Completed

TAOSComparing Transtibial Amputation Techniques: Ertl vs. Burgess Procedures

Study Aim

This study compares the Ertl and Burgess procedures for transtibial amputation, focusing on patient-reported function using the Short Form Musculoskeletal Assessment 18 months after the surgery, and the number of revision surgeries required within the same period.

What is being tested

Ertl Procedure

+ Burgess Procedure

Procedure

Who is being recruted

From 18 to 60 Years

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: March 2013

See protocol details

Summary

Principal SponsorMajor Extremity Trauma Research Consortium

Last updated: May 26, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2013

Actual date on which the first participant was enrolled.

High-energy open fractures, blast, gunshot wound and crush injuries to the distal tibia, ankle, hind foot and midfoot are common challenges to military and civilian trauma surgeons (Brown, 2009; Covey, 2002; Ficke, 2007; McGuigan, 2007; Hansen, 2001). Many surgeons believe that an early transtibial amputation provides a better long term functional outcome than limb salvage for these injuries (Hansen, 2001; Myerson, 1994; Sanders, 1992; Turchin,1999; Shawen, 2010;Ellington 2012). If a transtibial amputation is selected as the treatment for the patient, a controversy remains regarding the appropriate amputation technique. Many surgeons advocate for an amputation with a tibia-fibula synostosis technique (Ertl procedure) in young and active patients, believing that this procedure provides a better prosthetic interface, an end bearing capacity and soft tissue stability that improves performance and functional outcomes. (Pinto 2004; Pinzur 2006; Commuri 2010). Others strongly advocate for a standard posterior flap (Burgess procedure) without the synostosis, arguing that patients have similar outcomes with fewer complications and lower costs. (Pinzur 2008; Tindle 2011) To date, the outcomes of the transtibial amputation techniques have not been subjected to an appropriately powered prospective randomized clinical trial. The primary study objective is to compare functional outcomes and number of revision surgeries to the amputated limb after first amputation for patients undergoing a transtibial amputation and randomized to receive a tibia-fibula synostosis (Ertl procedure) versus a standard posterior flap procedure (Burgess procedure). The secondary study objectives are to compare levels of impairment for patients undergoing a transtibial amputation and randomized to receive a tibia-fibula synostosis (Ertl procedure) versus a standard posterior flap procedure (Burgess procedure); to compare levels of pain for patients undergoing a transtibial amputation and randomized to receive a tibia-fibula synostosis (Ertl procedure) versus a standard posterior flap procedure (Burgess procedure); and to compare initial hospitalization and overall treatment costs (through the 18 month follow-up) for patients undergoing a transtibial amputation and are randomized to receive a tibia-fibula synostosis (Ertl procedure) versus a standard posterior flap procedure (Burgess procedure). Patients who refuse randomization have the option of participating in a prospective observational study and the type of amputation is decided by the surgeon and patient.

NCT01821976

Principal SponsorMajor Extremity Trauma Research Consortium

Last updated: May 26, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

199 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Active Comparator

Patients randomized to the Ertl Procedure Arm will receive an amputation very similar to the Burgess Procedure, except the surgeon will perform an additional step to make the cut end of the tibia bone heal to the cut end of the fibula bone with a bone bridge. This bone bridge connects the two bones together.

Group II

Active Comparator

Patients randomized to the Burgess Procedure Arm will receive a below the knee amputation where the bone is cut and skin and muscle from the back of the leg are rotated to cover the cut end of your bone. This provides good soft tissue padding to the bone and a good shape to the leg for later fitting of your prosthesis.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 23 locations

University of California San Francisco Medical Center

San Francisco, United StatesOpen University of California San Francisco Medical Center in Google Maps

University of Miami Ryder Trauma Center

Miami, United States

Florida Orthopaedic Institute- Tampa General Hospital

Tampa, United States

Emory University School of Medicine

Atlanta, United States

Completed23 Study Centers