Outcomes Following Severe Distal Tibia, Ankle and/or Foot Trauma: Comparison of Limb Salvage Versus Transtibial Amputation Protocol
NCT ID: NCT01606501
Last Updated: 2021-03-24
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
664 participants
OBSERVATIONAL
2012-05-31
2019-09-20
Brief Summary
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Hypothesis 1: As a group, salvage patients with severe distal tibia, ankle and/or foot injuries with major soft tissue, bone and/or ankle articular surface loss will have similar functional outcomes and HRQoL had they undergone a transtibial amputation (within 6 weeks of injury).
Hypothesis 2: The subgroup of salvage patients who have either (1) a soft tissue injury that requires tissue transfer; (2) articular damage requiring arthrodesis of the ankle joint; or (3) bone loss at the distal tibia or ankle will have better functional outcomes and HRQoL had they undergone a transtibial amputation (within 6 weeks of injury).
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Limb Salvage patients
Patients undergoing limb salvage following severe distal tibia, ankle and/or foot injuries with major soft tissue, bone and/or ankle articular surface loss.
No interventions assigned to this group
Transtibial Amputation patients
Patients undergoing transtibial amputation following severe distal tibia, ankle and/or foot injuries with major soft tissue, bone and/or ankle articular surface loss.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
1. Gustilo type III pilon fractures consistent with one of the following OTA codes: 43B1.3, 43B2-B3, 43C, 44B, 44C
2. Gustilo type III B or C ankle fractures
3. Gustilo type III mid and/or hind foot fractures consistent with one of the following OTA codes: 81B2-B3, 82B and 82C
4. Open foot crush or blast injuries from high energy mechanism involving the mid and /or hind foot with significant soft tissues damage
5. Other severe foot injury (including closed foot crush or blast injuries)
2. Ages 18-60 inclusive.
3. Admitted to the hospital prior to definitive wound closure.
Inclusion notes:
Exclusion Criteria
1. ankle dislocation (80A)
2. subtalar dislocation (80B)
3. extruded talus
4. chopart dislocation (80C)
5. multiple midfoot dislocations (80C)
6. three or greater proximal metatarsal fractures
7. heel pad/plantar degloving
8. extensive muscle necrosis in an open injury from crush, ischemia and/or foot compartment syndrome
3. These injuries may include "toe-pan" injuries from motor vehicle accidents and crush-like injuries from motorcycle accidents, and traumatic amputations.
1. Patient has a Glasgow Coma Scale motor score of 0-4 or a Glasgow Coma Scale motor score of 5 with a significant traumatic brain injury (defined as an AIS code of 5 or 6) at time of consent
2. Patient has third degree burns on \>10% total surface area affecting the study limb
3. Patient has a previous leg or foot amputation of either limb
4. Patient is non-ambulatory due to an associated complete spinal cord injury
5. Patient non-ambulatory pre-injury
6. Patient speaks neither English nor Spanish
7. Patient likely to have severe problems with maintaining follow- up due to at least one of the following:
1. Patient has been diagnosed with a severe psychiatric condition
2. Patient is intellectually challenged without adequate family support
3. Patient lives outside the hospital's catchment area
4. Follow-up is planned at another medical center
5. Patients who are prisoners or homeless
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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Michael J Bosse, MD
Role: PRINCIPAL_INVESTIGATOR
Carolinas Medical Center
Lisa Reider, MHS, PhD
Role: STUDY_DIRECTOR
Johns Hopkins Bloomberg School of Public Health
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Navy Medical Center San Diego
San Diego, California, United States
University of California San Francisco Medical Center
San Francisco, California, United States
Denver Health and Hospital Authority
Denver, Colorado, United States
Walter Reed National Military Medical Center
Washington D.C., District of Columbia, United States
University of Miami Ryder Trauma Center
Miami, Florida, United States
Orlando Regional Medical Center
Orlando, Florida, United States
Florida Orthopaedic Institute, St. Joseph's Hospital
Tampa, Florida, United States
Florida Orthopaedic Institute, Tampa General Hospital
Tampa, Florida, United States
Eskenazi Health
Indianapolis, Indiana, United States
OrthoIndy Methodist Hospital
Indianapolis, Indiana, United States
St. Vincent Indianapolis Hospital
Indianapolis, Indiana, United States
University of Iowa Medical Center
Iowa City, Iowa, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Orthopaedic Associates of Michigan
Grand Rapids, Michigan, 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
Jamaica Hospital Medical Center
Jamaica, New York, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
MetroHealth
Cleveland, Ohio, United States
Oklahoma University Medical Center
Oklahoma City, Oklahoma, United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Rhode Island/ Brown University
Providence, Rhode Island, United States
Vanderbilt Medical Center
Nashville, Tennessee, United States
University of Texas Health Science Center at Houston
Houston, Texas, United States
San Antonio Military Medical Center
San Antonio, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
University of Washington/Harborview Medical Center
Seattle, Washington, United States
Countries
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References
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McLaughlin KH, Mitchell SL, Archer KR, Master H, Morshed S, Gary JL, Jones CB, MacKenzie EJ, Reider L; METRC. Effect of Severe Distal Tibia, Ankle, and Mid- to Hindfoot Trauma on Meeting Physical Activity Guidelines 18 Months After Injury. Arch Phys Med Rehabil. 2022 Mar;103(3):409-417.e2. doi: 10.1016/j.apmr.2021.07.805. Epub 2021 Aug 21.
Other Identifiers
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W81XWH-09-2-0108-OUT
Identifier Type: -
Identifier Source: org_study_id
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