Trauma ChestSSRFNCT04081233
Surgical Stabilization for Rib Fractures
A study testing surgical stabilization in people with Trauma Chest and Rib Fracture Multiple, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to compare the usual care alone to usual care plus early surgical stabilization in adult trauma patients who have been admitted with rib fractures, to evaluate for heterogeneity of treatment effect in high risk subgroups and to determine the the impact of multiple rib fractures on… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Trauma Chest, Rib Fracture Multiple
- What is being tested?
- surgical stabilization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Feb 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Blunt trauma mechanism
- Severe chest wall injury (defined by one of the 3 below):
- Radiographic flail segment (defined as greater than 2 fractures in greater than 3 consecutive ribs) or greater than 5 consecutive rib fractures or greater than 1 rib fractures with bicortical displacement
- At least one true rib (1-7) fractured and accessible for stabilization
Who cannot join
- Severe traumatic brain injury (best resuscitated GCS less than 8 as measured at 24 hours)
- Spinal cord injury
- Pre-existing congestive heart failure or oxygen-dependent pulmonary disease
- Any reason for which SSRF could not occur within 72 hours of admission
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: The Effect of Early Stabilization of Rib Fractures on Patient-Centered Outcomes: A Randomized Clinical Trial
The purpose of this study is to compare the usual care alone to usual care plus early surgical stabilization in adult trauma patients who have been admitted with rib fractures, to evaluate for heterogeneity of treatment effect in high risk subgroups and to determine the the impact of multiple rib fractures on post-discharge health status and time to return to work or usual physical activity.
- Conditions
- Trauma Chest, Rib Fracture Multiple
- Being tested
- surgical stabilization, Usual care
- Medical subject headings
- Thoracic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical stabilizationProcedure or surgery
Also called Rib plating
Surgical procedure utilizing any commercially available internal rib fixation system
Usual careProcedure or surgery
Usual care typically consists of breathing exercises and pain control,often including opioids
| Study group | Role | What they receive |
|---|---|---|
| Early surgical stabilization | Experimental | This arm will include early surgical stabilization (within 72 hours of admission) in addition to the usual care received for patients with multiple rib fractures. Usual care will involve pain management. Receives: Procedure: surgical stabilization |
| Usual care | Active comparator | This arm will be usual care only. Usual care will include pain managment. Receives: Procedure: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Length of Stay
Number of days patient is in the hospital
Measured: 180 days after admission
Secondary outcomes (27)
Mortality
Death following trauma injury involving rib fractures
Measured: 180 days after admission
Incidence of Respiratory Failure Requiring Mechanical Ventilation Greater Than 24 Hours
number of patients who require mechanical ventilation greater than 24 hours
Measured: 24 hours after hospital admission
Number of Patients Requiring Tracheostomy
Number of patients requiring a tracheostomy due to prolonged mechanical ventilation
Measured: Hospital discharge (about 20 to 30 days)
Number of Patients Who Developed Pneumonia During the Hospitalization
Number of patients diagnosed with pneumonia with greater than 10,000 cfu/ml on bronchioalveolar lavage or clinical diagnosis of pneumonia with subsequent antibiotic coverage
Measured: 6 months after admission
Number of Patients Who Received Regional Analgesia
Number of patients utilizing regional analgesia, such as epidural, paravertebral, intercostal or serratus plane anesthesia
Measured: 6 months after admission
Opioid Usage
Opioid usage is reported in milligrams per patient pre-randomization
Measured: Baseline
Opioid Usage
Opioid usage is reported in milligrams per patient from admission to discharge
Measured: Hospital discharge (about 20 to 30 days)
Ventilator Free Days
Number of inpatient hospital days patients did not require mechanical ventilation
Measured: Hospital discharge (about 20 to 30 days)
Intensive Care Unit (ICU) Free Days
Number of inpatient hospital days patient was not in ICU in the first 30 days
Measured: Hospital discharge (about 20 to 30 days)
Hospital (ICU) Free Days
Number of days patient was not in the hospital during the first 30 days after admission.
Measured: 30 days post admission
Re-intervention Rates for Surgical Complications
The number of times a procedure was required to treat surgical complications
Measured: 180 days post admission
Health Status as Assessed by Visual Analog Scale (VAS) Score on the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L)
Health status will be assessed by the Visual Analog Scale (VAS) Score on the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L). The Euro QoL 5-D 5-L VAS score is directly reported by participants and ranges from 0 (the worst imaginable health) to 100 (the best imaginable health). A higher score indicates a better outcome.
