Chest Wall Repair of Rib Fractures After Trauma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00926991
Recruitment Status : Completed
First Posted : June 24, 2009
Last Update Posted : March 22, 2011
Information provided by:
Vanderbilt University

Brief Summary:
This is a prospective, observational trial of 50 patients who have multiple, severe rib fractures following trauma. The investigators will follow their hospital stay for outcomes (infections, length of stay and medical care) as well as their early post-hospital course.

Condition or disease Intervention/treatment
Rib Fractures Other: No intervention

Detailed Description:


Rib fracture repair utilizing open reduction and internal fixation with commercially available rib plating systems improves outcomes (i.e., infectious complications), decreases hospital stay and mortality.

Study Design:

This is a prospective, observational study of 50 patients who, due to their injury pattern, are operative candidates for open reduction and internal fixation with commercial available rib plating systems for one of the following indications:

  1. Flail chest with/without failure to wean from the ventilator
  2. Significantly displaced rib fractures with/without lung impalement
  3. Symptomatic multiple rib fractures - Failure of pain control

Outcome measures to be evaluated include:

  1. Hospital Mortality
  2. Ventilator free days
  3. Need for tracheotomy
  4. Infectious Complications (pneumonia, bacteremia, UTI, empyema)
  5. Hospital & ICU Days
  6. Disposition following discharge

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Chest Wall Stabilization for Traumatic Chest Wall Injuries: An Observational Study
Study Start Date : August 2009
Actual Primary Completion Date : August 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
traumatic rib fractures Other: No intervention
No intervention; observation only

Primary Outcome Measures :
  1. pain scales [ Time Frame: daily ]
  2. ventilator requirement [ Time Frame: daily ]
  3. hospital days [ Time Frame: discharge ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Vanderbilt University Trauma Center.

Inclusion Criteria:

  • Subjects must be at least >18 years of age
  • Subjects must have one of the following clinical indications:
  • >3 rib flail segments with paradoxical chest wall movement
  • Non-repair of defect may result in pulmonary hernia
  • Minimal associated injuries
  • Severely displaced fractures are significantly impeding lung expansion.
  • Failure of narcotics or epidural pain catheter to control pain

Exclusion Criteria:

  • Significant pulmonary contusion
  • Significant brain injury (AIS 4 and/or ICP monitoring)
  • Severe associated injuries which, in the opinion of the surgeon will preclude operative chest wall stabilization
  • Subjects not expected to survive the 90-day follow-up period
  • Known pregnancy
  • Prisoners

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00926991

United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Principal Investigator: Jose J Diaz, MD Vanderbilt University Medical Center

Responsible Party: Jose J. Diaz, Jr., MD, Vanderbilt University Medical Center Identifier: NCT00926991     History of Changes
Other Study ID Numbers: Acute chest wall injuries
First Posted: June 24, 2009    Key Record Dates
Last Update Posted: March 22, 2011
Last Verified: March 2011

Additional relevant MeSH terms:
Fractures, Bone
Rib Fractures
Wounds and Injuries
Thoracic Injuries