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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 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 26, 2012
Last verified: November 2012
  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 arthodesis 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 activty (work, active duty, school, home management) and the Paffenbarger Activty 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: June 2015
Estimated Primary Completion Date: June 2015 (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:

  • Patients with either (1) Gustilo type III B distal tibia and foot or type III B or C ankle fractures with fracture pattern consistent with one of OTA codes: 43B1.3, 43B2-B3, 43C, 44B, 44C, 81B2-B3, 82B and 82C; (2) open or closed industrial foot crush injuries; of (3) open or closed foot blast injuries.
  • Ages 18-60 inclusive.
  • Admitted to the hospital prior to definitive wound closure.
  • Patients may have other injuries except as noted below under exclusion criteria.

Exclusion Criteria:

  • Patient has a Glasgow Coma Scale score <15 at 21 days post injury or at the time of discharge (if sooner)
  • Patient is non-ambulatory due to an associated complete spinal cord injury
  • Patient has a previous leg or foot amputation or are non-ambulatory pre-injury
  • Patient has third degree burns on >10% total surface area affecting the study limb
  • Patient speaks neither English nor Spanish
  • Patient has been diagnosed with a severe psychiatric condition
  • Patient lives outside the hospital's catchment area and/or follow-up is planned at another medical center
  • Severe problems with maintaining follow-up (e.g., patients who are prisoners or homeless at the time of injury or those who are intellectually challenged without adequate family support)
  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: Rachel Seymour, PhD 704-355-6969 Rachel.Seymour@carolinashealthcare.org

  Show 34 Study Locations
Sponsors and Collaborators
Major Extremity Trauma Research Consortium
Investigators
Principal Investigator: Michael J Bossee, MD Carolinas Medical Center
Study Director: Ellen J MacKenzie, 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 26, 2012
Health Authority: United States: Institutional Review Board
United States: Federal Government

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

ClinicalTrials.gov processed this record on August 18, 2014