Severe Open Fractures of the Tibia (Shin) BonePhase 3FIXITNCT01494519
Assessment of Fixation Strategies for Severe Open Tibia Fractures
A Phase 3 study testing Surgery with an external ring fixator and Definitive fixation with a locked IM nail or plate in people with Severe Open Fractures of the Tibia (Shin) Bone, run by Major Extremity Trauma Research Consortium at 33 sites in United States.
Trial summary
The purpose of this study is to compare the use of modern ring external fixation versus internal fixation for fracture stabilization of severe open tibia fractures. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Severe Open Fractures of the Tibia (Shin) Bone
- What is being tested?
- Surgery with an external ring fixator and Definitive fixation with a locked IM nail or plate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 442 participants
- Where
- 33 sitesUnited States
- Study dates
- Jul 2011to Sep 2018
- Phase
- Phase 3
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All open tibia fractures meeting at least one of 1 the following criteria:
- Diaphyseal or metaphyseal Type IIIB (Gustilo IIIB Fractures are open fractures that require either a rotational or free flap for coverage of a soft tissue defect).
- Diaphyseal or metaphyseal Type IIIA where extensive contamination or muscle damage (e.g. all military injuries from IED) precludes nail/plate placement at first debridement.
- Diaphyseal or metaphyseal Type IIIA, where injury would have been classified as a IIIB, but because enough muscle was removed, the skin could be closed.
- Diaphyseal or metaphyseal Type IIIA, where after debridement, bone gap is greater than 1cm.
- Diaphyseal or metaphyseal Type IIIA, where fasciotomies were performed for impending or diagnosed compartment syndrome, and wounds could not be closed primarily (i.e. needs skin grafting).
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- Ages 18 - 64 years inclusive
- Study fracture is suitable for limb salvage using either a modern ring external fixator or internal fixation (internal fixation =locked intramedullary nail or plate).
- Patients may have co-existing non-tibial infection, with or without antibiotic treatment.
- Patients may have risk factors for infection including diabetes, immunosuppression from steroids or other medications, HIV, or other infections.
- Patients may have a traumatic brain injury.
- Patients may be treated initially with a temporary external fixator prior to randomization.
- Patients may be treated initially at an outside institution prior to transfer to the study institution, as long as the definitive fixation was not performed prior to entrance into the study.
- Patients with bilateral injuries that meet inclusion criteria may be included, but only the limb rated as "more severe" by the treating surgeon will be enrolled in the study.
- Fractures may have a gap after debridement of any size, including no gap.
Who cannot join
- Patients presenting with a traumatic amputation of the tibia
- Patients already received definitive fixation with an IM nail, plate or ring fixator prior to study enrollment
- Tibia already infected as diagnosed by a surgeon and currently receiving treatment for it
- Patient speaks neither English nor Spanish
- Patient is a prisoner
- Patient has been diagnosed with a severe psychiatric condition
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- Patient is intellectually challenged without adequate family support
- Patient lives outside the catchment area
- Non-ambulatory patient due to an associated complete spinal cord injury
- Non-ambulatory before the injury due to a pre-existing condition.
- Complex pilon and plateau fractures. The study tibia fracture may have extension into the joint surface, but should primarily be a metaphyseal or diaphyseal fracture and not have an ipsilateral tibial plateau or pilon fracture.Contralateral tibial plateau and pilon fractures are allowed
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
United States33 sites
Mission Hospital
Asheville, North Carolina, 28801
University of Maryland, R Adams Cowley Shock Trauma Center
Baltimore, Maryland, 21201
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Boston Medical Center
Boston, Massachusetts, 02118
Carolinas Medical Center
Charlotte, North Carolina, 28232
MetroHealth Medical Center
Cleveland, Ohio, 44109
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Geisinger Health System
Danville, Pennsylvania, 17822
Denver Health and Hospital Authority
Denver, Colorado, 80204
Texas Tech University Health Sciences Center
El Paso, Texas, 79905
San Antonio Military 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
OrthoIndy / Methodist Hospital
Indianapolis, Indiana, 46202
St Vincent Hospital
Indianapolis, Indiana, 46260
University of Mississippi Medical Center
Jackson, Mississippi, 39216
University of Wisconsin
Madison, Wisconsin, 53705
University of Miami Ryder Trauma Center
Miami, Florida, 33101
Hennepin County Medical Center / Minneapolis
Minneapolis, Minnesota, 55415
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Orlando Regional Medical Center
Orlando, Florida, 32806
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Naval Medical Center Portsmouth
Portsmouth, Virginia, 23708
Regions Hospital
Saint Paul, Minnesota, 55101
University of Texas Health Science Center, San Antonio
San Antonio, Texas, 78229
Naval Medical Center San Diego
San Diego, California, 92134
UCSF Medical Center
San Francisco, California, 94115
St. Louis 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, 27157-1070
About this study
Official title: A Prospective Randomized Trial to Assess Fixation Strategies for Severe Open Tibia Fractures:Modern Ring External Fixators Versus Internal Fixation
The purpose of this study is to compare the use of modern ring external fixation versus internal fixation for fracture stabilization of severe open tibia fractures.
