Clinical trial NCT01606501: Outcomes Following Severe Distal Tibia, Ankle and/or Foot Trauma: Comparison of Limb Salvage Versus Transtibial Amputation Protocol
Official title: Outcomes Following Severe Distal Tibia, Ankle and/or Foot Trauma: Comparison of Limb Salvage Versus Transtibial Amputation Protocol (OUTLET Study)
Study type: OBSERVATIONAL
Overall 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
Lead sponsor: Major Extremity Trauma Research Consortium
Sponsor class: OTHER
First posted: 2012-05-25
Enrollment: 664
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).


Eligibility 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

Primary outcomes:
measure: Patient reported function and health related quality of life
timeFrame: 18 months
Secondary outcomes:
measure: Physical impairment
timeFrame: 18 months
measure: Levels of participation
timeFrame: 18 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: San Diego
country: United States
facility: Navy Medical Center San Diego
state: California
city: San Francisco
country: United States
facility: University of California San Francisco Medical Center
state: California
city: Denver
country: United States
facility: Denver Health and Hospital Authority
state: Colorado
city: Washington
country: United States
facility: Walter Reed National Military Medical Center
state: District of Columbia
city: Miami
country: United States
facility: University of Miami Ryder Trauma Center
state: Florida
city: Orlando
country: United States
facility: Orlando Regional Medical Center
state: Florida
city: Tampa
country: United States
facility: Florida Orthopaedic Institute, St. Joseph's Hospital
state: Florida
city: Tampa
country: United States
facility: Florida Orthopaedic Institute, Tampa General Hospital
state: Florida
city: Indianapolis
country: United States
facility: Eskenazi Health
state: Indiana
city: Indianapolis
country: United States
facility: OrthoIndy Methodist Hospital
state: Indiana
city: Indianapolis
country: United States
facility: St. Vincent Indianapolis Hospital
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Medical Center
state: Iowa
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Grand Rapids
country: United States
facility: Orthopaedic Associates of Michigan
state: Michigan
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Saint Louis
country: United States
facility: Barnes Jewish Hospital
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis University Medical Center
state: Missouri
city: Jamaica
country: United States
facility: Jamaica Hospital Medical Center
state: New York
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: MetroHealth
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma University Medical Center
state: Oklahoma
city: Hershey
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island/ Brown University
state: Rhode Island
city: Nashville
country: United States
facility: Vanderbilt Medical Center
state: Tennessee
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
city: San Antonio
country: United States
facility: San Antonio Military Medical Center
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Seattle
country: United States
facility: University of Washington/Harborview Medical Center
state: Washington
Study officials:
affiliation: Carolinas Medical Center
name: Michael J Bosse, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Lisa Reider, MHS, PhD
role: STUDY_DIRECTOR
References:
citation: 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.