Transtibial Amputation Outcomes Study
Condition: Transtibial Amputation
Study type: Interventional

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.
    

Intervention name(s): Ertl Procedure; Burgess Procedure
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment