An interventional study of surgical stabilization and Usual care in Trauma Chest and Rib Fracture Multiple, sponsored by The University of Texas Health Science Center, Houston. Completed at 1 site in United States. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2024-04-02.
Sponsored by The University of Texas Health Science Center, Houston · Not applicable, Interventional, and Treatment
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.
72 studies on the registry are indexed under Thoracic Injuries; 18 are open to participants now.
This study's enrollment of 84 is above the median of 72 across 37 interventional studies indexed under Thoracic Injuries.
Browse Thoracic Injuries studies →The University of Texas Health Science Center, Houston is the lead sponsor of 897 studies on the registry; 214 are open to participants now.
Of its 173 completed or terminated interventional studies of FDA-regulated products, 142 (82%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
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.
Procedure: surgical stabilization
This arm will be usual care only. Usual care will include pain managment.
Procedure: Usual care
Surgical procedure utilizing any commercially available internal rib fixation system
Also known as: Rib plating
Usual care typically consists of breathing exercises and pain control,often including opioids
Hospital Length of Stay
Number of days patient is in the hospital
Time frame: 180 days after admission
Mortality
Death following trauma injury involving rib fractures
Time frame: 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
Time frame: 24 hours after hospital admission
Number of Patients Requiring Tracheostomy
Number of patients requiring a tracheostomy due to prolonged mechanical ventilation
Time frame: 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
Time frame: 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
Time frame: 6 months after admission
Opioid Usage
Opioid usage is reported in milligrams per patient pre-randomization
Time frame: Baseline
Opioid Usage
Opioid usage is reported in milligrams per patient from admission to discharge
Time frame: Hospital discharge (about 20 to 30 days)
Ventilator Free Days
Number of inpatient hospital days patients did not require mechanical ventilation
Time frame: 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
Time frame: 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.
Time frame: 30 days post admission
Re-intervention Rates for Surgical Complications
The number of times a procedure was required to treat 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)
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.
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)
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.
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)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
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
| Milestone | Early Surgical Stabilization | Usual Care |
|---|---|---|
| Started | 42 | 42 |
| Completed | 36 | 32 |
| Not completed | 6 | 10 |
Number of days patient is in the hospital
| days | Early Surgical Stabilization | Usual Care |
|---|---|---|
| Hospital Length of Stay | 9 (6 to 20) | 6 (3 to 11) |
Death following trauma injury involving rib fractures
| Participants | Early Surgical Stabilization | Usual Care |
|---|---|---|
| Mortality | 0 | 0 |
number of patients who require mechanical ventilation greater than 24 hours
No measurements were reported for this outcome.
Number of patients requiring a tracheostomy due to prolonged mechanical ventilation
| Participants | Early Surgical Stabilization | Usual Care |
|---|---|---|
| Number of Patients Requiring Tracheostomy | 7 | 2 |
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
| Participants | Early Surgical Stabilization | Usual Care |
|---|---|---|
| Number of Patients Who Developed Pneumonia During the Hospitalization | 9 | 5 |
Number of patients utilizing regional analgesia, such as epidural, paravertebral, intercostal or serratus plane anesthesia
| Participants | Early Surgical Stabilization | Usual Care |
|---|---|---|
| Number of Patients Who Received Regional Analgesia | 7 | 3 |
Opioid usage is reported in milligrams per patient pre-randomization
| milligrams | Early Surgical Stabilization | Usual Care |
|---|---|---|
| Opioid Usage | 80 (50 to 167) | 79 (30 to 169) |
Opioid usage is reported in milligrams per patient from admission to discharge
| milligrams | Early Surgical Stabilization | Usual Care |
|---|---|---|
| Opioid usage (all) | 349 (218 to 686) | 177 (76 to 387) |
| Opioid usage (anesthesia) | 149 (92 to 266) | 0 (0 to 90) |
| Opioid usage (non-anesthesia) | 203 (89 to 477) | 125 (62 to 279) |
| Daily non-anesthesia opioid exposure | 20 (9 to 43) | 19 (9 to 34) |
Number of inpatient hospital days patients did not require mechanical ventilation
No measurements were reported for this outcome.
