Transtibial AmputationTAOSNCT01821976
Transtibial Amputation Outcomes Study
A study testing Ertl Procedure and Burgess Procedure in people with Transtibial Amputation, run by Major Extremity Trauma Research Consortium at 23 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Transtibial Amputation
- What is being tested?
- Ertl Procedure and Burgess Procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 199 participants
- Where
- 23 sitesUnited States
- Study dates
- Mar 2013to Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Emory University School of Medicine
Atlanta, Georgia, 30303
University of Maryland/R Adams Cowley Shock Trauma Medical Center
Baltimore, Maryland, 212101
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
Carolinas Medical Center
Charlotte, North Carolina, 28232
MetroHealth Medical Center
Cleveland, Ohio, 44109
San Antonio Miliary Medical Center
Fort Sam Houston, Texas, 78234-6315
Penn State University M.S. Hershey Medical Center
Hershey, Pennsylvania, 17033
UT Health: The University of Texas Health Science Center at Houston Medical School
Houston, Texas, 77030
Eskenazi Health
Indianapolis, Indiana, 46202
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242
University of Mississippi Medical Center
Jackson, Mississippi, 39216
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, 53726
University of Miami Ryder Trauma Center
Miami, Florida, 33136
Hennepin County Medical Center
Minneapolis, Minnesota, 55430
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
University of Oklahoma
Oklahoma City, Oklahoma, 73104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15219
Rhode Island Hospital, Brown University
Providence, Rhode Island, 02903
University of California San Francisco Medical Center
San Francisco, California, 94143
Barnes Jewish Hospital
St Louis, Missouri, 63110
St. Louis University Medical Center
St Louis, Missouri, 63110
Florida Orthopaedic Institute- Tampa General Hospital
Tampa, Florida, 33606
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
Official title: Transtibial Amputation Outcomes Study (TAOS): Comparing Transtibial Amputation With (Ertl) and Without a Tibia-fibula Synostosis Procedure
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.
Read the 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.
- Conditions
- Transtibial Amputation
- Being tested
- Ertl Procedure, Burgess Procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ertl ProcedureProcedure or surgery
Burgess ProcedureProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Burgess Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Reported Function
Patient reported function as measured using the Short Form Musculoskeletal Assessment (SMFA) 18 months following amputation
Measured: 18 Months
Number of Revision Surgeries
Number of revision surgeries to the amputated limb within 18 months after the first amputation
Measured: 18 Months
Secondary outcomes (3)
Physical Impairment
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
Measured: 18 Months
Self Reported Pain
Pain measured using the Brief Pain Inventory (BPI) questionnaire
Measured: 18 Months
Treatment Costs
Initial hospitalization and overall treatment costs as determined from hospitals bills and data on utilization of outpatient health services
Measured: 18 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionMar 2020
- Study completionMar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transtibial AmputationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Major Extremity Trauma Research Consortium
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisa Reider, MHS, PhD, Study director, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01821976
- Sponsor's protocol ID
- W8XWH-10-2-0090
- Acronym
- TAOS
- Status last verified
- Nov 2023
- First submitted
- 27 Mar 2013
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transtibial Amputation Outcomes Study (TAOS): Comparing Transtibial Amputation With (Ertl) and Without a Tibia-fibula Synostosis Procedure
- ClinicalTrials.gov ID
- NCT01821976
- Acronym / sponsor ID
- TAOS / W8XWH-10-2-0090
- Conditions
- Transtibial Amputation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Major Extremity Trauma Research ConsortiumUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Mar 2020 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 1 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ertl Procedure | Active comparator | Procedure: Ertl ProcedurePatients 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. |
| Burgess Procedure | Active comparator | Procedure: Burgess ProcedurePatients 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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:
- Ages 18 and 60 inclusive
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ertl Procedure | Procedure or surgery | Ertl Procedure |
| Burgess Procedure | Procedure or surgery | Burgess Procedure |
Primary outcome
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
3 secondary outcomes
Physical Impairment
Time frame: 18 Months
Self Reported Pain
Time frame: 18 Months
Treatment Costs
Time frame: 18 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Reider, MHS, PhD study director
Johns Hopkins University
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ertl Procedure and Burgess Procedure in people with Transtibial Amputation, run by Major Extremity Trauma Research Consortium at 23 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Reported Function (time frame: 18 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.