Rib Fixation for Clinically Severe Rib Fractures From Trauma



Status:Recruiting
Conditions:Hospital, Orthopedic
Therapuetic Areas:Orthopedics / Podiatry, Other
Healthy:No
Age Range:18 - 90
Updated:4/21/2016
Start Date:April 2015
End Date:October 2018
Contact:Donna Nayduch, RN, MSN
Email:donna.nayduch@hcahealthcare.com
Phone:352-401-1022

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A Multicenter Prospective Randomized Trial on the Intervention of Rib Fixation for Clinically Severe Rib Fractures From Trauma

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.

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.

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 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
We found this trial at
8
sites
Kissimmee, Florida 34741
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Bradenton, Florida 34209
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Bradenton, FL
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Fort Pierce, Florida 34950
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Fort Pierce, FL
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Hudson, FL
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2316 E Meyer Blvd
Kansas City, Missouri 64132
(816) 276-4000
Research Medical Center Research Medical Center offers hospital and health clinic services across three Kansas...
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Kansas City, MO
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Miami, Florida 33175
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Miami, FL
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Myrtle Beach, South Carolina 29572
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Myrtle Beach, SC
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Ocala, Florida 34471
Principal Investigator: Darwin Ang, MD
Phone: 352-401-1022
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Ocala, FL
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