Rib Fixation for Clinically Severe Rib Fractures From Trauma
NCT ID: NCT02595593
Last Updated: 2022-05-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
236 participants
INTERVENTIONAL
2015-04-30
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Rib Fixation System
This group of subjects will receive a surgical rib plating procedure after trauma
Rib Fixation System
This intervention involves a surgical procedure to affix rib plates to broken ribs
Critical Care and Pain Control
This group will receive critical care and pain control after trauma
No interventions assigned to this group
Interventions
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Rib Fixation System
This intervention involves a surgical procedure to affix rib plates to broken ribs
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
90 Years
ALL
No
Sponsors
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Darwin Ang
OTHER
Responsible Party
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Darwin Ang
Director, Medical Trauma Services, Ocala Health Trauma
Principal Investigators
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Darwin Ang, MD
Role: PRINCIPAL_INVESTIGATOR
HCA Trauma Network
Locations
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Fort Walton Beach Medical Center
Fort Walton Beach, Florida, United States
Lawnwood Regional Medical Center
Ft. Pierce, Florida, United States
Osceola Regional Medical Center
Kissimmee, Florida, United States
Kendall Regional Medical Center
Miami, Florida, United States
Ocala Regional Medical Center - Health Trauma
Ocala, Florida, United States
Orange Park Medical Center
Orange Park, Florida, United States
Central Florida Regional Hospital
Sanford, Florida, United States
Research Medical Center
Kansas City, Missouri, United States
Grand Strand Regional Medical Center
Myrtle Beach, South Carolina, United States
Chippenham Johnston-Willis Hospital
Richmond, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Jamie Santos, RN
Role: primary
Mark McKenney, MD
Role: primary
Heather Rhodes, RN
Role: primary
Stanley Kurek, DO
Role: primary
Other Identifiers
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SCRI HEOR_02
Identifier Type: -
Identifier Source: org_study_id
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