Transtibial Amputation Outcomes Study

Completed · Not applicable

Conditions studied: Transtibial Amputation

In brief

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.

Key facts

Study ID

NCT01821976

Run by

Major Extremity Trauma Research Consortium

People needed

199

Starts

2013-03-01

Expected to finish

2020-03-01

Last updated by the study team

2026-05-26

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients requiring a unilateral transtibial amputation following major limb trauma regardless of when the injury occurred
• The injury and its treatment must meet the following criteria:
• The residual fibula is not fractured or if fractured, is stabilized by internal fixation allowing for either the Ertl or Burgess procedure
• Proximal tibia/fibula joint is stabilized
• Soft tissue coverage allows for atypical closure and skin graft <100 cm2
• Amputation will result in a residual limb that is ≥10 cm from joint line to end of tibia
• Ages 18 and 60 inclusive

You may not qualify if…

• At time of consent, patient has a Glasgow Coma Scale (GCS) motor score of 0-4 or a GCS motor score of 5 with a significant traumatic brain injury (defined as an AIS code of 5 or 6)
• Patients with wound closure requiring a free tissue transfer
• Fibula fractures proximal to the tibial bone cut that cannot be stabilized
• Late amputation with presence of one of the following conditions: (i) infection within the zone of injury; (ii) chronic regional pain syndrome; (iii) post-traumatic thrombophlebitis
• Patient has a spinal cord deficit
• Patient has a previous leg or foot amputation or is non-ambulatory pre-injury
• Patient has third degree burns on >10% total surface area affecting the study limb
• Patient has a documented psychiatric disorder
• Patient is unable to speak either English or Spanish
• Severe problems with maintaining follow-up (e.g. patients who are prisoners or homeless at the time of injury or who are intellectually challenged without adequate family support).
• Patient has an amputation to one or both upper extremities (excluding digits)
• Patient is outside hospital's catchment area
• Patient follow-up is planned at another medical center

Where it is running

• 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

Full record on ClinicalTrials.gov

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