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NCT01606501 · ClinicalTrials.gov registry record
Outcomes Following Severe Distal Tibia, Ankle and/or Foot Trauma: Comparison of Limb Salvage Versus Transtibial Amputation Protocol
A clinical trial of Severe Distal Tibia Injury and Severe Ankle Injury, sponsored by Major Extremity Trauma Research Consortium.
- Completed
- Registry status
- 664
- Enrollment target
- 20
- Study locations
NCT01606501: Completed study of Severe Distal Tibia Injury and Severe Ankle Injury, sponsored by Major Extremity Trauma Research Consortium.
NCT01606501 is a study of Severe Distal Tibia Injury and Severe Ankle Injury that has completed, run by Major Extremity Trauma Research Consortium. The registered enrollment target is 664 participants. The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01606501, a study of Severe Distal Tibia Injury and Severe Ankle Injury, has completed, sponsored by Major Extremity Trauma Research Consortium.
- COMPLETED
- Registry status
- 664 participants
- Enrollment target
- 20
- Study locations
Study 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).
Primary Outcome
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).
Conditions Studied
Study Locations (20)
Florida
- University of Miami Ryder Trauma Center - Miami
- Orlando Regional Medical Center - Orlando
- Florida Orthopaedic Institute, St. Joseph's Hospital - Tampa
- Florida Orthopaedic Institute, Tampa General Hospital - Tampa
Indiana
- Eskenazi Health - Indianapolis
- OrthoIndy Methodist Hospital - Indianapolis
- St. Vincent Indianapolis Hospital - Indianapolis
California
- Navy Medical Center San Diego - San Diego
- University of California San Francisco Medical Center - San Francisco
Missouri
- Barnes Jewish Hospital - St Louis
- St. Louis University Medical Center - St Louis
Alabama
- University of Alabama at Birmingham - Birmingham
Colorado
- Denver Health and Hospital Authority - Denver
District of Columbia
- Walter Reed National Military Medical Center - Washington D.C.
Iowa
- University of Iowa Medical Center - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 664 participants |
| Start Date | 2012-05 |
| Est. Completion | 2019-09-20 |
What the finished NCT01606501 record still lists
NCT01606501 is an observational study that tracks outcomes without assigning an intervention. The registered 664 participants enrollment target is mid-sized for trials with a published cap.
The record links to 6 conditions, with Severe Distal Tibia Injury appearing as the primary indexed condition, and to 0 interventions.
NCT01606501 names 20 study sites across 13 states, led by Florida, Indiana, California.
Frequently Asked Questions
What is clinical trial NCT01606501 about?
NCT01606501 is a clinical study titled "Outcomes Following Severe Distal Tibia, Ankle and/or Foot Trauma: Comparison of Limb Salvage Versus Transtibial Amputation Protocol". 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 an...
What is the current status of trial NCT01606501?
This trial is currently completed. The enrollment target is 664 participants. The study started on 2012-05. Estimated completion is 2019-09-20.
What conditions does trial NCT01606501 study?
This clinical trial studies the following conditions: Severe Distal Tibia Injury, Severe Ankle Injury, Severe Foot Injury, Major Soft Tissue Loss, Major Bone Articular Surface Loss.
Who is sponsoring clinical trial NCT01606501?
This trial is sponsored by Major Extremity Trauma Research Consortium, which has 30 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01606501 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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