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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Major Extremity Trauma Research Consortium
Sponsor:
Information provided by (Responsible Party):
Major Extremity Trauma Research Consortium
ClinicalTrials.gov Identifier:
NCT01606501
First received: April 16, 2012
Last updated: November 19, 2014
Last verified: November 2014
  Purpose

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
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
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Major Extremity Trauma Research Consortium:

Primary Outcome Measures:
  • Patient reported function and health related quality of life [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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:
  • Physical impairment [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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.

  • Levels of participation [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 464
Study Start Date: May 2012
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01606501

Contacts
Contact: Michael J Bosse, MD 704-355-6046 michael.bosse@carolinashealthcare.org
Contact: Ellen MacKenzie, PhD 410-614-4025 emacken1@jhu.edu

  Show 40 Study Locations
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
  More Information

No publications provided

Responsible Party: Major Extremity Trauma Research Consortium
ClinicalTrials.gov Identifier: NCT01606501     History of Changes
Other Study ID Numbers: W81XWH-09-2-0108-OUT
Study First Received: April 16, 2012
Last Updated: November 19, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Additional relevant MeSH terms:
Ankle Injuries
Foot Injuries
Leg Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on November 23, 2014