Status:
COMPLETED
Transtibial Amputation Outcomes Study
Lead Sponsor:
Major Extremity Trauma Research Consortium
Conditions:
Transtibial Amputation
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
The goals of the TAOS study is to determine the best procedures for below the knee amputations. There are two different procedures currently used by surgeons around the county: the Erlt procedure and ...
Detailed Description
High-energy open fractures, blast, gunshot wound and crush injuries to the distal tibia, ankle, hind foot and midfoot are common challenges to military and civilian trauma surgeons (Brown, 2009; Covey...
Eligibility Criteria
Inclusion
- Patients requiring a unilateral transtibial amputation following major limb trauma regardless of when the injury occurred
- The injury and its treatment must meet the following criteria:
- The residual fibula is not fractured or if fractured, is stabilized by internal fixation allowing for either the Ertl or Burgess procedure
- Proximal tibia/fibula joint is stabilized
- Soft tissue coverage allows for atypical closure and skin graft \<100 cm2
- Amputation will result in a residual limb that is ≥10 cm from joint line to end of tibia
- Ages 18 and 60 inclusive
Exclusion
- At time of consent, patient has a Glasgow Coma Scale (GCS) motor score of 0-4 or a GCS motor score of 5 with a significant traumatic brain injury (defined as an AIS code of 5 or 6)
- Patients with wound closure requiring a free tissue transfer
- Fibula fractures proximal to the tibial bone cut that cannot be stabilized
- Late amputation with presence of one of the following conditions: (i) infection within the zone of injury; (ii) chronic regional pain syndrome; (iii) post-traumatic thrombophlebitis
- Patient has a spinal cord deficit
- Patient has a previous leg or foot amputation or is non-ambulatory pre-injury
- Patient has third degree burns on \>10% total surface area affecting the study limb
- Patient has a documented psychiatric disorder
- Patient is unable to speak either English or Spanish
- Severe problems with maintaining follow-up (e.g. patients who are prisoners or homeless at the time of injury or who are intellectually challenged without adequate family support).
- Patient has an amputation to one or both upper extremities (excluding digits)
- Patient is outside hospital's catchment area
- Patient follow-up is planned at another medical center
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2020
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT01821976
Start Date
March 1 2013
End Date
March 1 2020
Last Update
December 1 2023
Active Locations (23)
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1
University of California San Francisco Medical Center
San Francisco, California, United States, 94143
2
University of Miami Ryder Trauma Center
Miami, Florida, United States, 33136
3
Florida Orthopaedic Institute- Tampa General Hospital
Tampa, Florida, United States, 33606
4
Emory University School of Medicine
Atlanta, Georgia, United States, 30303