Measured: 30 days post admission
Health Status as Assessed by Visual Analog Scale (VAS) Score on the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L)
Health status will be assessed by the Visual Analog Scale (VAS) Score on the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L). The Euro QoL 5-D 5-L VAS score is directly reported by participants and ranges from 0 (the worst imaginable health) to 100 (the best imaginable health). A higher score indicates a better outcome.
Measured: 90 days post admission
Health Status as Assessed by Visual Analog Scale (VAS) Score on the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L)
Health status will be assessed by the Visual Analog Scale (VAS) Score on the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L). The Euro QoL 5-D 5-L VAS score is directly reported by participants and ranges from 0 (the worst imaginable health) to 100 (the best imaginable health). A higher score indicates a better outcome.
Measured: 180 days post admission
Health Status as Assessed by Index Score on the Euroqol-5D-5L
Health Status will be assessed by the index score on the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L). The Euro QoL 5-D 5-L index score ranges from 0 (a state as bad as being dead) to 1 (full health), and it is a summary score based on societal preference weights for the cumulative health states measured by 5 different dimensions (Mobility, Self-care, Daily activities, Pain/Discomfort, Anxiety/ Depression). It is calculated using the 2017 United States time trade-off valuation data set. A higher score indicates a better outcome.
Measured: 30 days post admission
Health Status as Assessed by Index Score on the Euroqol-5D-5L
Health Status will be assessed by the index score on the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L). The Euro QoL 5-D 5-L index score ranges from 0 (a state as bad as being dead) to 1 (full health), and it is a summary score based on societal preference weights for the cumulative health states measured by 5 different dimensions (Mobility, Self-care, Daily activities, Pain/Discomfort, Anxiety/ Depression). It is calculated using the 2017 United States time trade-off valuation data set. A higher score indicates a better outcome.
Measured: 90 days post admission
Health Status as Assessed by Index Score on the Euroqol-5D-5L
Health Status will be assessed by the index score on the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L). The Euro QoL 5-D 5-L index score ranges from 0 (a state as bad as being dead) to 1 (full health), and it is a summary score based on societal preference weights for the cumulative health states measured by 5 different dimensions (Mobility, Self-care, Daily activities, Pain/Discomfort, Anxiety/ Depression). It is calculated using the 2017 United States time trade-off valuation data set. A higher score indicates a better outcome.
Measured: 180 days post admission
Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L
Level of impairment will be assessed for five dimensions (Mobility, Self-care, Daily activities, Pain, Anxiety) by using the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L). Each dimension is rated at five levels: no impairment (1); minor impairment (2); moderate impairment (3); severe impairment (4); and extreme impairment (5). A higher score indicates a worse outcome.
Measured: 30 days post admission
Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L
Level of impairment will be assessed for five dimensions (Mobility, Self-care, Daily activities, Pain/Discomfort, Anxiety/ Depression) by using the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L). Each dimension is rated at five levels: no impairment (1); minor impairment (2); moderate impairment (3); severe impairment (4); and extreme impairment (5). A higher score indicates a worse outcome.
Measured: 90 days post admission
Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L
Level of impairment will be assessed for five dimensions (Mobility, Self-care, Daily activities, Pain/Discomfort, Anxiety/ Depression) by using the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L). Each dimension is rated at five levels: no impairment (1); minor impairment (2); moderate impairment (3); severe impairment (4); and extreme impairment (5). A higher score indicates a worse outcome.
