Rib Fixation for Clinically Severe Rib Fractures From Trauma (SOFRIB)

May 7, 2022 updated by: Darwin Ang

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
236

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Florida
      • Fort Pierce, Florida, United States, 34950
        • Recruiting
        • Lawnwood Regional Medical Center
        • Contact:
          • Jamie Santos, RN
      • Fort Walton Beach, Florida, United States, 32547
        • Active, not recruiting
        • Fort Walton Beach Medical Center
      • Kissimmee, Florida, United States, 34741
        • Active, not recruiting
        • Osceola Regional Medical Center
      • Miami, Florida, United States, 33175
        • Recruiting
        • Kendall Regional Medical Center
        • Contact:
          • Mark McKenney, MD
      • Ocala, Florida, United States, 34471
        • Recruiting
        • Ocala Regional Medical Center - Health Trauma
        • Contact:
        • Principal Investigator:
          • Darwin Ang, MD
      • Orange Park, Florida, United States, 32073
        • Active, not recruiting
        • Orange Park Medical Center
      • Sanford, Florida, United States, 32771
    • Missouri
      • Kansas City, Missouri, United States, 64132
        • Active, not recruiting
        • Research Medical Center
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Recruiting
        • Grand Strand Regional Medical Center
        • Contact:
          • Heather Rhodes, RN
    • Virginia
      • Richmond, Virginia, United States, 23225
        • Recruiting
        • Chippenham Johnston-Willis Hospital
        • Contact:
          • Stanley Kurek, DO

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Rib Fixation System
This group of subjects will receive a surgical rib plating procedure after trauma
Device: Rib Fixation System
This intervention involves a surgical procedure to affix rib plates to broken ribs
Other Names:
  • DePuySynthes MatrixRIB Contoured Rib Implants
No Intervention: Critical Care and Pain Control
This group will receive critical care and pain control after trauma

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
ICU Length of Stay
Time Frame: measured through study completion, up to 2 years
length of stay in days
measured through study completion, up to 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quality of Life, as determined by SF-36 survey
Time Frame: measured at 1 week, 3 months, 6 months post-intervention
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
Time Frame: measured monthly through course of study, up to 2 years
based on classification as complication of rib trauma treatment
measured monthly through course of study, up to 2 years
Total cost of treatments
Time Frame: measured through study completion, up to 2 years
measured based on total costs during length of hospital stay
measured through study completion, up to 2 years

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Complication Rates
Time Frame: measured at 1 week, 3 months, 6 months
including, but not limited to, pneumonia, urinary tract infection, arrhythmia, sepsis, reintubation, wound infection
measured at 1 week, 3 months, 6 months
Pain Control documented by the Functional Pain Scale
Time Frame: measured before and after surgery and at time of discharge, through study completion, up to 2 years
measured using the Functional Pain Scale
measured before and after surgery and at time of discharge, through study completion, up to 2 years
Ventilator/Ventilator Free Days
Time Frame: measured through study completion, up to 2 years
measured in days on or off ventilation, based on length of stay in hospital
measured through study completion, up to 2 years
Narcotic usage
Time Frame: measured at 1 week, 3 months, 6 months
converted to units of morphine
measured at 1 week, 3 months, 6 months
Hospital length of stay
Time Frame: measured through study completion, up to 2 years
measured in days
measured through study completion, up to 2 years
Pulmonary Function
Time Frame: measured at discharge, 3 months, and 6 months, through study completion, up to 2 years
as measured by FVC (forced vital capacity), FEV1, and TLC by spirometry
measured at discharge, 3 months, and 6 months, through study completion, up to 2 years
Time to wean from ventilator
Time Frame: measured through study completion, up to 2 years
measured in days
measured through study completion, up to 2 years
Tracheostomy rates
Time Frame: measured at 1 week, 3 months, 6 months
overall rate of tracheostomy in population
measured at 1 week, 3 months, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Darwin Ang

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Darwin Ang, MD, HCA Trauma Network

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 30, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 3, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 10, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SCRI HEOR_02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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