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| ID | Type | Description | Link |
|---|---|---|---|
| KL2TR003168 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Usual care | Active Comparator | This arm will be usual care only. Usual care will include pain managment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| surgical stabilization | Procedure | Surgical procedure utilizing any commercially available internal rib fixation system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Length of Stay | Number of days patient is in the hospital | 180 days after admission |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Death following trauma injury involving rib fractures | 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 |
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Inclusion Criteria:
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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David E Meyer, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Early Surgical Stabilization | 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. surgical stabilization: Surgical procedure utilizing any commercially available internal rib fixation system |
| FG001 | Usual Care | This arm will be usual care only. Usual care will include pain managment. Usual care: Usual care typically consists of breathing exercises and pain control,often including opioids |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Early Surgical Stabilization | 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. surgical stabilization: Surgical procedure utilizing any commercially available internal rib fixation system |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hospital Length of Stay | Number of days patient is in the hospital | Posted | Median | Inter-Quartile Range | days | 180 days after admission |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Early Surgical Stabilization | 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. surgical stabilization: Surgical procedure utilizing any commercially available internal rib fixation system |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Surgical site infection | Injury, poisoning and procedural complications | Systematic Assessment | Participants in the usual care arm are not at risk for the surgical complication of surgical site infection. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Seroma | Injury, poisoning and procedural complications | Systematic Assessment | Participants in the usual care arm are not at risk for the surgical complication of seroma. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David E. Meyer, MD, MS, FACS | The University of Texas Health Science Center at Houston | 713-500-7244 | David.E.Meyer@uth.tmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 28, 2021 | Dec 21, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 12, 2021 | Mar 2, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D013898 | Thoracic Injuries |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| Usual care | Procedure | Usual care typically consists of breathing exercises and pain control,often including opioids |
|
| 24 hours after hospital admission |
| Number of Patients Requiring Tracheostomy | Number of patients requiring a tracheostomy due to prolonged mechanical ventilation | 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 | 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 | 6 months after admission |
| Opioid Usage | Opioid usage is reported in milligrams per patient pre-randomization | Baseline |
| Opioid Usage | Opioid usage is reported in milligrams per patient from admission to discharge | Hospital discharge (about 20 to 30 days) |
| Ventilator Free Days | Number of inpatient hospital days patients did not require mechanical ventilation | 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 | 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. | 30 days post admission |
| Re-intervention Rates for Surgical Complications | The number of times a procedure was required to treat surgical complications | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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 | 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 | 180 days post admission |
| Number of Participants Prescribed Opioids at Discharge | Hospital discharge (about 20 to 30 days) |
| Number of Participants Back to Work or Normal Physical Activity | 30 days post admission |
| Number of Participants Back to Work or Normal Physical Activity | 90 days post admission |
| Number of Participants Back to Work or Normal Physical Activity | 180 days post admission |
| BG001 |
| Usual Care |
This arm will be usual care only. Usual care will include pain managment. Usual care: Usual care typically consists of breathing exercises and pain control,often including opioids |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Number of Participants Who Sustained Injury From a Motor Vehicle Collision | Count of Participants | Participants |
|
| Number of Participants Who Sustained Injury From a Motorcycle Collision | Count of Participants | Participants |
|
| Number of Participants Who Sustained Injury From a Fall | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | centimeters |
