Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
250 participants
INTERVENTIONAL
2013-03-31
2020-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ertl Procedure
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.
Ertl Procedure
Burgess Procedure
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.
Burgess Procedure
Interventions
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Ertl Procedure
Burgess Procedure
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
ALL
No
Sponsors
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Major Extremity Trauma Research Consortium
OTHER
Responsible Party
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Principal Investigators
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Lisa Reider, MHS, PhD
Role: STUDY_DIRECTOR
Johns Hopkins University
Locations
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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
Countries
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Other Identifiers
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W8XWH-10-2-0090
Identifier Type: -
Identifier Source: org_study_id