Rib FractureNCT02487264
Analysis of the Status, Treatment and Outcomes of Rib Fractures
An observational study of Rib Fracture and Trauma, run by Milton S. Hershey Medical Center.
Trial summary
A retrospective analysis of all patient presenting with multiple rib fractures to the emergency room of Penn State Hershey Medical Center between 2010-2012. Patient demographics, cause of fracture, outcomes, chronic medical conditions, vital signs, length of stay, pain levels and treatment, and sequelae will be… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Rib Fracture, Trauma
- How many people
- 921 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to 14 Dec 2017
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients presenting during 2010-2012 with multiple rib fractures to PSHMC emergency department
Who may be able to join
- must have above and be notated in our medical record
Who cannot join
- missing data
About this study
A retrospective analysis of all patient presenting with multiple rib fractures to the emergency room of Penn State Hershey Medical Center between 2010-2012. Patient demographics, cause of fracture, outcomes, chronic medical conditions, vital signs, length of stay, pain levels and treatment, and sequelae will be recorded and analyzed.
Read the detailed description
This is a retrospective chart review with follow-up phone calls.
The initial part of the study will be a retrospective chart review. For this chart review study, the following data elements will be entered for each participant.
The investigators will perform a retrospective study of patients who have been treated for rib fractures at Penn State Hershey Medical Center (PSHMC). The time period of review will be 1/10/10 - 1/10/12 until 1500 cases have been reviewed. Data collected will be:
- Patient Medical Record Number (MRN)
- Name
- Phone number
- length of stay (admit and discharge date)
- Number of rib fractures per patient
- Cause of rib fracture
- Characteristics of the fracture (unilateral versus bilateral and multiple versus single)
- Pain management used for the rib fracture including pain interventions, medications and all pain scores
- Complications attributable to the rib fracture, including:
- Shortness of Breath (SOB)
- Hemothorax,
- Pneumothorax
- Flail chest
- Intubation required
- Mechanical ventilation required
- Opioids required for pain
- Chest tube placement required
- Sequelae of rib fracture, including:
- Acute Respiratory Deficiency Syndrome (ARDS)
- Pneumonia
- Death
- chronic pain
- delayed subclavian vessel thrombosis
- aortic aneurysm
- tracheobronchial fistula
- thoracic outlet syndrome
- Horner's syndrome
- Clinical history of
- Rib fractures
- Other fractures
- Osteoporosis
- Chronic Obstructive Pulmonary Disease (COPD)
- Cancer
- Myocardial Infarction (MI) / Coronary Artery Disease (CAD)
- Arthritis
- Parkinson's disease
- Patient characteristics:
- Age
- Gender
- Race
- Body Mass Index (BMI)
- Alcohol use
- Smoking status
- Marital status
- Education
- Initial blood pressure
7.2.2 Follow-up phone calls
The investigators will then attempt to call the patients for follow-up information using a summary explanation of research phone script to obtain the following information:
- pain score
- quality of life via the EuroQol's quality of life survey :EQ-5D-3L questionnaire
- pain meds
- Conditions
- Rib Fracture, Trauma
- Medical subject headings
- Rib Fractures, Wounds and Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
Types and treatment of Rib Fractures
- Characteristics of the fracture (unilateral versus bilateral and multiple versus single)
- Pain management used for the rib fracture including pain interventions, medications and all pain scores
Measured: Past 4 years
Secondary outcomes (4)
sequelae and complications from rib fractures
sequelae and complications in patients presenting with rib fractures: •Complications attributable to the rib fracture, including:
- Shortness of Breath (SOB)
- Hemothorax,
- Pneumothorax
- Flail chest
- Intubation required
- Mechanical ventilation required
- Opioids required for pain
- Chest tube placement required
Measured: Past 4 years
Pain levels
Measured: Past 4 years
Patient Characteristics
- Clinical history of
- Rib fractures
- Other fractures
- Osteoporosis
- Chronic Obstructive Pulmonary Disease (COPD)
- Cancer
- Myocardial Infarction (MI) / Coronary Artery Disease (CAD)
- Arthritis
- Parkinson's disease
- Patient characteristics:
- Age
- Gender
- Race
- Body Mass Index (BMI)
- Alcohol use
- Smoking status
- Marital status
- Education
- Initial blood pressure
Measured: past 4 years
Current patient quality of life as assessed by telephone survey
Follow-up phone calls
The investigators will then attempt to call the patients for follow-up information using a summary explanation of research phone script to obtain the following information:
- pain score
- quality of life via the EuroQol's quality of life survey :EQ-5D-3L questionnaire
- pain meds
Measured: past 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study startJun 2013
- Primary completion30 Oct 2016
- Study completion14 Dec 2017
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.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 921 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julia Caldwell, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02487264
- Sponsor's protocol ID
- 1125
- Status last verified
- Jun 2018
- First submitted
- 5 Apr 2015
- Last updated
- 20 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Status, Treatment and Outcomes of Rib Fractures
- ClinicalTrials.gov ID
- NCT02487264
- Acronym / sponsor ID
- 1125
- Conditions
- Rib Fracture, Trauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 921 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- Jun 2013 (actual)
- Primary completion
- 30 Oct 2016 (actual)
- Study completion
- 14 Dec 2017 (actual)
- First posted
- 1 Jul 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.
