Outcomes Following Severe Distal Tibia, Ankle and/or Foot Trauma: Comparison of Limb Salvage Versus Transtibial Amputation Protocol (OUTLET Study)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Severe Distal Tibia Injury
- Sponsor
- Major Extremity Trauma Research Consortium
- Enrollment
- 664
- Locations
- 33
- Primary Endpoint
- Patient reported function and health related quality of life
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with an injury that meets at least one of the following:
- •Gustilo type III pilon fractures consistent with one of the following OTA codes: 43B1.3, 43B2-B3, 43C, 44B, 44C
- •Gustilo type III B or C ankle fractures
- •Gustilo type III mid and/or hind foot fractures consistent with one of the following OTA codes: 81B2-B3, 82B and 82C
- •Open foot crush or blast injuries from high energy mechanism involving the mid and /or hind foot with significant soft tissues damage
- •Other severe foot injury (including closed foot crush or blast injuries)
- •Ages 18-60 inclusive.
- •Admitted to the hospital prior to definitive wound closure.
- •Inclusion notes:
- •Patients may have other injuries except as noted below under exclusion criteria.
Exclusion Criteria
- •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
- •Patient has third degree burns on \>10% total surface area affecting the study limb
- •Patient has a previous leg or foot amputation of either limb
- •Patient is non-ambulatory due to an associated complete spinal cord injury
- •Patient non-ambulatory pre-injury
- •Patient speaks neither English nor Spanish
- •Patient likely to have severe problems with maintaining follow- up due to at least one of the following:
- •Patient has been diagnosed with a severe psychiatric condition
- •Patient is intellectually challenged without adequate family support
- •Patient lives outside the hospital's catchment area
Outcomes
Primary Outcomes
Patient reported function and health related quality of life
Time Frame: 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 Outcomes
- Physical impairment(18 months)
- Levels of participation(18 months)