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

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

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).

Study Overview

• Status: Completed
• Conditions: Severe Distal Tibia Injury; Severe Ankle Injury; Severe Foot Injury; Major Soft Tissue Loss; Major Bone Articular Surface Loss; Major Ankle Articular Surface Loss

• Study Type: Observational
• Enrollment (Actual): 664

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
  • California
    • San Diego, California, United States, 92134
      • Navy Medical Center San Diego
    • San Francisco, California, United States, 94143
      • University of California San Francisco Medical Center
  • Colorado
    • Denver, Colorado, United States, 80204
      • Denver Health and Hospital Authority
  • District of Columbia
    • Washington, District of Columbia, United States, 20307
      • Walter Reed National Military Medical Center
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami Ryder Trauma Center
    • Orlando, Florida, United States, 32806
      • Orlando Regional Medical Center
    • Tampa, Florida, United States, 33606
      • Florida Orthopaedic Institute, Tampa General Hospital
    • Tampa, Florida, United States, 33606
      • Florida Orthopaedic Institute, St. Joseph's Hospital
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • St. Vincent Indianapolis Hospital
    • Indianapolis, Indiana, United States, 46202
      • Eskenazi Health
    • Indianapolis, Indiana, United States, 46202
      • OrthoIndy Methodist Hospital
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Medical Center
  • Michigan
    • Grand Rapids, Michigan, United States, 49525
      • Orthopaedic Associates of Michigan
  • Minnesota
    • Minneapolis, Minnesota, United States, 55430
      • Hennepin County Medical Center
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi Medical Center
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Barnes Jewish Hospital
    • Saint Louis, Missouri, United States, 63110
      • St. Louis University Medical Center
  • New York
    • Jamaica, New York, United States, 11418
      • Jamaica Hospital Medical Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Carolinas Medical Center
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
    • Winston-Salem, North Carolina, United States, 27103
      • Wake Forest Baptist Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44109
      • MetroHealth
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Oklahoma University Medical Center
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Hershey Medical Center
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
  • Rhode Island
    • Providence, Rhode Island, United States, 02905
      • Rhode Island/ Brown University
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt Medical Center
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas Health Science Center at Houston
    • San Antonio, Texas, United States, 78434
      • San Antonio Military Medical Center
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia
  • Washington
    • Seattle, Washington, United States, 98104
      • University of Washington/Harborview Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study population will be patients aged 18-60 with severe open or crushed distal tibia, ankle and/or foot injury that go on to limb salvage or receive a below the knee amputation.

Description

Inclusion Criteria:

1. Patients with an injury that meets at least one of the following:

   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:

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:

   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.

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:

   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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient reported function and health related quality of life	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).	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical impairment	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.	18 months
Levels of participation	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.	18 months

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): September 20, 2019
• Study Completion (Actual): September 20, 2019

Study Registration Dates

• First Submitted: April 16, 2012
• First Submitted That Met QC Criteria: May 23, 2012
• First Posted (Estimate): May 25, 2012

Study Record Updates

• Last Update Posted (Actual): March 24, 2021
• Last Update Submitted That Met QC Criteria: March 23, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Leg Injuries; Wounds and Injuries; Ankle Injuries; Foot Injuries
• Other Study ID Numbers: W81XWH-09-2-0108-OUT