Read the detailed description
Severe open fractures of the tibia (shin) bone are difficult to treat and are associated with high rates of infection and other complications. There is controversy regarding the best treatment, particularly in fractures with large wounds from trauma. The two current standard treatment options are to place an internal fixation device (a nail or plates with screws) or to use a device with pins that stick out of the skin and attach to rings outside the body (modern ring external fixator). It is unknown which of these standard of care treatment options will result in lower complication rates and better function of the leg.
Our goal is to perform a multi-center randomized controlled trial of the use of modern ring external fixation versus internal fixation for fracture stabilization of severe open tibia fractures. Patients who refuse randomization have the option of participating in a prospective observational study and the treatment is decided by the surgeon and patient.
Primary Aim: To compare the outcomes associated with modern ring external fixators versus standard internal fixation techniques in treating "severe" open tibia shaft or metaphyseal fractures with or without a bone defect of any size.
Primary Hypothesis: Among patients with open tibia shaft or metaphyseal fractures (with or without a bone defect of any size), the rate of re-hospitalization for major limb complications will be lower for patients treated with ring fixators than those treated with standard internal fixation.
Secondary Hypotheses: Among patients with open tibia shaft or metaphyseal fractures (with or without a bone defect of any size), the overall rate of infections will be lower for patients treated with ring fixators than those treated with standard internal fixation. Measures of fracture healing, limb function, and patient reported outcomes (including pain) will be as good or better among patients treated with ring fixators than those treated with standard internal fixation.
Secondary Aim #1: To determine the percentage of Gustilo IIIB open tibia shaft fractures that can be treated successfully (i.e. without amputation) without a soft tissue flap secondary to the use of ring external fixators.
Secondary Aim #2: To determine the two-year treatment costs associated with fixation of "severe" open tibia shaft or metaphyseal fractures (with or without a bone defect of any size) using modern ring external fixators versus standard internal fixation techniques.
Secondary Aim #3: To determine patient reported levels of satisfaction with the fixation method and overall treatment and to compare satisfaction between the two treatment groups.
- Being tested
- Surgery with an external ring fixator, Definitive fixation with a locked IM nail or plate
- Keywords
- External ring fixation, internal fixation, traumatic tibia fracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery with an external ring fixatorProcedure or surgery
Modern ring external fixator is defined as any fixator that has at least 1 ring proximal and 1 ring distal to the fracture site. The rings may be connected to the tibia using any combination of external fixation pins or wires at the surgeon's discretion. There must be at least two pins or wires connected to each ring, and typically there will be at least three pins or wires. Any FDA approved ring fixator meeting this definition from any manufacturer is allowed.
Definitive fixation with a locked IM nail or plateProcedure or surgery
Eligible patients with tibial diaphyseal fractures will typically receive a standard locked IM Nail. The nail must use at least one static interlock proximal to and one static interlock distal to the fracture site. The nail may be placed with either a reamed or unreamed technique.
Methaphyseal fractures, especially those with fracture lines extending into the joint may be more commonly treated with plate fixation. The plate may be applied in an open or percutaneous fashion. Any combination of locked and/or non-locked screws may be used.
| Study group | Role | What they receive |
|---|---|---|
| Treament Arm 1 | Active comparator | Definitive fixation with an external ring fixator. Receives: Procedure: Surgery with an external ring fixator |
| Treatment arm 2 | Active comparator | Definitive fixation with a locked IM nail or plate Receives: Procedure: Definitive fixation with a locked IM nail or plate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Re-hospitalization for Complication.
