Rib Fixation for Clinically Severe Rib Fractures From Trauma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Rib Fracture, Flail Chest

Intervention / Treatment
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* Device: Rib Fixation System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rib Fixation System<br>This group of subjects will receive a surgical rib plating procedure after trauma | Device: Rib Fixation System<br>* This intervention involves a surgical procedure to affix rib plates to broken ribs<br>* Other names: DePuySynthes MatrixRIB Contoured Rib Implants;|
| No Intervention: Critical Care and Pain Control<br>This group will receive critical care and pain control after trauma | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU Length of Stay | length of stay in days | measured through study completion, up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life, as determined by SF-36 survey | measured at 3 different time points post-hospital stay | measured at 1 week, 3 months, 6 months post-intervention | 
| Number of participants with pneumonia as defined by the Centers for Disease Control | based on classification as complication of rib trauma treatment | measured monthly through course of study, up to 2 years | 
| Total cost of treatments | measured based on total costs during length of hospital stay | measured through study completion, up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Trauma, Rib Plate, Rib Fixation