Transtibial Amputation Outcomes Study

Not Applicable

Completed

• Conditions: Transtibial Amputation

• Registration Number: NCT01821976
• Lead Sponsor: Major Extremity Trauma Research Consortium

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.

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 Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-27
• Study First Submitted QC: 2013-03-27
• Study First Posted: 2013-04-01
• Primary Completion: 2020-03
• Study Completion: 2020-03
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-30
• Last Update Posted: 2023-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Patient Reported Function	18 Months	Patient reported function as measured using the Short Form Musculoskeletal Assessment (SMFA) 18 months following amputation
Number of Revision Surgeries	18 Months	Number of revision surgeries to the amputated limb within 18 months after the first amputation

Secondary Outcome Measures

Name	Time	Method
Physical Impairment	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
Self Reported Pain	18 Months	Pain measured using the Brief Pain Inventory (BPI) questionnaire
Treatment Costs	18 Months	Initial hospitalization and overall treatment costs as determined from hospitals bills and data on utilization of outpatient health services

Trial Locations

Locations (23)

University of California San Francisco Medical Center; 🇺🇸 San Francisco, California, United States

University of Miami Ryder Trauma Center; 🇺🇸 Miami, Florida, United States

Florida Orthopaedic Institute- Tampa General Hospital; 🇺🇸 Tampa, Florida, United States

Emory University School of Medicine; 🇺🇸 Atlanta, Georgia, United States

Eskenazi Health; 🇺🇸 Indianapolis, Indiana, United States

University of Iowa Hospitals & Clinics; 🇺🇸 Iowa City, Iowa, 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

Hennepin County Medical Center; 🇺🇸 Minneapolis, Minnesota, United States

University of Mississippi Medical Center; 🇺🇸 Jackson, Mississippi, United States

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