Clinical trial NCT02595593: Rib Fixation for Clinically Severe Rib Fractures From Trauma
Official title: A Multicenter Prospective Randomized Trial on the Intervention of Rib Fixation for Clinically Severe Rib Fractures From Trauma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rib Fracture
Flail Chest
Keywords: Trauma
Rib Plate
Rib Fixation
Lead sponsor: SCRI Development Innovations, LLC
Sponsor class: OTHER
First posted: 2015-11-03
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: ICU Length of Stay
timeFrame: measured through study completion, up to 2 years
Secondary outcomes:
measure: Quality of Life, as determined by SF-36 survey
timeFrame: measured at 1 week, 3 months, 6 months post-intervention
measure: Number of participants with pneumonia as defined by the Centers for Disease Control
timeFrame: measured monthly through course of study, up to 2 years
measure: Total cost of treatments
timeFrame: measured through study completion, up to 2 years
Other outcomes:
measure: Complication Rates
timeFrame: measured at 1 week, 3 months, 6 months
measure: Pain Control documented by the Functional Pain Scale
timeFrame: measured before and after surgery and at time of discharge, through study completion, up to 2 years
measure: Ventilator/Ventilator Free Days
timeFrame: measured through study completion, up to 2 years
measure: Narcotic usage
timeFrame: measured at 1 week, 3 months, 6 months
measure: Hospital length of stay
timeFrame: measured through study completion, up to 2 years
measure: Pulmonary Function
timeFrame: measured at discharge, 3 months, and 6 months, through study completion, up to 2 years
measure: Time to wean from ventilator
timeFrame: measured through study completion, up to 2 years
measure: Tracheostomy rates
timeFrame: measured at 1 week, 3 months, 6 months
Locations:
city: Fort Pierce
country: United States
facility: Lawnwood Regional Medical Center
state: Florida
city: Fort Walton Beach
country: United States
facility: Fort Walton Beach Medical Center
state: Florida
city: Kissimmee
country: United States
facility: Osceola Regional Medical Center
state: Florida
city: Miami
country: United States
facility: Kendall Regional Medical Center
state: Florida
city: Ocala
country: United States
facility: Ocala Regional Medical Center - Health Trauma
state: Florida
city: Orange Park
country: United States
facility: Orange Park Medical Center
state: Florida
city: Sanford
country: United States
facility: Central Florida Regional Hospital
state: Florida
city: Kansas City
country: United States
facility: Research Medical Center
state: Missouri
city: Myrtle Beach
country: United States
facility: Grand Strand Regional Medical Center
state: South Carolina
city: Richmond
country: United States
facility: Chippenham Johnston-Willis Hospital
state: Virginia
Study officials:
affiliation: HCA Trauma Network
name: Darwin Ang, MD
role: PRINCIPAL_INVESTIGATOR
References: