Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
50 participants
OBSERVATIONAL
2009-08-31
2010-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Rib Fixation for Clinically Severe Rib Fractures From Trauma
NCT02595593
Trial of Operative Fixation of Fractured Ribs in Patients With Flail Chest
NCT00298259
Prospective Follow up of Minimally Invasive Chest Wall Surgery After Trauma
NCT04710602
Surgical Stabilization for Rib Fractures
NCT04081233
MatrixRIB Implants for Surgical Stabilization of Flail Chest Injuries: A Registry
NCT00810251
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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:
1. Flail chest with/without failure to wean from the ventilator
2. Significantly displaced rib fractures with/without lung impalement
3. Symptomatic multiple rib fractures - Failure of pain control
Outcome measures to be evaluated include:
1. Hospital Mortality
2. Ventilator free days
3. Need for tracheotomy
4. Infectious Complications (pneumonia, bacteremia, UTI, empyema)
5. Hospital \& ICU Days
6. Disposition following discharge
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
traumatic rib fractures
No intervention
No intervention; observation only
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
No intervention
No intervention; observation only
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Vanderbilt University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Vanderbilt University Medical Center
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jose J Diaz, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Acute chest wall injuries
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.