Rib FractureSOFRIBNCT02595593
Rib Fixation for Clinically Severe Rib Fractures From Trauma
A study testing Rib Fixation System in people with Rib Fracture and Flail Chest, run by Darwin Ang at 10 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Rib Fracture, Flail Chest
- What is being tested?
- Rib Fixation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 10 sitesUnited States
- Study dates
- Apr 2015to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Penetrating chest trauma
- Chronic opioid dependence
- Fractures less than 3cm from vertebral spine
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites, 6 recruiting
- Active, not recruiting
Fort Walton Beach Medical Center
Fort Walton Beach, Florida, 32547
- Recruiting
Lawnwood Regional Medical Center
Ft. Pierce, Florida, 34950
Jamie Santos, RN
- Active, not recruiting
Research Medical Center
Kansas City, Missouri, 64132
- Active, not recruiting
Osceola Regional Medical Center
Kissimmee, Florida, 34741
- Recruiting
Kendall Regional Medical Center
Miami, Florida, 33175
Mark McKenney, MD
- Recruiting
Grand Strand Regional Medical Center
Myrtle Beach, South Carolina, 29572
Heather Rhodes, RN
- Recruiting
Ocala Regional Medical Center - Health Trauma
Ocala, Florida, 34471
Donna A Nayduch, RN, MSN, 352-401-1022, dnayduch@cfl.rr.com
Darwin Ang, MD
- Active, not recruiting
Orange Park Medical Center
Orange Park, Florida, 32073
- Recruiting
Chippenham Johnston-Willis Hospital
Richmond, Virginia, 23225
Stanley Kurek, DO
- Recruiting
Central Florida Regional Hospital
Sanford, Florida, 32771
William Campbell, RN, william.campbell5@hcahealthcare.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Rib Fracture, Flail Chest
- Being tested
- Rib Fixation System
- Keywords
- Trauma, Rib Plate, Rib Fixation
- Medical subject headings
- Rib Fractures, Flail Chest, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rib Fixation SystemDevice
Also called DePuySynthes MatrixRIB Contoured Rib Implants
This intervention involves a surgical procedure to affix rib plates to broken ribs
| Study group | Role | What they receive |
|---|---|---|
| Rib Fixation System | Active comparator | This group of subjects will receive a surgical rib plating procedure after trauma Receives: Device: Rib Fixation System |
| Critical Care and Pain Control | No intervention | This group will receive critical care and pain control after trauma |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU Length of Stay
length of stay in days
Measured: measured through study completion, up to 2 years
Secondary outcomes (3)
Quality of Life, as determined by SF-36 survey
measured at 3 different time points post-hospital stay
Measured: 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: 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: measured through study completion, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study startApr 2015
- Primary completionJan 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rib FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 236 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Darwin Ang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Darwin Ang, SCRI Development Innovations, LLC
- Investigators
- Darwin Ang, MD, Principal investigator, HCA Trauma Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02595593
- Sponsor's protocol ID
- SCRI HEOR_02
- Acronym
- SOFRIB
- Status last verified
- May 2022
- First submitted
- 30 Apr 2015
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective Randomized Trial on the Intervention of Rib Fixation for Clinically Severe Rib Fractures From Trauma
- ClinicalTrials.gov ID
- NCT02595593
- Acronym / sponsor ID
- SOFRIB / SCRI HEOR_02
- Conditions
- Rib Fracture, Flail Chest
- Keywords
- Trauma, Rib Plate, Rib Fixation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 236 participants (estimated)
- Lead sponsor
- Darwin AngUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 3 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rib Fixation System | Active comparator | Device: Rib Fixation SystemThis group of subjects will receive a surgical rib plating procedure after trauma |
| Critical Care and Pain Control | No intervention | –This group will receive critical care and pain control after trauma |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rib Fixation SystemAlso: DePuySynthes MatrixRIB Contoured Rib ImplantsThis intervention involves a surgical procedure to affix rib plates to broken ribs | Device | Rib Fixation System |
Primary outcome
ICU Length of Stay
Time frame: measured through study completion, up to 2 years
length of stay in days
3 secondary outcomes
Quality of Life, as determined by SF-36 survey
Time frame: 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
Total cost of treatments
Time frame: measured through study completion, up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darwin Ang, MD principal investigator
HCA Trauma Network
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rib Fixation System in people with Rib Fracture and Flail Chest, run by Darwin Ang at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Donna Nayduch, RN, MSN (352-401-1022, donna.nayduch@hcahealthcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU Length of Stay (time frame: measured through study completion, up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2022.