Transtibial Amputation Outcomes Study (TAOS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01821976|
Recruitment Status : Recruiting
First Posted : April 1, 2013
Last Update Posted : June 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Transtibial Amputation||Procedure: Ertl Procedure Procedure: Burgess Procedure||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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|
- Patient Reported Function [ Time Frame: 18 Months ]Patient reported function as measured using the Short Form Musculoskeletal Assessment (SMFA) 18 months following amputation
- Number of Revision Surgeries [ Time Frame: 18 Months ]Number of revision surgeries to the amputated limb within 18 months after the first amputation
- 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
- Pain [ Time Frame: 18 Months ]Pain measured using the Brief Pain Inventory (BPI) questionnaire
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01821976
|Contact: Michael J Bosse, MDemail@example.com|
Show 28 Study Locations
|Study Director:||Lisa Reider, MHS, PhD||Johns Hopkins University|