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

Sponsor
Major Extremity Trauma Research Consortium (Other)
Overall Status
Completed
CT.gov ID
NCT01606501
Collaborator
(none)
664
Enrollment
33
Locations
88.6
Duration (Months)
20.1
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    664 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Outcomes Following Severe Distal Tibia, Ankle and/or Foot Trauma: Comparison of Limb Salvage Versus Transtibial Amputation Protocol (OUTLET Study)
    Study Start Date :
    May 1, 2012
    Actual Primary Completion Date :
    Sep 20, 2019
    Actual Study Completion Date :
    Sep 20, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    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.
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Patient reported function and health related quality of life [18 months]

      Functional Outcomes and health related quality of life will be measured using well established self reported measures, including the Veterans RAND Health Survey (VR-12) and the Short Musculoskeletal Functional Assessment (SMFA).

    Secondary Outcome Measures

    1. Physical impairment [18 months]

      Physical impairment will be determined using objective performance measures of agility (4 step square test and Illinois Agility Test), strength and power (sit-to-stand test and timed stair climb), speed (self-selected walking speed and 40 yard shuttle run), postural stability (single leg stance) and overall activity will be measured using the step watch activity monitor.

    2. Levels of participation [18 months]

      Levels of participation will be measured using self reported measures of return to usual major activity (work, active duty, school, home management) and the Paffenbarger Activity Scale (PPAQ) that measures participation in light, moderate and vigorous recreational or sports activities.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    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 exclusion criteria.

    2. 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:

    3. ankle dislocation (80A)

    4. subtalar dislocation (80B)

    5. extruded talus

    6. chopart dislocation (80C)

    7. multiple midfoot dislocations (80C)

    8. three or greater proximal metatarsal fractures

    9. heel pad/plantar degloving

    10. extensive muscle necrosis in an open injury from crush, ischemia and/or foot compartment syndrome

    11. 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
    1. at time of consent

    1. Patient has third degree burns on >10% total surface area affecting the study limb

    2. Patient has a previous leg or foot amputation of either limb

    3. Patient is non-ambulatory due to an associated complete spinal cord injury

    4. Patient non-ambulatory pre-injury

    5. Patient speaks neither English nor Spanish

    6. Patient likely to have severe problems with maintaining follow- up due to at least one of the following:

    7. Patient has been diagnosed with a severe psychiatric condition

    8. Patient is intellectually challenged without adequate family support

    9. Patient lives outside the hospital's catchment area

    10. Follow-up is planned at another medical center

    11. Patients who are prisoners or homeless

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Birmingham Alabama United States 35294
    2 Navy Medical Center San Diego San Diego California United States 92134
    3 University of California San Francisco Medical Center San Francisco California United States 94143
    4 Denver Health and Hospital Authority Denver Colorado United States 80204
    5 Walter Reed National Military Medical Center Washington District of Columbia United States 20307
    6 University of Miami Ryder Trauma Center Miami Florida United States 33136
    7 Orlando Regional Medical Center Orlando Florida United States 32806
    8 Florida Orthopaedic Institute, St. Joseph's Hospital Tampa Florida United States 33606
    9 Florida Orthopaedic Institute, Tampa General Hospital Tampa Florida United States 33606
    10 Eskenazi Health Indianapolis Indiana United States 46202
    11 OrthoIndy Methodist Hospital Indianapolis Indiana United States 46202
    12 St. Vincent Indianapolis Hospital Indianapolis Indiana United States 46260
    13 University of Iowa Medical Center Iowa City Iowa United States 52242
    14 University of Maryland Medical Center Baltimore Maryland United States 21201
    15 Orthopaedic Associates of Michigan Grand Rapids Michigan United States 49525
    16 Hennepin County Medical Center Minneapolis Minnesota United States 55430
    17 University of Mississippi Medical Center Jackson Mississippi United States 39216
    18 Barnes Jewish Hospital Saint Louis Missouri United States 63110
    19 St. Louis University Medical Center Saint Louis Missouri United States 63110
    20 Jamaica Hospital Medical Center Jamaica New York United States 11418
    21 Carolinas Medical Center Charlotte North Carolina United States 28203
    22 Duke University Medical Center Durham North Carolina United States 27710
    23 Wake Forest Baptist Medical Center Winston-Salem North Carolina United States 27103
    24 MetroHealth Cleveland Ohio United States 44109
    25 Oklahoma University Medical Center Oklahoma City Oklahoma United States 73104
    26 Penn State Hershey Medical Center Hershey Pennsylvania United States 17033
    27 University of Pittsburgh Medical Center Pittsburgh Pennsylvania United States 15213
    28 Rhode Island/ Brown University Providence Rhode Island United States 02905
    29 Vanderbilt Medical Center Nashville Tennessee United States 37232
    30 University of Texas Health Science Center at Houston Houston Texas United States 77030
    31 San Antonio Military Medical Center San Antonio Texas United States 78434
    32 University of Virginia Charlottesville Virginia United States 22908
    33 University of Washington/Harborview Medical Center Seattle Washington United States 98104

    Sponsors and Collaborators

    • Major Extremity Trauma Research Consortium

    Investigators

    • Principal Investigator: Michael J Bosse, MD, Carolinas Medical Center
    • Study Director: Lisa Reider, MHS, PhD, Johns Hopkins Bloomberg School of Public Health

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Major Extremity Trauma Research Consortium
    ClinicalTrials.gov Identifier:
    NCT01606501
    Other Study ID Numbers:
    • W81XWH-09-2-0108-OUT
    First Posted:
    May 25, 2012
    Last Update Posted:
    Mar 24, 2021
    Last Verified:
    Mar 1, 2021
    Additional relevant MeSH terms:
    Wounds and Injuries
    Ankle Injuries
    Foot Injuries

    Study Results

    No Results Posted as of Mar 24, 2021