A retrospective analysis of all patient presenting with multiple rib fractures to the emergency room of Penn State Hershey Medical Center between 2010-2012. Patient demographics, cause of fracture, outcomes, chronic medical conditions, vital signs, length of stay, pain levels and treatment, and sequelae will be recorded and analyzed.
Detailed description
This is a retrospective chart review with follow-up phone calls.
The initial part of the study will be a retrospective chart review. For this chart review study, the following data elements will be entered for each participant.
The investigators will perform a retrospective study of patients who have been treated for rib fractures at Penn State Hershey Medical Center (PSHMC). The time period of review will be 1/10/10 - 1/10/12 until 1500 cases have been reviewed. Data collected will be:
- Patient Medical Record Number (MRN)
- Name
- Phone number
- length of stay (admit and discharge date)
- Number of rib fractures per patient
- Cause of rib fracture
- Characteristics of the fracture (unilateral versus bilateral and multiple versus single)
- Pain management used for the rib fracture including pain interventions, medications and all pain scores
- Complications attributable to the rib fracture, including:
- Shortness of Breath (SOB)
- Hemothorax,
- Pneumothorax
- Flail chest
- Intubation required
- Mechanical ventilation required
- Opioids required for pain
- Chest tube placement required
- Sequelae of rib fracture, including:
- Acute Respiratory Deficiency Syndrome (ARDS)
- Pneumonia
- Death
- chronic pain
- delayed subclavian vessel thrombosis
- aortic aneurysm
- tracheobronchial fistula
- thoracic outlet syndrome
- Horner's syndrome
- Clinical history of
- Rib fractures
- Other fractures
- Osteoporosis
- Chronic Obstructive Pulmonary Disease (COPD)
- Cancer
- Myocardial Infarction (MI) / Coronary Artery Disease (CAD)
- Arthritis
- Parkinson's disease
- Patient characteristics:
- Age
- Gender
- Race
- Body Mass Index (BMI)
- Alcohol use
- Smoking status
- Marital status
- Education
- Initial blood pressure
7.2.2 Follow-up phone calls
The investigators will then attempt to call the patients for follow-up information using a summary explanation of research phone script to obtain the following information:
- pain score
- quality of life via the EuroQol's quality of life survey :EQ-5D-3L questionnaire
- pain meds
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients presenting during 2010-2012 with multiple rib fractures to PSHMC emergency department
Key inclusion criteria (1 listed)
- must have above and be notated in our medical record
Key exclusion criteria (1 listed)
- missing data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Types and treatment of Rib Fractures
Time frame: Past 4 years
* Characteristics of the fracture (unilateral versus bilateral and multiple versus single) * Pain management used for the rib fracture including pain interventions, medications and all pain scores
4 secondary outcomes
sequelae and complications from rib fractures
Time frame: Past 4 years
Pain levels
Time frame: Past 4 years
Patient Characteristics
Time frame: past 4 years
Current patient quality of life as assessed by telephone survey
Time frame: past 4 years
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 20 Jun 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Rib Fracture and Trauma, run by Milton S. Hershey Medical Center.
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 1 inclusion and 1 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 20 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Types and treatment of Rib Fractures (time frame: Past 4 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 20 Jun 2018.