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Trial record 7 of 100 for:    Recruiting, Not yet recruiting, Available Studies | amputation

Transtibial Amputation Outcomes Study (TAOS)

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ClinicalTrials.gov Identifier: NCT01821976
Recruitment Status : Recruiting
First Posted : April 1, 2013
Last Update Posted : June 14, 2017
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Transtibial Amputation Procedure: Ertl Procedure 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). 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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transtibial Amputation Outcomes Study (TAOS): Comparing Transtibial Amputation With (Ertl) and Without a Tibia-fibula Synostosis Procedure
Study Start Date : March 2013
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : June 2022
Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. Patient Reported Function [ Time Frame: 18 Months ]
    Patient reported function as measured using the Short Form Musculoskeletal Assessment (SMFA) 18 months following amputation

  2. Number of Revision Surgeries [ Time Frame: 18 Months ]
    Number of revision surgeries to the amputated limb within 18 months after the first amputation

Secondary Outcome Measures :
  1. Physical Impairment [ Time Frame: 18 Months ]
    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

  2. Pain [ Time Frame: 18 Months ]
    Pain measured using the Brief Pain Inventory (BPI) questionnaire

  3. Treatment Costs [ Time Frame: 18 Months ]
    Initial hospitalization and overall treatment costs as determined from hospitals bills and data on utilization of outpatient health services

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01821976

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

  Show 28 Study Locations
Sponsors and Collaborators
Major Extremity Trauma Research Consortium
Study Director: Lisa Reider, MHS, PhD Johns Hopkins University
More Information

Responsible Party: Major Extremity Trauma Research Consortium
ClinicalTrials.gov Identifier: NCT01821976     History of Changes
Other Study ID Numbers: W8XWH-10-2-0090
First Posted: April 1, 2013    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: April 2017