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Summary

for people ages 18–64 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

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.

Official Title

A Prospective Randomized Trial to Assess Fixation Strategies for Severe Open Tibia Fractures:Modern Ring External Fixators Versus Internal Fixation

Details

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.

Keywords

Severe Open Fractures of the Tibia (Shin) Bone External ring fixation internal fixation traumatic tibia fracture

Eligibility

You can join if…

Open to people ages 18–64

  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.

You CAN'T join if...

  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

Locations

  • Naval Medical Center San Diego accepting new patients
    San Diego, California, 92134, United States
  • Denver Health and Hospital Authority accepting new patients
    Denver, Colorado, 80204, United States
  • Texas Tech University Health Sciences Center terminated
    El Paso, Texas, 79905, United States
  • University of Texas Health Science Center, San Antonio accepting new patients
    San Antonio, Texas, 78229, United States
  • San Antonio Military Medical Center accepting new patients
    Fort Sam Houston, Texas, 78234-6315, United States
  • University of Texas Southwestern Medical Center accepting new patients
    Dallas, Texas, 75390, United States
  • UT Health: The University of Texas Health Science Center at Houston Medical School accepting new patients
    Houston, Texas, 77030, United States
  • Hennepin County Medical Center / Minneapolis accepting new patients
    Minneapolis, Minnesota, 55415, United States
  • Regions Hospital accepting new patients
    Saint Paul, Minnesota, 55101, United States
  • University of Iowa Hospitals & Clinics withdrawn
    Iowa City, Iowa, 52242, United States
  • St. Louis Medical Center accepting new patients
    Saint Louis, Missouri, 63110, United States
  • University of Wisconsin accepting new patients
    Madison, Wisconsin, 53705, United States
  • University of Mississippi Medical Center accepting new patients
    Jackson, Mississippi, 39216, United States
  • St Vincent Hospital accepting new patients
    Indianapolis, Indiana, 46260, United States
  • Vanderbilt University Medical Center accepting new patients
    Nashville, Tennessee, 37232, United States
  • Eskenazi Health accepting new patients
    Indianapolis, Indiana, 46202, United States
  • OrthoIndy / Methodist Hospital accepting new patients
    Indianapolis, Indiana, 46202, United States
  • Orthopaedic Associates of Michigan, Spectrum Health withdrawn
    Grand Rapids, Michigan, 49503, United States
  • University of Alabama at Birmingham accepting new patients
    Birmingham, Alabama, 35294, United States
  • MetroHealth Medical Center accepting new patients
    Cleveland, Ohio, 44109, United States
  • Mission Hospital accepting new patients
    Asheville, North Carolina, 28801, United States
  • Allegheny General Hospital accepting new patients
    Pittsburgh, Pennsylvania, 15212, United States
  • University of Pittsburgh accepting new patients
    Pittsburgh, Pennsylvania, 15213, United States
  • Carolinas Medical Center accepting new patients
    Charlotte, North Carolina, 28232, United States
  • Wake Forest University Baptist Medical Center accepting new patients
    Winston-Salem, North Carolina, 27157-1070, United States
  • Florida Orthopaedic Institute, St. Joseph's Hospital withdrawn
    Tampa, Florida, 33607, United States
  • Florida Orthopaedic Institute, Tampa General Hospital accepting new patients
    Tampa, Florida, 33606, United States
  • Duke University Hospital withdrawn
    Durham, North Carolina, 27710, United States
  • Orlando Regional Medical Center terminated
    Orlando, Florida, 32806, United States
  • Walter Reed National Military Medical Center accepting new patients
    Bethesda, Maryland, 20889, United States
  • Geisinger Health System accepting new patients
    Danville, Pennsylvania, 17822, United States
  • Penn State University M.S. Hershey Medical Center accepting new patients
    Hershey, Pennsylvania, 17033, United States
  • University of Maryland, R Adams Cowley Shock Trauma Center accepting new patients
    Baltimore, Maryland, 21201, United States
  • Naval Medical Center Portsmouth accepting new patients
    Portsmouth, Virginia, 23708, United States
  • University of Miami Ryder Trauma Center accepting new patients
    Miami, Florida, 33101, United States
  • Boston Medical Center accepting new patients
    Boston, Massachusetts, 02118, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Major Extremity Trauma Research Consortium
ID
NCT01494519
Phase
Phase 3
Lead Scientist
Theodore Miclau
Study Type
Interventional
Last Updated
April 1, 2017
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