Assessment of Fixation Strategies for Severe Open Tibia Fractures



Status:Completed
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:18 - 64
Updated:2/9/2019
Start Date:July 2011
End Date:September 2018

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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.

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.

Inclusion Criteria:

1. 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).

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.

6. 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.

7. Fractures may have a gap after debridement of any size, including no gap.

Exclusion Criteria:

1. Patients presenting with a traumatic amputation of the tibia

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
We found this trial at
33
sites
1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
Principal Investigator: Adam J Starr, MD
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Jason Lowe, MD
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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1000 Blythe Blvd
Charlotte, North Carolina 28203
(704) 355-2000
Principal Investigator: Michael J. Bosse, MD
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
Principal Investigator: George Russell, MD
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Alex Jahangir, MD, MPH
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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1414 Kuhl Avenue
Orlando, Florida 32806
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4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
(412) 624-4141
Principal Investigator: Andrew Evans, MD
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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620 John Paul Jones Cir
Portsmouth, Virginia 23708
(757) 953-5008
Principal Investigator: Christopher Smith, MD
Naval Medical Center - Portsmouth Naval Medical Center Portsmouth, Virginia has proudly served the military...
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4502 Medical Drive
San Antonio, Texas 78284
(210) 567-7000
Principal Investigator: Animesh Agarwal, MD
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
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34800 Bob Wilson Dr,
San Diego, California 92134
(619) 532-6400
Principal Investigator: James E Toledano, MD, MC, USN
Naval Medical Center - San Diego We are the largest and most comprehensive military healthcare...
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Asheville, North Carolina 28801
Principal Investigator: Harold Frisch, MD
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Baltimore, Maryland 21201
Principal Investigator: Bob O' Toole, MD
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8901 Rockville Pike
Bethesda, Maryland 20889
(301) 295-4000
Principal Investigator: Wade Gordon, MD
Walter Reed National Military Medical Center The Walter Reed National Military Medical Center is one...
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Boston, Massachusetts 02118
Principal Investigator: Paul Tornetta, MD
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2500 Metrohealth Dr
Cleveland, Ohio 44109
(216) 778-7800
Principal Investigator: Heather A Vallier, MD
MetroHealth Med Ctr The MetroHealth System is one of the largest, most comprehensive health care...
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Danville, Pennsylvania 17822
Principal Investigator: Michael Suk, MD
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Denver, Colorado 80204
Principal Investigator: David J Hak, MD, MBA
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415 East Yandell Drive
El Paso, Texas 79905
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Fort Sam Houston, Texas 78234
Principal Investigator: Daniel Stinner, MD
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Hershey, Pennsylvania 17033
Principal Investigator: J Spence Reid, MD
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Houston, Texas 77030
Principal Investigator: Joshua Gary, MD
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650 Eskenazi Avenue
Indianapolis, Indiana 46202
Principal Investigator: Brian Mullis, MD
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Indianapolis, Indiana 46202
Principal Investigator: Todd McKinley, MD
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Indianapolis, Indiana
Principal Investigator: Renn Crichlow, MD
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Madison, Wisconsin 53792
(608) 263-2400
Principal Investigator: Christopher Doro, MD
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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Miami, Florida 33101
Principal Investigator: Gregory A Zych, DO
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701 Park Ave
Minneapolis, Minnesota 55415
(612) 873-3000
Principal Investigator: Andrew Schmidt, MD
Hennepin County Medical Center - Minneapolis Hennepin Healthcare System, Inc. operates Hennepin County Medical Center...
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320 E North Ave
Pittsburgh, Pennsylvania 15212
(412) 359-3131
Principal Investigator: Gregory Altman, MD
Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
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321 South Newstead Avenue
Saint Louis, Missouri 63110
Principal Investigator: Lisa Cannada, MD
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640 Jackson Street
Saint Paul, Minnesota 55101
651-254-3456
Principal Investigator: Paul Lafferty, MD
Regions Hospital Established in 1872, Regions Hospital is a private, not-for-profit organization. The hospital provides...
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San Francisco, California 94115
Principal Investigator: Theodore Miclau, MD
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Tampa, Florida 33606
Principal Investigator: Anjan Shah, MD
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1 Medical Center Blvd
Winston-Salem, North Carolina 27103
(336) 716-2011
Principal Investigator: Eben Carroll, MD
Wake Forest University Baptist Medical Center Welcome to Wake Forest Baptist Medical Center, a fully...
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