Transtibial Amputation Outcomes Study

NCT01821976 | Completed DMC

• 1 other identifier: W8XWH-10-2-0090
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 23

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.

Conditions

Transtibial Amputation

Outcome Measures

Primary Outcomes (2)

• Patient Reported Function

  Patient reported function as measured using the Short Form Musculoskeletal Assessment (SMFA) 18 months following amputation

  18 Months

• Number of Revision Surgeries

  Number of revision surgeries to the amputated limb within 18 months after the first amputation

  18 Months

Secondary Outcomes (3)

• Physical Impairment

  18 Months

• Self Reported Pain

  18 Months

• Treatment Costs

  18 Months

Study Arms (2)

Ertl Procedure

ACTIVE COMPARATOR

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

Burgess Procedure

ACTIVE COMPARATOR

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

Interventions

Ertl Procedure PROCEDURE

Ertl Procedure

Burgess Procedure PROCEDURE

Burgess Procedure

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Major Extremity Trauma Research Consortium: lead

Study Sites (23)

University of California San Francisco Medical Center

San Francisco, California, 94143, United States

Location

University of Miami Ryder Trauma Center

Miami, Florida, 33136, United States

Location

Florida Orthopaedic Institute- Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Emory University School of Medicine

Atlanta, Georgia, 30303, United States

Location

Eskenazi Health

Indianapolis, Indiana, 46202, United States

Location

University of Iowa Hospitals & Clinics

Iowa City, Iowa, 52242, United States

Location

University of Maryland/R Adams Cowley Shock Trauma Medical Center

Baltimore, Maryland, 212101, United States

Location

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

Hennepin County Medical Center

Minneapolis, Minnesota, 55430, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

St. Louis University Medical Center

St Louis, Missouri, 63110, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28232, United States

Location

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

University of Oklahoma

Oklahoma City, Oklahoma, 73104, United States

Location

Penn State University M.S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15219, United States

Location

Rhode Island Hospital, Brown University

Providence, Rhode Island, 02903, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

San Antonio Miliary Medical Center

Fort Sam Houston, Texas, 78234-6315, United States

Location

UT Health: The University of Texas Health Science Center at Houston Medical School

Houston, Texas, 77030, United States

Location

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, 53726, United States

Location

Study Officials

• Lisa Reider, MHS, PhD

  Johns Hopkins University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2013
• First Posted: April 1, 2013
• Study Start: March 1, 2013
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: December 1, 2023

Record last verified: 2023-11

Locations

US (23)