Rib FracturesNCT00926991
Chest Wall Repair of Rib Fractures After Trauma
An observational study of Rib Fractures, run by Vanderbilt University at 1 site in United States.
Trial summary
This is a prospective, observational trial of 50 patients who have multiple, severe rib fractures following trauma. The investigators will follow their hospital stay for outcomes (infections, length of stay and medical care) as well as their early post-hospital course. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rib Fractures
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Sep 2010
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Vanderbilt University Trauma Center.
Who may be able to join
- Subjects must be at least >18 years of age
- Subjects must have one of the following clinical indications:
- >3 rib flail segments with paradoxical chest wall movement
- Non-repair of defect may result in pulmonary hernia
- Minimal associated injuries
- Severely displaced fractures are significantly impeding lung expansion.
- Failure of narcotics or epidural pain catheter to control pain
Who cannot join
- Significant pulmonary contusion
- Significant brain injury (AIS 4 and/or ICP monitoring)
- Severe associated injuries which, in the opinion of the surgeon will preclude operative chest wall stabilization
- Subjects not expected to survive the 90-day follow-up period
- Known pregnancy
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Chest Wall Stabilization for Traumatic Chest Wall Injuries: An Observational Study
This is a prospective, observational trial of 50 patients who have multiple, severe rib fractures following trauma. The investigators will follow their hospital stay for outcomes (infections, length of stay and medical care) as well as their early post-hospital course.
Read the detailed description
Hypothesis:
Rib fracture repair utilizing open reduction and internal fixation with commercially available rib plating systems improves outcomes (i.e., infectious complications), decreases hospital stay and mortality.
Study Design:
This is a prospective, observational study of 50 patients who, due to their injury pattern, are operative candidates for open reduction and internal fixation with commercial available rib plating systems for one of the following indications:
- Flail chest with/without failure to wean from the ventilator
- Significantly displaced rib fractures with/without lung impalement
- Symptomatic multiple rib fractures - Failure of pain control
Outcome measures to be evaluated include:
- Hospital Mortality
- Ventilator free days
- Need for tracheotomy
- Infectious Complications (pneumonia, bacteremia, UTI, empyema)
- Hospital \& ICU Days
- Disposition following discharge
- Conditions
- Rib Fractures
- Being tested
- No intervention
- Medical subject headings
- Rib Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention; observation only
| Study group | Role | What they receive |
|---|---|---|
| traumatic rib fractures | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain scales
Measured: daily
ventilator requirement
Measured: daily
hospital days
Measured: discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2009 (estimated)
- Study startAug 2009
- Primary completionAug 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rib FracturesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Investigators
- Jose J Diaz, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00926991
- Sponsor's protocol ID
- Acute chest wall injuries
- Status last verified
- Mar 2011
- First submitted
- 22 Jun 2009
- Last updated
- 22 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chest Wall Stabilization for Traumatic Chest Wall Injuries: An Observational Study
- ClinicalTrials.gov ID
- NCT00926991
- Acronym / sponsor ID
- Acute chest wall injuries
- Conditions
- Rib Fractures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 24 Jun 2009 (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 prospective, observational trial of 50 patients who have multiple, severe rib fractures following trauma. The investigators will follow their hospital stay for outcomes (infections, length of stay and medical care) as well as their early post-hospital course.
Detailed description
Hypothesis:
Rib fracture repair utilizing open reduction and internal fixation with commercially available rib plating systems improves outcomes (i.e., infectious complications), decreases hospital stay and mortality.
Study Design:
This is a prospective, observational study of 50 patients who, due to their injury pattern, are operative candidates for open reduction and internal fixation with commercial available rib plating systems for one of the following indications:
- Flail chest with/without failure to wean from the ventilator
- Significantly displaced rib fractures with/without lung impalement
- Symptomatic multiple rib fractures - Failure of pain control
Outcome measures to be evaluated include:
- Hospital Mortality
- Ventilator free days
- Need for tracheotomy
- Infectious Complications (pneumonia, bacteremia, UTI, empyema)
- Hospital \& ICU Days
- Disposition following discharge
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| traumatic rib fractures | – | Other: No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Vanderbilt University Trauma Center.
Key inclusion criteria (7 listed)
- Subjects must be at least >18 years of age
- Subjects must have one of the following clinical indications:
- >3 rib flail segments with paradoxical chest wall movement
- Non-repair of defect may result in pulmonary hernia
- Minimal associated injuries
Key exclusion criteria (6 listed)
- Significant pulmonary contusion
- Significant brain injury (AIS 4 and/or ICP monitoring)
- Severe associated injuries which, in the opinion of the surgeon will preclude operative chest wall stabilization
- Subjects not expected to survive the 90-day follow-up period
- Known pregnancy
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 |
|---|---|---|
| No interventionNo intervention; observation only | Other | traumatic rib fractures |
Primary outcome
pain scales
Time frame: daily
ventilator requirement
Time frame: daily
hospital days
Time frame: discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2011.
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GNRI and PNI for Predicting Short-Term Outcomes in Older Adults With Multiple Rib Fractures
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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.
Jose J Diaz, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rib Fractures, run by Vanderbilt University at 1 site 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 6 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: finished, as of the sponsor's last update on 22 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain scales (time frame: daily). The study lists 3 primary outcomes in all. 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 22 Mar 2011.