NCT01606501|CompletedDMC
Outcomes Following Severe Distal Tibia, Ankle and/or Foot Trauma: Comparison of Limb Salvage Versus Transtibial Amputation Protocol
OUTLET
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OUTLET
Sponsor study identifier
observational
664
1 country
33
Study Start
May 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 20, 2019
Actual (reported)Study Completion
September 20, 2019
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 20, 2019
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 16, 2012
Actual (reported)May 2012
Date type not reportedThis date has not been verified as actual or estimated.
May 25, 2012
Actual (reported)September 20, 2019
Actual (reported)September 20, 2019
Actual (reported)Patient reported function and health related quality of life
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).
18 months
Physical impairment
18 months
Levels of participation
18 months
Patients undergoing limb salvage following severe distal tibia, ankle and/or foot injuries with major soft tissue, bone and/or ankle articular surface loss.
Patients undergoing transtibial amputation following severe distal tibia, ankle and/or foot injuries with major soft tissue, bone and/or ankle articular surface loss.
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.
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Navy Medical Center San Diego
San Diego, California, 92134, United States
University of California San Francisco Medical Center
San Francisco, California, 94143, United States
Denver Health and Hospital Authority
Denver, Colorado, 80204, United States
Walter Reed National Military Medical Center
Washington D.C., District of Columbia, 20307, United States
University of Miami Ryder Trauma Center
Miami, Florida, 33136, United States
Orlando Regional Medical Center
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.
Michael J Bosse, MD
Carolinas Medical Center
Lisa Reider, MHS, PhD
Johns Hopkins Bloomberg School of Public Health
664 participants (actual enrollment reported by the registry).
First Submitted
April 16, 2012
First Posted
May 25, 2012
Study Start
May 2012
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Orlando, Florida, 32806, United States
Florida Orthopaedic Institute, St. Joseph's Hospital
Tampa, Florida, 33606, United States
Florida Orthopaedic Institute, Tampa General Hospital
Tampa, Florida, 33606, United States
Eskenazi Health
Indianapolis, Indiana, 46202, United States
OrthoIndy Methodist Hospital
Indianapolis, Indiana, 46202, United States
St. Vincent Indianapolis Hospital
Indianapolis, Indiana, 46260, United States
University of Iowa Medical Center
Iowa City, Iowa, 52242, United States
University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
Orthopaedic Associates of Michigan
Grand Rapids, Michigan, 49525, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55430, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Barnes Jewish Hospital
St Louis, Missouri, 63110, United States
St. Louis University Medical Center
St Louis, Missouri, 63110, United States
Jamaica Hospital Medical Center
Jamaica, New York, 11418, United States
Carolinas Medical Center
Charlotte, North Carolina, 28203, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27103, United States
MetroHealth
Cleveland, Ohio, 44109, United States
Oklahoma University Medical Center
Oklahoma City, Oklahoma, 73104, United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Rhode Island/ Brown University
Providence, Rhode Island, 02905, United States
Vanderbilt Medical Center
Nashville, Tennessee, 37232, United States
University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
San Antonio Military Medical Center
San Antonio, Texas, 78434, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
University of Washington/Harborview Medical Center
Seattle, Washington, 98104, United States
Primary Completion
September 20, 2019
Actual (reported)Study Completion
September 20, 2019
Actual (reported)Last Updated
March 24, 2021
Record last verified: 2021-03
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