Major Ankle Articular Surface Loss, Major Bone Articular Surface Loss, Major Soft Tissue Loss, Severe Ankle Injury, Severe Distal Tibia Injury, Severe Foot Injury
Conditions
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).
Interventions
None listed
Sponsors
Major Extremity Trauma Research Consortium
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed