  • Richard Vlasak, M.D. · Dept. of Orthopaedics & Rehab University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2013-01-31
Completion
2013-06-30

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01327508 on ClinicalTrials.gov