Assessment of Fixation Strategies for Severe Open Tibia Fractures

PHASE3CompletedINTERVENTIONAL
Enrollment

442

Participants

Timeline

Start Date

July 31, 2011

Primary Completion Date

September 30, 2017

Study Completion Date

September 30, 2018

Conditions
Severe Open Fractures of the Tibia (Shin) Bone
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."

Trial Locations (33)

15212

Allegheny General Hospital, Pittsburgh

15213

University of Pittsburgh, Pittsburgh

17033

Penn State University M.S. Hershey Medical Center, Hershey

17822

Geisinger Health System, Danville

20889

Walter Reed National Military Medical Center, Bethesda

21201

University of Maryland, R Adams Cowley Shock Trauma Center, Baltimore

23708

Naval Medical Center Portsmouth, Portsmouth

28232

Carolinas Medical Center, Charlotte

28801

Mission Hospital, Asheville

32806

Orlando Regional Medical Center, Orlando

33101

University of Miami Ryder Trauma Center, Miami

33606

Florida Orthopaedic Institute, Tampa General Hospital, Tampa

35294

University of Alabama at Birmingham, Birmingham

37232

Vanderbilt University Medical Center, Nashville

39216

University of Mississippi Medical Center, Jackson

44109

MetroHealth Medical Center, Cleveland

46202

Eskenazi Health, Indianapolis

OrthoIndy / Methodist Hospital, Indianapolis

46260

St Vincent Hospital, Indianapolis

53705

University of Wisconsin, Madison

55101

Regions Hospital, Saint Paul

55415

Hennepin County Medical Center / Minneapolis, Minneapolis

63110

St. Louis Medical Center, St Louis

75390

University of Texas Southwestern Medical Center, Dallas

77030

UT Health: The University of Texas Health Science Center at Houston Medical School, Houston

78229

University of Texas Health Science Center, San Antonio, San Antonio

79905

Texas Tech University Health Sciences Center, El Paso

80204

Denver Health and Hospital Authority, Denver

92134

Naval Medical Center San Diego, San Diego

94115

UCSF Medical Center, San Francisco

02118

Boston Medical Center, Boston

27157-1070

Wake Forest University Baptist Medical Center, Winston-Salem

78234-6315

San Antonio Military Medical Center, Fort Sam Houston

All Listed Sponsors
collaborator

United States Department of Defense

FED

lead

Major Extremity Trauma Research Consortium

OTHER

NCT01494519 - Assessment of Fixation Strategies for Severe Open Tibia Fractures | Biotech Hunter | Biotech Hunter