Assessment of Fixation Strategies for Severe Open Tibia Fractures
NCT ID: NCT01494519
Last Updated: 2019-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
442 participants
INTERVENTIONAL
2011-07-31
2018-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treament Arm 1
Definitive fixation with an external ring fixator.
Surgery with an external ring fixator
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.
Treatment arm 2
Definitive fixation with a locked IM nail or plate
Definitive fixation with a locked IM nail or plate
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.
Interventions
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Surgery with an external ring fixator
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 plate
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.
Eligibility Criteria
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Inclusion 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).
2. Ages 18 - 64 years inclusive
3. Study fracture is suitable for limb salvage using either a modern ring external fixator or internal fixation (internal fixation =locked intramedullary nail or plate).
Inclusion notes:
1. Patients may have co-existing non-tibial infection, with or without antibiotic treatment.
2. Patients may have risk factors for infection including diabetes, immunosuppression from steroids or other medications, HIV, or other infections.
3. Patients may have a traumatic brain injury.
4. Patients may be treated initially with a temporary external fixator prior to randomization.
5. 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.
7. Fractures may have a gap after debridement of any size, including no gap.
Exclusion Criteria
2. Patients already received definitive fixation with an IM nail, plate or ring fixator prior to study enrollment
3. Tibia already infected as diagnosed by a surgeon and currently receiving treatment for it
4. Patient speaks neither English nor Spanish
5. Patient is a prisoner
6. Patient has been diagnosed with a severe psychiatric condition
7. Patient is intellectually challenged without adequate family support
8. Patient lives outside the catchment area
9. Non-ambulatory patient due to an associated complete spinal cord injury
10. Non-ambulatory before the injury due to a pre-existing condition.
11. 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
18 Years
64 Years
ALL
No
Sponsors
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United States Department of Defense
FED
Major Extremity Trauma Research Consortium
OTHER
Responsible Party
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Principal Investigators
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Lisa Reider, MHS, PhD
Role: STUDY_DIRECTOR
Major Extremity Trauma Research Consortium
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Naval Medical Center San Diego
San Diego, California, United States
UCSF Medical Center
San Francisco, California, United States
Denver Health and Hospital Authority
Denver, Colorado, United States
University of Miami Ryder Trauma Center
Miami, Florida, United States
Orlando Regional Medical Center
Orlando, Florida, United States
Florida Orthopaedic Institute, Tampa General Hospital
Tampa, Florida, United States
Eskenazi Health
Indianapolis, Indiana, United States
OrthoIndy / Methodist Hospital
Indianapolis, Indiana, United States
St Vincent Hospital
Indianapolis, Indiana, United States
University of Maryland, R Adams Cowley Shock Trauma Center
Baltimore, Maryland, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, United States
Boston Medical Center
Boston, Massachusetts, United States
Hennepin County Medical Center / Minneapolis
Minneapolis, Minnesota, United States
Regions Hospital
Saint Paul, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
St. Louis Medical Center
St Louis, Missouri, United States
Mission Hospital
Asheville, North Carolina, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
Geisinger Health System
Danville, Pennsylvania, United States
Penn State University M.S. Hershey Medical Center
Hershey, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Texas Tech University Health Sciences Center
El Paso, Texas, United States
San Antonio Military Medical Center
Fort Sam Houston, Texas, United States
UT Health: The University of Texas Health Science Center at Houston Medical School
Houston, Texas, United States
University of Texas Health Science Center, San Antonio
San Antonio, Texas, United States
Naval Medical Center Portsmouth
Portsmouth, Virginia, United States
University of Wisconsin
Madison, Wisconsin, United States
Countries
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Other Identifiers
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W81XWH-09-2-0108
Identifier Type: -
Identifier Source: org_study_id
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