A hospital re-admission for a complication is defined as any re-admission to the hospital secondary to the treatment of the open tibia fracture for a defined set of complications. The list of complications includes: amputation (at any level), infection (defined using CDC criteria), flap failure, non-union, mal-union, loss of reduction, or hardware failure.
Measured: 2 years
Secondary outcomes (7)
Infection.
Infection is defined as either deep or superficial. The presence of tibia infection will be defined by the criteria of CDC. Deep infections are further defined as those that require operative treatment. Superficial infections are defined as those that are treated only with local antibiotics and wound care, and no operative treatment for the infection.
Measured: 2 years
Fracture Healing.
Fractures will be evaluated with standard 2 view radiographs of the tibia as is currently performed in standard practice at every clinic visit after the 2 week follow-up. Fracture healing is measured by the treating surgeon using standard clinical criteria.
Measured: 2 years
Limb Function.
Limb function will be measured using standard clinical assessments to include weight bearing and ambulation status, knee and ankle range of motion and self selected walking speed.
Measured: 2 years
Patient Reported Outcome and Quality of Life.
Outcomes from the patients' perspective will be assessed using standardized questionnaires including the VR-12, the SMFA, and the Paffenbarger activity scale. Depression will be assessed using the PHQ. Post traumatic stress will be measured using the PCL-S.
Measured: 2 years
Brief Pain Inventory Scores
Pain will be measured using the visual analogue scale (VAS), the brief pain inventory (BPI) and documentation of use of pain medications.
Measured: 2 years
Satisfaction with treatment
Patient satisfaction with treatment will be measured using the Short Form Patient Satisfaction Questionnaire (PSQ-18).
Measured: 2 years
Health Care Costs
Costs for the initial hospitalization and subsequent care will be estimated using electronic billing records and self reported health service utilization.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2011 (estimated)
- Study startJul 2011
- Primary completionSep 2017
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Open Fractures of the Tibia (Shin) BoneStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 442 participants (actual)
Sponsor and investigators
- Lead sponsor
- Major Extremity Trauma Research Consortium
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Lisa Reider, MHS, PhD, Study director, Major Extremity Trauma Research Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01494519
- Sponsor's protocol ID
- W81XWH-09-2-0108
- Acronym
- FIXIT
- Status last verified
- Feb 2019
- First submitted
- 25 Aug 2011
- 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
- A Prospective Randomized Trial to Assess Fixation Strategies for Severe Open Tibia Fractures:Modern Ring External Fixators Versus Internal Fixation
- ClinicalTrials.gov ID
- NCT01494519
- Acronym / sponsor ID
- FIXIT / W81XWH-09-2-0108
- Keywords
- External ring fixation, internal fixation, traumatic tibia fracture
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 442 participants (actual)
- Lead sponsor
- Major Extremity Trauma Research ConsortiumUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Jul 2011
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 19 Dec 2011 (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 purpose of this study is to compare the use of modern ring external fixation versus internal fixation for fracture stabilization of severe open tibia fractures.
Detailed description
Severe open fractures of the tibia (shin) bone are difficult to treat and are associated with high rates of infection and other complications. There is controversy regarding the best treatment, particularly in fractures with large wounds from trauma. The two current standard treatment options are to place an internal fixation device (a nail or plates with screws) or to use a device with pins that stick out of the skin and attach to rings outside the body (modern ring external fixator). It is unknown which of these standard of care treatment options will result in lower complication rates and better function of the leg.
Our goal is to perform a multi-center randomized controlled trial of the use of modern ring external fixation versus internal fixation for fracture stabilization of severe open tibia fractures. Patients who refuse randomization have the option of participating in a prospective observational study and the treatment is decided by the surgeon and patient.
Primary Aim: To compare the outcomes associated with modern ring external fixators versus standard internal fixation techniques in treating "severe" open tibia shaft or metaphyseal fractures with or without a bone defect of any size.