|
| Weight | Mean | Standard Deviation | kilograms |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Emergency Department Heart Rate | Mean | Standard Deviation | beats per minute |
|
| Emergency Department Respiratory Rate | Mean | Standard Deviation | breaths per minute |
|
| Emergency Department Systolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
| Emergency Department Diastolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
| Emergency Department Glasgow Coma Scale Score | The Glagcow Coma Scale (GCS) asses the level of consciousness in a person. The GSC is scored between 3 and 15, the higher the score the better outcome. | Median | Inter-Quartile Range | score on a scale |
|
| Injury Severity Score | The Injury Severity Score (ISS) asses the traumatic injury of 6 body regions. The total ISS score ranges between 1 to 75, a higher score indicating a worse outcome. | Median | Inter-Quartile Range | score on a scale |
|
| Abbreviated Injury Score Head | The Abbreviated Injury Scale (AIS) is an anatomically-based injury severity scoring system. The score ranges from 0 (no injury) to 6 (maximal), a higher score indicating a worse outcome. | Median | Inter-Quartile Range | score on a scale |
|
| Abbreviated Injury Score Face | The Abbreviated Injury Scale (AIS) is an anatomically-based injury severity scoring system. The score ranges from 0 (no injury) to 6 (maximal), a higher score indicating a worse outcome. | Median | Inter-Quartile Range | score on a scale |
|
| Abbreviated Injury Score Chest | The Abbreviated Injury Scale (AIS) is an anatomically-based injury severity scoring system. The score ranges from 0 (no injury) to 6 (maximal), a higher score indicating a worse outcome. | Median | Inter-Quartile Range | score on a scale |
|
| Abbreviated Injury Score Abdomen | The Abbreviated Injury Scale (AIS) is an anatomically-based injury severity scoring system. The score ranges from 0 (no injury) to 6 (maximal), a higher score indicating a worse outcome. | Median | Inter-Quartile Range | score on a scale |
|
| Abbreviated Injury Score Extremity | The Abbreviated Injury Scale (AIS) is an anatomically-based injury severity scoring system. The score ranges from 0 (no injury) to 6 (maximal), a higher score indicating a worse outcome. | Median | Inter-Quartile Range | score on a scale |
|
| Abbreviated Injury Score External | The Abbreviated Injury Scale (AIS) is an anatomically-based injury severity scoring system. The score ranges from 0 (no injury) to 6 (maximal), a higher score indicating a worse outcome. | Median | Inter-Quartile Range | score on a scale |
|
| Number of Participants Transferred From Another Institution | Count of Participants | Participants |
|
| Allocation Unit | Count of Participants | Participants |
|
| Time from arrival to randomizarion | Mean | Standard Deviation | hours |
|
|
|
| Secondary | Mortality | Death following trauma injury involving rib fractures | Posted | Count of Participants | Participants | 180 days after admission |
|
|
|
| Secondary | Incidence of Respiratory Failure Requiring Mechanical Ventilation Greater Than 24 Hours | number of patients who require mechanical ventilation greater than 24 hours | Data were not collected for this outcome measure | Posted | 24 hours after hospital admission |
|
|
| Secondary | Number of Patients Requiring Tracheostomy | Number of patients requiring a tracheostomy due to prolonged mechanical ventilation | Posted | Count of Participants | Participants | Hospital discharge (about 20 to 30 days) |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | 6 months after admission |
|
|
|
| Secondary | Number of Patients Who Received Regional Analgesia | Number of patients utilizing regional analgesia, such as epidural, paravertebral, intercostal or serratus plane anesthesia | Posted | Count of Participants | Participants | 6 months after admission |
|
|
|
| Secondary | Opioid Usage | Opioid usage is reported in milligrams per patient pre-randomization | Posted | Median | Inter-Quartile Range | milligrams | Baseline |
|
|
|
| Secondary | Opioid Usage | Opioid usage is reported in milligrams per patient from admission to discharge | Posted | Median | Inter-Quartile Range | milligrams | Hospital discharge (about 20 to 30 days) |
|
|
|
| Secondary | Ventilator Free Days | Number of inpatient hospital days patients did not require mechanical ventilation | Data were not collected for this outcome measure. | Posted | Hospital discharge (about 20 to 30 days) |
|
|
| Secondary | Intensive Care Unit (ICU) Free Days | Number of inpatient hospital days patient was not in ICU in the first 30 days | Posted | Median | Inter-Quartile Range | days | Hospital discharge (about 20 to 30 days) |
|
|
|
| Secondary | Hospital (ICU) Free Days | Number of days patient was not in the hospital during the first 30 days after admission. | Posted | Median | Inter-Quartile Range | days | 30 days post admission |
|
|
|
| Secondary | Re-intervention Rates for Surgical Complications | The number of times a procedure was required to treat surgical complications | Posted | Count of Participants | Participants | 180 days post admission |
|
|
|
