Clinical trial NCT01821976: Transtibial Amputation Outcomes Study
Official title: Transtibial Amputation Outcomes Study (TAOS): Comparing Transtibial Amputation With (Ertl) and Without a Tibia-fibula Synostosis Procedure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transtibial Amputation
Lead sponsor: Major Extremity Trauma Research Consortium
Sponsor class: OTHER
First posted: 2013-04-01
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 the Burgess procedure. Proponents of the Ertl procedure advocate that the surgical formation of a tibia to fibula bone bridge provides stability, shape and weight bearing capability to the residual limb that result in less pain and better prosthetic fit and alignment. This procedure is popular especially among the military but it's advantages over the Burgess procedure are not well supported by current research. This study aims to compare the two amputation procedures in an adequately powered randomized trial.

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, 2002; Ficke, 2007; McGuigan, 2007; Hansen, 2001). Many surgeons believe that an early transtibial amputation provides a better long term functional outcome than limb salvage for these injuries (Hansen, 2001; Myerson, 1994; Sanders, 1992; Turchin,1999; Shawen, 2010;Ellington 2012). If a transtibial amputation is selected as the treatment for the patient, a controversy remains regarding the appropriate amputation technique. Many surgeons advocate for an amputation with a tibia-fibula synostosis technique (Ertl procedure) in young and active patients, believing that this procedure provides a better prosthetic interface, an end bearing capacity and soft tissue stability that improves performance and functional outcomes. (Pinto 2004; Pinzur 2006; Commuri 2010). Others strongly advocate for a standard posterior flap (Burgess procedure) without the synostosis, arguing that patients have similar outcomes with fewer complications and lower costs. (Pinzur 2008; Tindle 2011) To date, the outcomes of the transtibial amputation techniques have not been subjected to an appropriately powered prospective randomized clinical trial.

The primary study objective is to compare functional outcomes and number of revision surgeries to the amputated limb after first amputation for patients undergoing a transtibial amputation and randomized to receive a tibia-fibula synostosis (Ertl procedure) versus a standard posterior flap procedure (Burgess procedure).

The secondary study objectives are to compare levels of impairment for patients undergoing a transtibial amputation and randomized to receive a tibia-fibula synostosis (Ertl procedure) versus a standard posterior flap procedure (Burgess procedure); to compare levels of pain for patients undergoing a transtibial amputation and randomized to receive a tibia-fibula synostosis (Ertl procedure) versus a standard posterior flap procedure (Burgess procedure); and to compare initial hospitalization and overall treatment costs (through the 18 month follow-up) for patients undergoing a transtibial amputation and are randomized to receive a tibia-fibula synostosis (Ertl procedure) versus a standard posterior flap procedure (Burgess procedure). Patients who refuse randomization have the option of participating in a prospective observational study and the type of amputation is decided by the surgeon and patient.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Patient Reported Function
timeFrame: 18 Months
measure: Number of Revision Surgeries
timeFrame: 18 Months
Secondary outcomes:
measure: Physical Impairment
timeFrame: 18 Months
measure: Self Reported Pain
timeFrame: 18 Months
measure: Treatment Costs
timeFrame: 18 Months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco Medical Center
state: California
city: Miami
country: United States
facility: University of Miami Ryder Trauma Center
state: Florida
city: Tampa
country: United States
facility: Florida Orthopaedic Institute- Tampa General Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Indianapolis
country: United States
facility: Eskenazi Health
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals & Clinics
state: Iowa
city: Baltimore
country: United States
facility: University of Maryland/R Adams Cowley Shock Trauma Medical Center
state: Maryland
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Saint Louis
country: United States
facility: Barnes Jewish Hospital
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis University Medical Center
state: Missouri
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Baptist Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma
state: Oklahoma
city: Hershey
country: United States
facility: Penn State University M.S. Hershey Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital, Brown University
state: Rhode Island
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Fort Sam Houston
country: United States
facility: San Antonio Miliary Medical Center
state: Texas
city: Houston
country: United States
facility: UT Health: The University of Texas Health Science Center at Houston Medical School
state: Texas
city: Madison
country: United States
facility: University of Wisconsin School of Medicine and Public Health
state: Wisconsin
Study officials:
affiliation: Johns Hopkins University
name: Lisa Reider, MHS, PhD
role: STUDY_DIRECTOR
References: