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Battle of the amputations: which below-knee surgery gives better results?

NCT ID NCT01821976

Disease control Sponsor: Major Extremity Trauma Research Consortium Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compared two common below-knee amputation procedures: the Ertl (which creates a bone bridge between the shin and calf bones) and the Burgess (which does not). Researchers wanted to see which leads to better function, less pain, and fewer follow-up surgeries. A total of 199 people who needed a below-knee amputation after a severe leg injury took part. The results could help surgeons choose the best technique for future patients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ertl procedure (tibia-fibula bone bridge) vs Burgess procedure (no bone bridge)
What this could lead to
If one procedure proves clearly better, it could become the standard for below-knee amputations, improving mobility and reducing pain for future patients.
What could go wrong
This is a completed study, so results are already known. The advantage of one procedure over the other may be small or not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

199 people

The number who actually took part.

Start date

Mar 2013

Finished

Mar 2020

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Transtibial amputation

Contacts and locations

Locations

  • Barnes Jewish Hospital

    St Louis, Missouri, 63110, United States

  • Carolinas Medical Center

    Charlotte, North Carolina, 28232, United States

  • Emory University School of Medicine

    Atlanta, Georgia, 30303, United States

  • Eskenazi Health

    Indianapolis, Indiana, 46202, United States

  • Florida Orthopaedic Institute- Tampa General Hospital

    Tampa, Florida, 33606, United States

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55430, United States

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109, United States

  • Penn State University M.S. Hershey Medical Center

    Hershey, Pennsylvania, 17033, United States

  • Rhode Island Hospital, Brown University

    Providence, Rhode Island, 02903, United States

  • San Antonio Miliary Medical Center

    Fort Sam Houston, Texas, 78234-6315, United States

  • St. Louis University Medical Center

    St Louis, Missouri, 63110, United States

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

    Houston, Texas, 77030, United States

  • University of California San Francisco Medical Center

    San Francisco, California, 94143, United States

  • University of Iowa Hospitals & Clinics

    Iowa City, Iowa, 52242, United States

  • University of Maryland/R Adams Cowley Shock Trauma Medical Center

    Baltimore, Maryland, 212101, United States

  • University of Miami Ryder Trauma Center

    Miami, Florida, 33136, United States

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216, United States

  • University of Oklahoma

    Oklahoma City, Oklahoma, 73104, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15219, United States

  • University of Wisconsin School of Medicine and Public Health

    Madison, Wisconsin, 53726, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

  • Wake Forest University Baptist Medical Center

    Winston-Salem, North Carolina, 27157, United States

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20889, United States

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