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

Primary Purpose

Rib Fracture, Flail Chest

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Rib Fixation System
Sponsored by
Darwin Ang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Rib Fracture focused on measuring Trauma, Rib Plate, Rib Fixation

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lawnwood Regional Medical CenterRecruiting
  • Fort Walton Beach Medical Center
  • Osceola Regional Medical Center
  • Kendall Regional Medical CenterRecruiting
  • Ocala Regional Medical Center - Health TraumaRecruiting
  • Orange Park Medical Center
  • Central Florida Regional HospitalRecruiting
  • Research Medical Center
  • Grand Strand Regional Medical CenterRecruiting
  • Chippenham Johnston-Willis HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Rib Fixation System

Critical Care and Pain Control

Arm Description

This group of subjects will receive a surgical rib plating procedure after trauma

This group will receive critical care and pain control after trauma

Outcomes

Primary Outcome Measures

ICU Length of Stay
length of stay in days

Secondary Outcome Measures

Quality of Life, as determined by SF-36 survey
measured at 3 different time points post-hospital stay
Number of participants with pneumonia as defined by the Centers for Disease Control
based on classification as complication of rib trauma treatment
Total cost of treatments
measured based on total costs during length of hospital stay

Full Information

First Posted
April 30, 2015
Last Updated
May 7, 2022
Sponsor
Darwin Ang
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1. Study Identification

Unique Protocol Identification Number
NCT02595593
Brief Title
Rib Fixation for Clinically Severe Rib Fractures From Trauma
Acronym
SOFRIB
Official Title
A Multicenter Prospective Randomized Trial on the Intervention of Rib Fixation for Clinically Severe Rib Fractures From Trauma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 2015 (Actual)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Darwin Ang

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rib Fracture, Flail Chest
Keywords
Trauma, Rib Plate, Rib Fixation

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
236 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rib Fixation System
Arm Type
Active Comparator
Arm Description
This group of subjects will receive a surgical rib plating procedure after trauma
Arm Title
Critical Care and Pain Control
Arm Type
No Intervention
Arm Description
This group will receive critical care and pain control after trauma
Intervention Type
Device
Intervention Name(s)
Rib Fixation System
Other Intervention Name(s)
DePuySynthes MatrixRIB Contoured Rib Implants
Intervention Description
This intervention involves a surgical procedure to affix rib plates to broken ribs
Primary Outcome Measure Information:
Title
ICU Length of Stay
Description
length of stay in days
Time Frame
measured through study completion, up to 2 years
Secondary Outcome Measure Information:
Title
Quality of Life, as determined by SF-36 survey
Description
measured at 3 different time points post-hospital stay
Time Frame
measured at 1 week, 3 months, 6 months post-intervention
Title
Number of participants with pneumonia as defined by the Centers for Disease Control
Description
based on classification as complication of rib trauma treatment
Time Frame
measured monthly through course of study, up to 2 years
Title
Total cost of treatments
Description
measured based on total costs during length of hospital stay
Time Frame
measured through study completion, up to 2 years
Other Pre-specified Outcome Measures:
Title
Complication Rates
Description
including, but not limited to, pneumonia, urinary tract infection, arrhythmia, sepsis, reintubation, wound infection
Time Frame
measured at 1 week, 3 months, 6 months
Title
Pain Control documented by the Functional Pain Scale
Description
measured using the Functional Pain Scale
Time Frame
measured before and after surgery and at time of discharge, through study completion, up to 2 years
Title
Ventilator/Ventilator Free Days
Description
measured in days on or off ventilation, based on length of stay in hospital
Time Frame
measured through study completion, up to 2 years
Title
Narcotic usage
Description
converted to units of morphine
Time Frame
measured at 1 week, 3 months, 6 months
Title
Hospital length of stay
Description
measured in days
Time Frame
measured through study completion, up to 2 years
Title
Pulmonary Function
Description
as measured by FVC (forced vital capacity), FEV1, and TLC by spirometry
Time Frame
measured at discharge, 3 months, and 6 months, through study completion, up to 2 years
Title
Time to wean from ventilator
Description
measured in days
Time Frame
measured through study completion, up to 2 years
Title
Tracheostomy rates
Description
overall rate of tracheostomy in population
Time Frame
measured at 1 week, 3 months, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Donna Nayduch, RN, MSN
Phone
352-401-1022
Email
donna.nayduch@hcahealthcare.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darwin Ang, MD
Organizational Affiliation
HCA Trauma Network
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lawnwood Regional Medical Center
City
Fort Pierce
State/Province
Florida
ZIP/Postal Code
34950
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jamie Santos, RN
Facility Name
Fort Walton Beach Medical Center
City
Fort Walton Beach
State/Province
Florida
ZIP/Postal Code
32547
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Osceola Regional Medical Center
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Kendall Regional Medical Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark McKenney, MD
Facility Name
Ocala Regional Medical Center - Health Trauma
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donna A Nayduch, RN, MSN
Phone
352-401-1022
Email
dnayduch@cfl.rr.com
First Name & Middle Initial & Last Name & Degree
Darwin Ang, MD
Facility Name
Orange Park Medical Center
City
Orange Park
State/Province
Florida
ZIP/Postal Code
32073
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Central Florida Regional Hospital
City
Sanford
State/Province
Florida
ZIP/Postal Code
32771
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Campbell, RN
Email
william.campbell5@hcahealthcare.com
Facility Name
Research Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Grand Strand Regional Medical Center
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heather Rhodes, RN
Facility Name
Chippenham Johnston-Willis Hospital
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23225
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stanley Kurek, DO

12. IPD Sharing Statement

Learn more about this trial

Rib Fixation for Clinically Severe Rib Fractures From Trauma

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