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

Completed

• Conditions: Severe Ankle Injury; Severe Foot Injury; Major Soft Tissue Loss; Major Bone Articular Surface Loss; Severe Distal Tibia Injury; Major Ankle Articular Surface Loss

• Registration Number: NCT01606501
• Lead Sponsor: Major Extremity Trauma Research Consortium

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-04-16
• Study Start: 2012-05
• Study First Submitted QC: 2012-05-23
• Study First Posted: 2012-05-25
• Primary Completion: 2019-09-20
• Study Completion: 2019-09-20
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-23
• Last Update Posted: 2021-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 664

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient reported function and health related quality of life	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 Outcome Measures

Name	Time	Method
Physical impairment	18 months	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	18 months	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.

Trial Locations

Locations (33)

University of Maryland Medical Center; 🇺🇸 Baltimore, Maryland, United States

Navy Medical Center San Diego; 🇺🇸 San Diego, California, United States

Orlando Regional Medical Center; 🇺🇸 Orlando, Florida, United States

University of Miami Ryder Trauma Center; 🇺🇸 Miami, Florida, United States

Florida Orthopaedic Institute, St. Joseph's Hospital; 🇺🇸 Tampa, Florida, United States

OrthoIndy Methodist Hospital; 🇺🇸 Indianapolis, Indiana, United States

Eskenazi Health; 🇺🇸 Indianapolis, Indiana, United States

St. Vincent Indianapolis Hospital; 🇺🇸 Indianapolis, Indiana, United States

University of Iowa Medical Center; 🇺🇸 Iowa City, Iowa, United States

University of Mississippi Medical Center; 🇺🇸 Jackson, Mississippi, United States

Barnes Jewish Hospital; 🇺🇸 Saint Louis, Missouri, United States

St. Louis University Medical Center; 🇺🇸 Saint Louis, Missouri, United States

Carolinas Medical Center; 🇺🇸 Charlotte, North Carolina, United States

Oklahoma University Medical Center; 🇺🇸 Oklahoma City, Oklahoma, United States

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

Rhode Island/ Brown University; 🇺🇸 Providence, Rhode Island, United States

Vanderbilt Medical Center; 🇺🇸 Nashville, Tennessee, United States

University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States

San Antonio Military Medical Center; 🇺🇸 San Antonio, Texas, United States

University of Washington/Harborview Medical Center; 🇺🇸 Seattle, Washington, United States

University of California San Francisco Medical Center; 🇺🇸 San Francisco, California, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Jamaica Hospital Medical Center; 🇺🇸 Jamaica, New York, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

MetroHealth; 🇺🇸 Cleveland, Ohio, United States

Wake Forest Baptist Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States

Denver Health and Hospital Authority; 🇺🇸 Denver, Colorado, United States

Hennepin County Medical Center; 🇺🇸 Minneapolis, Minnesota, United States

Florida Orthopaedic Institute, Tampa General Hospital; 🇺🇸 Tampa, Florida, United States

Walter Reed National Military Medical Center; 🇺🇸 Washington, District of Columbia, United States

Orthopaedic Associates of Michigan; 🇺🇸 Grand Rapids, Michigan, United States

Penn State Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States