Major Ankle Articular Surface Loss Clinical Trial
— OUTLETOfficial title:
Outcomes Following Severe Distal Tibia, Ankle and/or Foot Trauma: Comparison of Limb Salvage Versus Transtibial Amputation Protocol (OUTLET Study)
| Verified date | March 2021 |
| Source | Major Extremity Trauma Research Consortium |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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).
| Status | Completed |
| Enrollment | 664 |
| Est. completion date | September 20, 2019 |
| Est. primary completion date | September 20, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 60 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Maryland Medical Center | Baltimore | Maryland |
| United States | University of Alabama at Birmingham | Birmingham | Alabama |
| United States | Carolinas Medical Center | Charlotte | North Carolina |
| United States | University of Virginia | Charlottesville | Virginia |
| United States | MetroHealth | Cleveland | Ohio |
| United States | Denver Health and Hospital Authority | Denver | Colorado |
| United States | Duke University Medical Center | Durham | North Carolina |
| United States | Orthopaedic Associates of Michigan | Grand Rapids | Michigan |
| United States | Penn State Hershey Medical Center | Hershey | Pennsylvania |
| United States | University of Texas Health Science Center at Houston | Houston | Texas |
| 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 Mississippi Medical Center | Jackson | Mississippi |
| United States | Jamaica Hospital Medical Center | Jamaica | New York |
| United States | University of Miami Ryder Trauma Center | Miami | Florida |
| United States | Hennepin County Medical Center | Minneapolis | Minnesota |
| United States | Vanderbilt Medical Center | Nashville | Tennessee |
| United States | Oklahoma University Medical Center | Oklahoma City | Oklahoma |
| United States | Orlando Regional Medical Center | Orlando | Florida |
| United States | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania |
| United States | Rhode Island/ Brown University | Providence | Rhode Island |
| United States | Barnes Jewish Hospital | Saint Louis | Missouri |
| United States | St. Louis University Medical Center | Saint Louis | Missouri |
| United States | San Antonio Military Medical Center | San Antonio | Texas |
| United States | Navy Medical Center San Diego | San Diego | California |
| United States | University of California San Francisco Medical Center | San Francisco | California |
| United States | University of Washington/Harborview Medical Center | Seattle | Washington |
| United States | Florida Orthopaedic Institute, St. Joseph's Hospital | Tampa | Florida |
| United States | Florida Orthopaedic Institute, Tampa General Hospital | Tampa | Florida |
| United States | Walter Reed National Military Medical Center | Washington | District of Columbia |
| United States | Wake Forest Baptist Medical Center | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Major Extremity Trauma Research Consortium |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Secondary | 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 | |
| Secondary | 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 |