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

Completed

Conditions studied: Severe Distal Tibia Injury, Severe Ankle Injury, Severe Foot Injury, Major Soft Tissue Loss, Major Bone Articular Surface Loss, Major Ankle Articular Surface Loss

In brief

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).

Key facts

Study ID: NCT01606501
Run by: Major Extremity Trauma Research Consortium
People needed: 664
Starts: 2012-05-01
Expected to finish: 2019-09-20
Last updated by the study team: 2021-03-24

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.
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:
ankle dislocation (80A)
subtalar dislocation (80B)
extruded talus
chopart dislocation (80C)
multiple midfoot dislocations (80C)
three or greater proximal metatarsal fractures
heel pad/plantar degloving
extensive muscle necrosis in an open injury from crush, ischemia and/or foot compartment syndrome
These injuries may include "toe-pan" injuries from motor vehicle accidents and crush-like injuries from motorcycle accidents, and traumatic amputations.

You may not qualify if…

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
Follow-up is planned at another medical center
Patients who are prisoners or homeless

Where it is running

University of Alabama at Birmingham — Birmingham, Alabama, United States
Navy Medical Center San Diego — San Diego, California, United States
University of California San Francisco Medical Center — San Francisco, California, United States
Denver Health and Hospital Authority — Denver, Colorado, United States
Walter Reed National Military Medical Center — Washington D.C., District of Columbia, United States
University of Miami Ryder Trauma Center — Miami, Florida, United States
Orlando Regional Medical Center — Orlando, Florida, United States
Florida Orthopaedic Institute, St. Joseph's Hospital — Tampa, Florida, United States
Florida Orthopaedic Institute, Tampa General Hospital — Tampa, Florida, United States
Eskenazi Health — Indianapolis, Indiana, United States
OrthoIndy Methodist Hospital — Indianapolis, Indiana, United States
St. Vincent Indianapolis Hospital — Indianapolis, Indiana, United States
University of Iowa Medical Center — Iowa City, Iowa, United States
University of Maryland Medical Center — Baltimore, Maryland, United States
Orthopaedic Associates of Michigan — Grand Rapids, Michigan, United States
Hennepin County Medical Center — Minneapolis, Minnesota, United States
University of Mississippi Medical Center — Jackson, Mississippi, United States
Barnes Jewish Hospital — St Louis, Missouri, United States
St. Louis University Medical Center — St Louis, Missouri, United States
Jamaica Hospital Medical Center — Jamaica, New York, United States
Carolinas Medical Center — Charlotte, North Carolina, United States
Duke University Medical Center — Durham, North Carolina, United States
Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, United States
MetroHealth — Cleveland, Ohio, United States
Oklahoma University Medical Center — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.