Outcomes Following Severe Distal Tibia, Ankle and/or Foot Trauma: Comparison of Limb Salvage Versus Transtibial Amputation Protocol
Public ClinicalTrials.gov record NCT01606501. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Outcomes Following Severe Distal Tibia, Ankle and/or Foot Trauma: Comparison of Limb Salvage Versus Transtibial Amputation Protocol (OUTLET Study)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT01606501
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 664 participants
Conditions and interventions
Conditions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- 18 Years to 60 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 30, 2012
- Primary completion
- Sep 19, 2019
- Completion
- Sep 19, 2019
- Last update posted
- Mar 23, 2021
2012 – 2019
United States locations
- U.S. sites
- 33
- U.S. states
- 22
- U.S. cities
- 29
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | — |
| Navy Medical Center San Diego | San Diego | California | 92134 | — |
| University of California San Francisco Medical Center | San Francisco | California | 94143 | — |
| Denver Health and Hospital Authority | Denver | Colorado | 80204 | — |
| Walter Reed National Military Medical Center | Washington D.C. | District of Columbia | 20307 | — |
| University of Miami Ryder Trauma Center | Miami | Florida | 33136 | — |
| Orlando Regional Medical Center | Orlando | Florida | 32806 | — |
| Florida Orthopaedic Institute, St. Joseph's Hospital | Tampa | Florida | 33606 | — |
| Florida Orthopaedic Institute, Tampa General Hospital | Tampa | Florida | 33606 | — |
| Eskenazi Health | Indianapolis | Indiana | 46202 | — |
| OrthoIndy Methodist Hospital | Indianapolis | Indiana | 46202 | — |
| St. Vincent Indianapolis Hospital | Indianapolis | Indiana | 46260 | — |
| University of Iowa Medical Center | Iowa City | Iowa | 52242 | — |
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | — |
| Orthopaedic Associates of Michigan | Grand Rapids | Michigan | 49525 | — |
| Hennepin County Medical Center | Minneapolis | Minnesota | 55430 | — |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | — |
| Barnes Jewish Hospital | St Louis | Missouri | 63110 | — |
| St. Louis University Medical Center | St Louis | Missouri | 63110 | — |
| Jamaica Hospital Medical Center | Jamaica | New York | 11418 | — |
| Carolinas Medical Center | Charlotte | North Carolina | 28203 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | 27103 | — |
| MetroHealth | Cleveland | Ohio | 44109 | — |
| Oklahoma University Medical Center | Oklahoma City | Oklahoma | 73104 | — |
| Penn State Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | — |
| Rhode Island/ Brown University | Providence | Rhode Island | 02905 | — |
| Vanderbilt Medical Center | Nashville | Tennessee | 37232 | — |
| University of Texas Health Science Center at Houston | Houston | Texas | 77030 | — |
| San Antonio Military Medical Center | San Antonio | Texas | 78434 | — |
| University of Virginia | Charlottesville | Virginia | 22908 | — |
| University of Washington/Harborview Medical Center | Seattle | Washington | 98104 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01606501, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 23, 2021 · Synced Sep 10, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01606501 live on ClinicalTrials.gov.