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Summary

for people ages 18–60 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

The primary aim this prospective longitudinal observational outcomes study is to compare 18 month functional outcomes and health related quality of life (HRQoL) of patients undergoing salvage versus amputation following severe distal tibia, ankle and/or foot fractures with major soft tissue, bone and/or ankle articular surface loss. Functional outcomes and HRQoL will be measured using well established self reported measures, including the Veterans Rand Health Survey (VR-12) and the Short Musculoskeletal Functional Assessment (SMFA). 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).

Official Title

Outcomes Following Severe Distal Tibia, Ankle and/or Foot Trauma: Comparison of Limb Salvage Versus Transtibial Amputation Protocol (OUTLET Study)

Keywords

Severe Distal Tibia Injury Severe Ankle Injury Severe Foot Injury Major Soft Tissue Loss Major Bone Articular Surface Loss Major Ankle Articular Surface Loss Wounds and Injuries Ankle Injuries Foot Injuries

Eligibility

You can join if…

Open to people ages 18–60

  1. Patients with an injury that meets at least one of the following:
  2. Gustilo type III pilon fractures consistent with one of the following OTA codes:43B1.3, 43B2-B3, 43C, 44B, 44C
  3. Gustilo type III B or C ankle fractures
  4. Gustilo type III mid and/or hind foot fractures consistent with one of the following OTA codes: 81B2-B3, 82B and 82C
  5. Open foot crush or blast injuries from high energy mechanism involving the mid and /or hind foot with significant soft tissues damage
  6. Other severe foot injury (including closed foot crush or blast injuries)
  7. Ages 18-60 inclusive.
  8. Admitted to the hospital prior to definitive wound closure.

Inclusion notes:

  1. Patients may have other injuries except as noted below under

You CAN'T join if...

.

  1. Foot crush and blast injuries are eligible if they are considered to be at significant risk for impaired outcome with moderate to severe disability and typically include one of the following associated injuries:
  2. ankle dislocation (80A)
  3. subtalar dislocation (80B)
  4. extruded talus
  5. chopart dislocation (80C)
  6. multiple midfoot dislocations (80C)
  7. three or greater proximal metatarsal fractures
  8. heel pad/plantar degloving
  9. extensive muscle necrosis in an open injury from crush, ischemia and/or foot compartment syndrome
  10. These injuries may include "toe-pan" injuries from motor vehicle accidents and crush-like injuries from motorcycle accidents, and traumatic amputations.

Exclusion Criteria:

  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:
  8. Patient has been diagnosed with a severe psychiatric condition
  9. Patient is intellectually challenged without adequate family support
  10. Patient lives outside the hospital's catchment area
  11. Follow-up is planned at another medical center
  12. Patients who are prisoners or homeless

Locations

  • University of California San Francisco Medical Center
    San Francisco, California, 94143, United States
  • Navy Medical Center San Diego
    San Diego, California, 92134, United States
  • University of Washington/Harborview Medical Center
    Seattle, Washington, 98104, United States
  • Denver Health and Hospital Authority
    Denver, Colorado, 80204, United States
  • Texas Tech University Health Science Center
    El Paso, Texas, 79905, United States
  • Oklahoma University Medical Center
    Oklahoma City, Oklahoma, 73104, United States
  • University of Texas Health Science Center at Houston
    Houston, Texas, 77030, United States
  • Hennepin County Medical Center
    Minneapolis, Minnesota, 55430, United States
  • Barnes Jewish Hospital
    Saint Louis, Missouri, 63110, United States
  • St. Louis University Medical Center
    Saint Louis, Missouri, 63110, United States
  • University of Mississippi Medical Center
    Jackson, Mississippi, 39216, United States
  • Vanderbilt Medical Center
    Nashville, Tennessee, 37232, United States
  • Eskenazi Health
    Indianapolis, Indiana, 46202, United States
  • OrthoIndy Methodist Hospital
    Indianapolis, Indiana, 46202, United States
  • University of Alabama at Birmingham
    Birmingham, Alabama, 35294, United States
  • MetroHealth
    Cleveland, Ohio, 44109, United States
  • University of Pittsburgh Medical Center
    Pittsburgh, Pennsylvania, 15213, United States
  • Carolinas Medical Center
    Charlotte, North Carolina, 28203, United States
  • Wake Forest Baptist Medical Center
    Winston-Salem, North Carolina, 27103, United States
  • Florida Orthopaedic Institute, St. Joseph's Hospital
    Tampa, Florida, 33606, United States
  • Florida Orthopaedic Institute, Tampa General Hospital
    Tampa, Florida, 33606, United States
  • University of Virginia
    Charlottesville, Virginia, 22908, United States
  • Duke University Medical Center
    Durham, North Carolina, 27710, United States
  • Orlando Regional Medical Center
    Orlando, Florida, 32806, United States
  • Walter Reed National Military Medical Center
    Washington, D.C., District of Columbia, 20307, United States
  • University of Maryland Medical Center
    Baltimore, Maryland, 21201, United States
  • University of Miami Ryder Trauma Center
    Miami, Florida, 33136, United States
  • Jamaica Hospital Medical Center
    Jamaica, New York, 11418, United States
  • Rhode Island/ Brown University
    Providence, Rhode Island, 02905, United States
  • San Antonio Military Medical Center
    San Antonio, Texas, 78434, United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Major Extremity Trauma Research Consortium
ID
NCT01606501
Study Type
Observational
Last Updated
June 12, 2017