Rib Fixation for Clinically Severe Rib Fractures From Trauma

Last updated: May 7, 2022
Sponsor: Darwin Ang
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chest Trauma

Treatment

N/A

Clinical Study ID

NCT02595593
SCRI HEOR_02
  • Ages 18-90
  • All Genders

Study Summary

This is a multicenter randomized study investigating the differences in clinical outcomes of patients between two standard of care pathways for rib trauma: patients who receive rib fixation versus patients who receive modern critical care and pain control after sustaining clinically significant rib fractures from trauma.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Flail chest, defined as 3 or more consecutive ribs fractured in more than one place
  • Pain and disability of an FPS (Functional Pain Scale) rating of 3 or higher
  • Deformity and Defect
  • Non-Union
  • Thoracotomy for other indications
  • 3 or more rib fractures with rib displacement of more than 1 rib cortical diameter
  • Failure to wean from ventilator

Exclusion

Exclusion Criteria:

  • Active bacteremia
  • Active shock
  • Severe Traumatic Brain Injury with GCS < 8
  • Age 17 years or less or age greater than 90 years old
  • Chronic pulmonary disease requiring home oxygenation
  • Acute Respiratory Distress Syndrome
  • Penetrating chest trauma
  • Chronic opioid dependence
  • Fractures less than 3cm from vertebral spine

Study Design

Total Participants: 236
Study Start date:
April 01, 2015
Estimated Completion Date:
December 31, 2023

Study Description

This study will compare the outcomes of patients between two standard of care pathways for rib trauma: those who have their ribs plated versus those who are managed by modern critical care and pain control. A study nurse (project) coordinator will identify subjects based on inclusion and exclusion criteria, then obtain consent for each of these patients prior to randomization. Randomization will be decided by a web-based computer program, accessible to the project coordinator. Although this randomization occurs, the study itself is purely observational, as the intervention is currently standard of care. None of the subjects or study group members will be blinded since it is not possible to disguise the intervention. Patients will be evaluated and a survey will be administered at set post-intervention intervals to determine endpoints and quality of life when data analysis will also take place.

Connect with a study center

  • Blake Medical Center

    Bradenton, Florida 34209
    United States

    Site Not Available

  • Lawnwood Regional Medical Center

    Fort Pierce, Florida 34950
    United States

    Active - Recruiting

  • Fort Walton Beach Medical Center

    Fort Walton Beach, Florida 32547
    United States

    Site Not Available

  • Bayonet Point Regional Medical Center

    Hudson, Florida 34667
    United States

    Site Not Available

  • Osceola Regional Medical Center

    Kissimmee, Florida 34741
    United States

    Site Not Available

  • Kendall Regional Medical Center

    Miami, Florida 33175
    United States

    Active - Recruiting

  • Ocala Regional Medical Center - Health Trauma

    Ocala, Florida 34471
    United States

    Active - Recruiting

  • Orange Park Medical Center

    Orange Park, Florida 32073
    United States

    Site Not Available

  • Central Florida Regional Hospital

    Sanford, Florida 32771
    United States

    Active - Recruiting

  • Research Medical Center

    Kansas City, Missouri 64132
    United States

    Site Not Available

  • Grand Strand Regional Medical Center

    Myrtle Beach, South Carolina 29572
    United States

    Active - Recruiting

  • Chippenham Johnston-Willis Hospital

    Richmond, Virginia 23225
    United States

    Active - Recruiting

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