Primary Hypothesis: Among patients with open tibia shaft or metaphyseal fractures (with or without a bone defect of any size), the rate of re-hospitalization for major limb complications will be lower for patients treated with ring fixators than those treated with standard internal fixation.
Secondary Hypotheses: Among patients with open tibia shaft or metaphyseal fractures (with or without a bone defect of any size), the overall rate of infections will be lower for patients treated with ring fixators than those treated with standard internal fixation. Measures of fracture healing, limb function, and patient reported outcomes (including pain) will be as good or better among patients treated with ring fixators than those treated with standard internal fixation.
Secondary Aim #1: To determine the percentage of Gustilo IIIB open tibia shaft fractures that can be treated successfully (i.e. without amputation) without a soft tissue flap secondary to the use of ring external fixators.
Secondary Aim #2: To determine the two-year treatment costs associated with fixation of "severe" open tibia shaft or metaphyseal fractures (with or without a bone defect of any size) using modern ring external fixators versus standard internal fixation techniques.
Secondary Aim #3: To determine patient reported levels of satisfaction with the fixation method and overall treatment and to compare satisfaction between the two treatment groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treament Arm 1 | Active comparator | Procedure: Surgery with an external ring fixatorDefinitive fixation with an external ring fixator. |
| Treatment arm 2 | Active comparator | Procedure: Definitive fixation with a locked IM nail or plateDefinitive fixation with a locked IM nail or plate |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- All open tibia fractures meeting at least one of 1 the following criteria:
- Ages 18 - 64 years inclusive
- Study fracture is suitable for limb salvage using either a modern ring external fixator or internal fixation (internal fixation =locked intramedullary nail or plate).
- Patients may have co-existing non-tibial infection, with or without antibiotic treatment.
- Patients may have risk factors for infection including diabetes, immunosuppression from steroids or other medications, HIV, or other infections.
Key exclusion criteria (11 listed)
- Patients presenting with a traumatic amputation of the tibia
- Patients already received definitive fixation with an IM nail, plate or ring fixator prior to study enrollment
- Tibia already infected as diagnosed by a surgeon and currently receiving treatment for it
- Patient speaks neither English nor Spanish
- Patient is a prisoner
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 |
|---|---|---|
| Surgery with an external ring fixatorModern ring external fixator is defined as any fixator that has at least 1 ring proximal and 1 ring distal to the fracture site. The rings may be connected to the tibia using any combination of external fixation pins or wires at the surgeon's discretion. There must be at least two pins or wires connected to each ring, and typically there will be at least three pins or wires. Any FDA approved ring fixator meeting this definition from any manufacturer is allowed. | Procedure or surgery | Treament Arm 1 |
| Definitive fixation with a locked IM nail or plateEligible patients with tibial diaphyseal fractures will typically receive a standard locked IM Nail. The nail must use at least one static interlock proximal to and one static interlock distal to the fracture site. The nail may be placed with either a reamed or unreamed technique. Methaphyseal fractures, especially those with fracture lines extending into the joint may be more commonly treated with plate fixation. The plate may be applied in an open or percutaneous fashion. Any combination of locked and/or non-locked screws may be used. | Procedure or surgery | Treatment arm 2 |
Primary outcome
Re-hospitalization for Complication.
Time frame: 2 years
A hospital re-admission for a complication is defined as any re-admission to the hospital secondary to the treatment of the open tibia fracture for a defined set of complications. The list of complications includes: amputation (at any level), infection (defined using CDC criteria), flap failure, non-union, mal-union, loss of reduction, or hardware failure.
7 secondary outcomes
Infection.
Time frame: 2 years
Fracture Healing.
Time frame: 2 years
Limb Function.
Time frame: 2 years
Patient Reported Outcome and Quality of Life.
Time frame: 2 years
Brief Pain Inventory Scores
Time frame: 2 years
Satisfaction with treatment
Time frame: 2 years
Health Care Costs
Time frame: 2 years
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.
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
Major Extremity Trauma Research Consortium
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Surgery with an external ring fixator and Definitive fixation with a locked IM nail or plate in people with Severe Open Fractures of the Tibia (Shin) Bone, run by Major Extremity Trauma Research Consortium at 33 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 15 inclusion and 11 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 33 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Re-hospitalization for Complication. (time frame: 2 years). 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.