Clinical Research Directory
Browse clinical research sites, groups, and studies.
Assessment of Fixation Strategies for Severe Open Tibia Fractures
Sponsor: Major Extremity Trauma Research Consortium
Summary
The purpose of this study is to compare the use of modern ring external fixation versus internal fixation for fracture stabilization of severe open tibia fractures.
Official title: A Prospective Randomized Trial to Assess Fixation Strategies for Severe Open Tibia Fractures:Modern Ring External Fixators Versus Internal Fixation
Key Details
Gender
All
Age Range
18 Years - 64 Years
Study Type
INTERVENTIONAL
Enrollment
442
Start Date
2011-07
Completion Date
2018-09
Last Updated
2026-05-26
Healthy Volunteers
No
Interventions
Surgery with an external ring fixator
Modern ring external fixator is defined as any fixator that has at least 1 ring proximal and 1 ring distal to the fracture site. The rings may be connected to the tibia using any combination of external fixation pins or wires at the surgeon's discretion. There must be at least two pins or wires connected to each ring, and typically there will be at least three pins or wires. Any FDA approved ring fixator meeting this definition from any manufacturer is allowed.
Definitive fixation with a locked IM nail or plate
Eligible patients with tibial diaphyseal fractures will typically receive a standard locked IM Nail. The nail must use at least one static interlock proximal to and one static interlock distal to the fracture site. The nail may be placed with either a reamed or unreamed technique. Methaphyseal fractures, especially those with fracture lines extending into the joint may be more commonly treated with plate fixation. The plate may be applied in an open or percutaneous fashion. Any combination of locked and/or non-locked screws may be used.
Locations (33)
University of Alabama at Birmingham
Birmingham, Alabama, United States
Naval Medical Center San Diego
San Diego, California, United States
UCSF Medical Center
San Francisco, California, United States
Denver Health and Hospital Authority
Denver, Colorado, United States
University of Miami Ryder Trauma Center
Miami, Florida, United States
Orlando Regional Medical Center
Orlando, Florida, United States
Florida Orthopaedic Institute, Tampa General Hospital
Tampa, Florida, United States
Eskenazi Health
Indianapolis, Indiana, United States
OrthoIndy / Methodist Hospital
Indianapolis, Indiana, United States
St Vincent Hospital
Indianapolis, Indiana, United States
University of Maryland, R Adams Cowley Shock Trauma Center
Baltimore, Maryland, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, United States
Boston Medical Center
Boston, Massachusetts, United States
Hennepin County Medical Center / Minneapolis
Minneapolis, Minnesota, United States
Regions Hospital
Saint Paul, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
St. Louis Medical Center
St Louis, Missouri, United States
Mission Hospital
Asheville, North Carolina, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
Geisinger Health System
Danville, Pennsylvania, United States
Penn State University M.S. Hershey Medical Center
Hershey, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Texas Tech University Health Sciences Center
El Paso, Texas, United States
San Antonio Military Medical Center
Fort Sam Houston, Texas, United States
UT Health: The University of Texas Health Science Center at Houston Medical School
Houston, Texas, United States
University of Texas Health Science Center, San Antonio
San Antonio, Texas, United States
Naval Medical Center Portsmouth
Portsmouth, Virginia, United States
University of Wisconsin
Madison, Wisconsin, United States