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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Limb Salvage patients | Patients undergoing limb salvage following severe distal tibia, ankle and/or foot injuries with major soft tissue, bone and/or ankle articular surface loss. | ||
| Transtibial Amputation patients | Patients undergoing transtibial amputation following severe distal tibia, ankle and/or foot injuries with major soft tissue, bone and/or ankle articular surface loss. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Physical impairment | 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. | 18 months |
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Inclusion Criteria:
Patients with an injury that meets at least one of the following:
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:
These injuries may include "toe-pan" injuries from motor vehicle accidents and crush-like injuries from motorcycle accidents, and traumatic amputations.
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:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Michael J Bosse, MD | Carolinas Medical Center | Principal Investigator |
| Lisa Reider, MHS, PhD | Johns Hopkins Bloomberg School of Public Health | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Navy Medical Center San Diego |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34425087 | Derived | 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. |
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| Levels of participation | 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. | 18 months |
| 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 | 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 |
| ID | Term |
|---|---|
| D016512 | Ankle Injuries |
| D018409 | Foot Injuries |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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