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COMPLETED
NCT01821976
NA

Transtibial Amputation Outcomes Study

Sponsor: Major Extremity Trauma Research Consortium

View on ClinicalTrials.gov

Summary

The goals of the TAOS study is to determine the best procedures for below the knee amputations. There are two different procedures currently used by surgeons around the county: the Erlt procedure and the Burgess procedure. Proponents of the Ertl procedure advocate that the surgical formation of a tibia to fibula bone bridge provides stability, shape and weight bearing capability to the residual limb that result in less pain and better prosthetic fit and alignment. This procedure is popular especially among the military but it's advantages over the Burgess procedure are not well supported by current research. This study aims to compare the two amputation procedures in an adequately powered randomized trial.

Official title: Transtibial Amputation Outcomes Study (TAOS): Comparing Transtibial Amputation With (Ertl) and Without a Tibia-fibula Synostosis Procedure

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

199

Start Date

2013-03

Completion Date

2020-03

Last Updated

2026-05-26

Healthy Volunteers

No

Interventions

PROCEDURE

Ertl Procedure

PROCEDURE

Burgess Procedure

Locations (23)

University of California San Francisco Medical Center

San Francisco, California, United States

University of Miami Ryder Trauma Center

Miami, Florida, United States

Florida Orthopaedic Institute- Tampa General Hospital

Tampa, Florida, United States

Emory University School of Medicine

Atlanta, Georgia, United States

Eskenazi Health

Indianapolis, Indiana, United States

University of Iowa Hospitals & Clinics

Iowa City, Iowa, United States

University of Maryland/R Adams Cowley Shock Trauma Medical Center

Baltimore, Maryland, United States

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Hennepin County Medical Center

Minneapolis, Minnesota, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

Barnes Jewish Hospital

St Louis, Missouri, United States

St. Louis University Medical Center

St Louis, Missouri, 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

University of Oklahoma

Oklahoma City, Oklahoma, United States

Penn State University M.S. Hershey Medical Center

Hershey, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Rhode Island Hospital, Brown University

Providence, Rhode Island, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

San Antonio Miliary 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 Wisconsin School of Medicine and Public Health

Madison, Wisconsin, United States