Measured: 180 days post admission
Time From Injury to Return to Work
Number of days from time of injury until patient was able to return to work prior to injury per patient's assessment
Measured: 180 days post admission
Time From Injury to Resolution of Pain
Number of days from time of injury to time patient verbalized pain was resolved
Measured: 180 days post admission
Time From Injury to Return to Usual Activity
Number of days from time of injury until patient was able to return to usual activities prior to injury per patient's assessment
Measured: 180 days post admission
Number of Participants Prescribed Opioids at Discharge
Measured: Hospital discharge (about 20 to 30 days)
Number of Participants Back to Work or Normal Physical Activity
Measured: 30 days post admission
Number of Participants Back to Work or Normal Physical Activity
Measured: 90 days post admission
Number of Participants Back to Work or Normal Physical Activity
Measured: 180 days post admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start23 Feb 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Trauma ChestStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, David E. Meyer, MD, MS, FACS, The University of Texas Health Science Center, Houston
- Investigators
- David E Meyer, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04081233
- Sponsor's protocol ID
- HSC-MS-19-0649
- Other IDs
- KL2TR003168
- Acronym
- SSRF
- Status last verified
- Mar 2024
- First submitted
- 4 Sep 2019
- Last updated
- 2 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Early Stabilization of Rib Fractures on Patient-Centered Outcomes: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04081233
- Acronym / sponsor ID
- SSRF / HSC-MS-19-0649
- Conditions
- Trauma Chest, Rib Fracture Multiple
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 23 Feb 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 9 Sep 2019 (actual)
- Results
- Posted 21 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the usual care alone to usual care plus early surgical stabilization in adult trauma patients who have been admitted with rib fractures, to evaluate for heterogeneity of treatment effect in high risk subgroups and to determine the the impact of multiple rib fractures on post-discharge health status and time to return to work or usual physical activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early surgical stabilization | Experimental | Procedure: surgical stabilizationThis arm will include early surgical stabilization (within 72 hours of admission) in addition to the usual care received for patients with multiple rib fractures. Usual care will involve pain management. |
| Usual care | Active comparator | Procedure: Usual careThis arm will be usual care only. Usual care will include pain managment. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Blunt trauma mechanism
- Severe chest wall injury (defined by one of the 3 below):
- Radiographic flail segment (defined as greater than 2 fractures in greater than 3 consecutive ribs) or greater than 5 consecutive rib fractures or greater than 1 rib fractures with bicortical displacement
- At least one true rib (1-7) fractured and accessible for stabilization
Key exclusion criteria (4 listed)
- Severe traumatic brain injury (best resuscitated GCS less than 8 as measured at 24 hours)
- Spinal cord injury
- Pre-existing congestive heart failure or oxygen-dependent pulmonary disease
- Any reason for which SSRF could not occur within 72 hours of admission
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 |
|---|---|---|
| surgical stabilizationAlso: Rib platingSurgical procedure utilizing any commercially available internal rib fixation system | Procedure or surgery | Early surgical stabilization |
| Usual careUsual care typically consists of breathing exercises and pain control,often including opioids | Procedure or surgery | Usual care |
Primary outcome
Hospital Length of Stay
Time frame: 180 days after admission
Number of days patient is in the hospital
27 secondary outcomes
Mortality
Time frame: 180 days after admission
Incidence of Respiratory Failure Requiring Mechanical Ventilation Greater Than 24 Hours
Time frame: 24 hours after hospital admission
Number of Patients Requiring Tracheostomy
Time frame: Hospital discharge (about 20 to 30 days)
Number of Patients Who Developed Pneumonia During the Hospitalization
Time frame: 6 months after admission
Number of Patients Who Received Regional Analgesia
Time frame: 6 months after admission
Opioid Usage
Time frame: Baseline
Opioid Usage
Time frame: Hospital discharge (about 20 to 30 days)
Ventilator Free Days
Time frame: Hospital discharge (about 20 to 30 days)
Intensive Care Unit (ICU) Free Days
Time frame: Hospital discharge (about 20 to 30 days)
Hospital (ICU) Free Days
Time frame: 30 days post admission
Re-intervention Rates for Surgical Complications
Time frame: 180 days post admission
Health Status as Assessed by Visual Analog Scale (VAS) Score on the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L)
Time frame: 30 days post admission
Health Status as Assessed by Visual Analog Scale (VAS) Score on the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L)
Time frame: 90 days post admission
Health Status as Assessed by Visual Analog Scale (VAS) Score on the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L)
Time frame: 180 days post admission
Health Status as Assessed by Index Score on the Euroqol-5D-5L
Time frame: 30 days post admission
Health Status as Assessed by Index Score on the Euroqol-5D-5L
Time frame: 90 days post admission
Health Status as Assessed by Index Score on the Euroqol-5D-5L
Time frame: 180 days post admission
Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L
Time frame: 30 days post admission
Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L
Time frame: 90 days post admission
Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L
Time frame: 180 days post admission
Time From Injury to Return to Work
Time frame: 180 days post admission
Time From Injury to Resolution of Pain
Time frame: 180 days post admission
Time From Injury to Return to Usual Activity
Time frame: 180 days post admission
Number of Participants Prescribed Opioids at Discharge
Time frame: Hospital discharge (about 20 to 30 days)
Number of Participants Back to Work or Normal Physical Activity
Time frame: 30 days post admission
Number of Participants Back to Work or Normal Physical Activity
Time frame: 90 days post admission
Number of Participants Back to Work or Normal Physical Activity
Time frame: 180 days post admission
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
David E Meyer, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing surgical stabilization in people with Trauma Chest and Rib Fracture Multiple, run by The University of Texas Health Science Center, Houston 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 4 inclusion and 4 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 2 Apr 2024. 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?
Yes. Results are posted in the registry (first posted 21 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Hospital Length of Stay (time frame: 180 days after admission). 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 2 Apr 2024.