Transtibial Amputation Outcomes Study

Transtibial Amputation Clinical Trial

— TAOS  

Official title:

Transtibial Amputation Outcomes Study (TAOS): Comparing Transtibial Amputation With (Ertl) and Without a Tibia-fibula Synostosis Procedure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01821976
• Other study ID #: W8XWH-10-2-0090
• Status: Completed
• Phase: N/A
• Start date: March 2013
• Est. completion date: March 2020

Study information

• Verified date: November 2023
• Source: Major Extremity Trauma Research Consortium
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: March 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Transtibial Amputation

Intervention

Procedure:
• Ertl Procedure

• Burgess Procedure

Locations

Country	Name	City	State
United States	Emory University School of Medicine	Atlanta	Georgia
United States	University of Maryland/R Adams Cowley Shock Trauma Medical Center	Baltimore	Maryland
United States	Walter Reed National Military Medical Center	Bethesda	Maryland
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	MetroHealth Medical Center	Cleveland	Ohio
United States	San Antonio Miliary Medical Center	Fort Sam Houston	Texas
United States	Penn State University M.S. Hershey Medical Center	Hershey	Pennsylvania
United States	UT Health: The University of Texas Health Science Center at Houston Medical School	Houston	Texas
United States	Eskenazi Health	Indianapolis	Indiana
United States	University of Iowa Hospitals & Clinics	Iowa City	Iowa
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	University of Wisconsin School of Medicine and Public Health	Madison	Wisconsin
United States	University of Miami Ryder Trauma Center	Miami	Florida
United States	Hennepin County Medical Center	Minneapolis	Minnesota
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	University of Oklahoma	Oklahoma City	Oklahoma
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Rhode Island Hospital, Brown University	Providence	Rhode Island
United States	Barnes Jewish Hospital	Saint Louis	Missouri
United States	St. Louis University Medical Center	Saint Louis	Missouri
United States	University of California San Francisco Medical Center	San Francisco	California
United States	Florida Orthopaedic Institute- Tampa General Hospital	Tampa	Florida
United States	Wake Forest University Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Major Extremity Trauma Research Consortium

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Reported Function	Patient reported function as measured using the Short Form Musculoskeletal Assessment (SMFA) 18 months following amputation	18 Months
Primary	Number of Revision Surgeries	Number of revision surgeries to the amputated limb within 18 months after the first amputation	18 Months
Secondary	Physical Impairment	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 measured using the Step Watch activity monitor	18 Months
Secondary	Self Reported Pain	Pain measured using the Brief Pain Inventory (BPI) questionnaire	18 Months
Secondary	Treatment Costs	Initial hospitalization and overall treatment costs as determined from hospitals bills and data on utilization of outpatient health services	18 Months