| Secondary | 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. | Data were not collected for 5 in the early surgical stabilization arm, and data were not collected for 7 in the usual care arm. | Posted | Mean | Standard Deviation | score on a scale | 30 days post admission |
|
|
|
| Secondary | 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. | Data were not collected for 8 in the early surgical stabilization arm, and data were not collected for 10 in the usual care arm. | Posted | Mean | Standard Deviation | score on a scale | 90 days post admission |
|
|
|
| Secondary | 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. | Data were not collected for 6 in the early surgical stabilization arm, and data were not collected for 10 in the usual care arm. | Posted | Mean | Standard Deviation | score on a scale | 180 days post admission |
|
|
|
| Secondary | 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. | Data were not collected for 5 in the early surgical stabilization arm, and data were not collected for 7 in the usual care arm. | Posted | Mean | Standard Deviation | score on a scale | 30 days post admission |
|
|
|
| Secondary | 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. | Data were not collected for 8 in the early surgical stabilization arm, and data were not collected for 10 in the usual care arm. | Posted | Mean | Standard Deviation | score on a scale | 90 days post admission |
|
|
|
| Secondary | 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. | Data were not collected for 6 in the early surgical stabilization arm, and data were not collected for 10 in the usual care arm. | Posted | Mean | Standard Deviation | score on a scale | 180 days post admission |
|
|
|
| Secondary | 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. | Data were not collected for 5 in the early surgical stabilization arm, and data were not collected for 7 in the usual care arm. | Posted | Median | Inter-Quartile Range | score on a scale | 30 days post admission |
|
|
|
| Secondary | 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. | Data were not collected for 8 in the early surgical stabilization arm, and data were not collected for 10 in the usual care arm. | Posted | Median | Inter-Quartile Range | score on a scale | 90 days post admission |
|
|
|
| Secondary | 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. | Data were not collected for 6 in the early surgical stabilization arm, and data were not collected for 10 in the usual care arm. | Posted | Median | Inter-Quartile Range | score on a scale | 180 days post admission |
|
|
|
| Secondary | 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 | Data were not collected for 6 in the early surgical stabilization arm, and data were not collected for 10 in the usual care arm. | Posted | Median | Inter-Quartile Range | days | 180 days post admission |
|
|
|
| Secondary | Time From Injury to Resolution of Pain | Number of days from time of injury to time patient verbalized pain was resolved | Data were not collected for 6 in the early surgical stabilization arm, and data were not collected for 10 in the usual care arm. | Posted | Median | Inter-Quartile Range | days | 180 days post admission |
|
|
|
| Secondary | 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 | Data were not collected for 6 in the early surgical stabilization arm, and data were not collected for 10 in the usual care arm. | Posted | Median | Inter-Quartile Range | days | 180 days post admission |
|
|
|
| Secondary | Number of Participants Prescribed Opioids at Discharge | Posted | Count of Participants | Participants | Hospital discharge (about 20 to 30 days) |
|
|
|
| Secondary | Number of Participants Back to Work or Normal Physical Activity | Data were not collected for 5 in the early surgical stabilization arm, and data were not collected for 7 in the usual care arm. | Posted | Count of Participants | Participants | 30 days post admission |
|
|
|
| Secondary | Number of Participants Back to Work or Normal Physical Activity | Data were not collected for 8 in the early surgical stabilization arm, and data were not collected for 10 in the usual care arm. | Posted | Count of Participants | Participants | 90 days post admission |
|
|
|
| Secondary | Number of Participants Back to Work or Normal Physical Activity | Data were not collected for 6 in the early surgical stabilization arm, and data were not collected for 10 in the usual care arm. | Posted | Count of Participants | Participants | 180 days post admission |
|
|
|
| 0 |
| 42 |
| 12 |
| 42 |
| 6 |
| 42 |
| EG001 | Usual Care | This arm will be usual care only. Usual care will include pain managment. Usual care: Usual care typically consists of breathing exercises and pain control,often including opioids | 0 | 42 | 8 | 42 | 2 | 42 |
|
| Deep vein Thrombosis | Vascular disorders | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
|
| Retained Hemothorax | Injury, poisoning and procedural complications | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Opioid usage (non-anesthesia) |
|
| Daily non-anesthesia opioid exposure |
|
| Usual activities |
|
| Pain |
|
| Anxiety |
|
| Usual activities |
|
| Pain |
|
| Anxiety |
|
| Usual activities |
|
| Pain |
|
| Anxiety |
|