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COMPLETED
NCT01494519
PHASE3

Assessment of Fixation Strategies for Severe Open Tibia Fractures

Sponsor: Major Extremity Trauma Research Consortium

View on ClinicalTrials.gov

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

PROCEDURE

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.

PROCEDURE

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