Transtibial Amputation Outcomes Study (TAOS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Major Extremity Trauma Research Consortium
Sponsor:
Information provided by (Responsible Party):
Major Extremity Trauma Research Consortium
ClinicalTrials.gov Identifier:
NCT01821976
First received: March 27, 2013
Last updated: NA
Last verified: March 2013
History: No changes posted
  Purpose

The goal of the TAOS study is to determine the best procedure for below the knee amputations. There are two different procedures currently used by surgeons around the country: the Ertl procedure and the Burgess procedure. We do not know what procedure is best for patients. The TAOS study will help us find out which of these two procedures is best.


Condition Intervention
Transtibial Amputation
Procedure: Ertl Procedure
Procedure: Burgess Procedure

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Transtibial Amputation Outcomes Study (TAOS): Comparing Transtibial Amputation With and Without a Tibia-fibula Synostosis (Ertl) Procedure

Further study details as provided by Major Extremity Trauma Research Consortium:

Primary Outcome Measures:
  • Patient Reported Function [ Time Frame: 18 Months ] [ Designated as safety issue: No ]
    Patient reported function as measured using the Short Form Musculoskeletal Assessment (SMFA) 18 months following amputation

  • Number of Revision Surgeries [ Time Frame: 18 Months ] [ Designated as safety issue: No ]
    Number of revision surgeries to the amputated limb within 18 months after the first amputation


Secondary Outcome Measures:
  • Physical Impairment [ Time Frame: 18 Months ] [ Designated as safety issue: No ]
    Physical impairment determined using objective performance measures of agility, strength/power, speed, endurance and balance as well as overall activity measured using the Step Watch activity monitor

  • Pain [ Time Frame: 18 Months ] [ Designated as safety issue: No ]
    Pain measured using the Brief Pain Inventory (BPI) questionnaire

  • Treatment Costs [ Time Frame: 18 Months ] [ Designated as safety issue: No ]
    Initial hospitalization and overall treatment costs as determined from hospitals bills and data on utilization of outpatient health services


Estimated Enrollment: 250
Study Start Date: March 2013
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ertl Procedure
Patients randomized to the Ertl Procedure Arm will receive an amputation very similar to the Burgess Procedure, except the surgeon will perform an additional step to make the cut end of the tibia bone heal to the cut end of the fibula bone with a bone bridge. This bone bridge connects the two bones together.
Procedure: Ertl Procedure
Active Comparator: Burgess Procedure
Patients randomized to the Burgess Procedure Arm will receive a below the knee amputation where the bone is cut and skin and muscle from the back of the leg are rotated to cover the cut end of your bone. This provides good soft tissue padding to the bone and a good shape to the leg for later fitting of your prosthesis.
Procedure: Burgess Procedure

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).

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ages 18 and 60 inclusive
  • 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 fractured and 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

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01821976

Contacts
Contact: Michael J Bosse, MD 704-355-6046 michael.bosse@carolinashealthcare.org

  Show 24 Study Locations
Sponsors and Collaborators
Major Extremity Trauma Research Consortium
  More Information

No publications provided

Responsible Party: Major Extremity Trauma Research Consortium
ClinicalTrials.gov Identifier: NCT01821976     History of Changes
Other Study ID Numbers: W8XWH-10-2-0090
Study First Received: March 27, 2013
Last Updated: March 27, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 18, 2014