Number of inpatient hospital days patient was not in ICU in the first 30 days
| days | Early Surgical Stabilization | Usual Care |
|---|---|---|
| Intensive Care Unit (ICU) Free Days | 30 (20 to 30) | 30 (29 to 30) |
Number of days patient was not in the hospital during the first 30 days after admission.
| days | Early Surgical Stabilization | Usual Care |
|---|---|---|
| Hospital (ICU) Free Days | 21 (10 to 24) | 24 (19 to 27) |
The number of times a procedure was required to treat surgical complications
| Participants | Early Surgical Stabilization | Usual Care |
|---|---|---|
| Seroma | 1 | 0 |
| Surgical Site Infection | 1 | 0 |
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.
| score on a scale | Early Surgical Stabilization | Usual Care |
|---|---|---|
| Health Status as Assessed by Visual Analog Scale (VAS) Score on the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L) | 65 ± 22 | 67 ± 18 |
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.
| score on a scale | Early Surgical Stabilization | Usual Care |
|---|---|---|
| Health Status as Assessed by Visual Analog Scale (VAS) Score on the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L) | 69 ± 24 | 73 ± 23 |
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.
| score on a scale | Early Surgical Stabilization | Usual Care |
|---|---|---|
| Health Status as Assessed by Visual Analog Scale (VAS) Score on the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L) | 74 ± 23 | 77 ± 20 |
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.
| score on a scale | Early Surgical Stabilization | Usual Care |
|---|---|---|
| Health Status as Assessed by Index Score on the Euroqol-5D-5L | 0.44 ± 0.34 | 0.53 ± 0.27 |
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.
| score on a scale | Early Surgical Stabilization | Usual Care |
|---|---|---|
| Health Status as Assessed by Index Score on the Euroqol-5D-5L | 0.56 ± 0.32 | 0.61 ± 0.36 |
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.
| score on a scale | Early Surgical Stabilization | Usual Care |
|---|---|---|
| Health Status as Assessed by Index Score on the Euroqol-5D-5L | 0.69 ± 0.32 | 0.77 ± 0.26 |
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.
| score on a scale | Early Surgical Stabilization | Usual Care |
|---|---|---|
| Mobility | 3 (2 to 3) | 2 (1 to 2) |
| Self-care | 2 (2 to 3) | 2 (1 to 2) |
| Usual activities | 3 (2 to 5) | 3 (2.5 to 5) |
| Pain | 3 (2 to 3) | 3 (2 to 3) |
| Anxiety | 2 (1 to 3) | 2 (1 to 3) |
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.
| score on a scale | Early Surgical Stabilization | Usual Care |
|---|---|---|
| Mobility | 2 (1 to 3) | 1 (1 to 3) |
| Self-care | 1 (1 to 2.5) | 1 (1 to 3) |
| Usual activities | 3 (2 to 3) | 2 (1 to 3.25) |
| Pain | 3 (2 to 3) | 2 (2 to 3) |
| Anxiety | 2 (1 to 3) | 2 (1 to 2) |
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.
| score on a scale | Early Surgical Stabilization | Usual Care |
|---|---|---|
| Mobility | 1 (1 to 2) | 1 (1 to 2) |
| Self-care | 1 (1 to 1) | 1 (1 to 1) |
| Usual activities | 2 (1 to 3) | 1.5 (1 to 3) |
| Pain | 2 (2 to 3) | 2 (1 to 3) |
| Anxiety | 1 (1 to 2) | 1 (1 to 2) |
Number of days from time of injury until patient was able to return to work prior to injury per patient's assessment
| days | Early Surgical Stabilization | Usual Care |
|---|---|---|
| Time From Injury to Return to Work | 48 (35 to 89) | 43 (35 to 55) |
Number of days from time of injury to time patient verbalized pain was resolved
| days | Early Surgical Stabilization | Usual Care |
|---|---|---|
| Time From Injury to Resolution of Pain | 76 (35 to 104) | 54 (25 to 73) |
Number of days from time of injury until patient was able to return to usual activities prior to injury per patient's assessment
| days | Early Surgical Stabilization | Usual Care |
|---|---|---|
| Time From Injury to Return to Usual Activity | 92 (77 to 119) | 67 (52 to 112) |
| Participants | Early Surgical Stabilization | Usual Care |
|---|---|---|
| Tramadol | 22 | 24 |
| Other Opioid | 3 | 4 |
| Participants | Early Surgical Stabilization | Usual Care |
|---|---|---|
| Number of Participants Back to Work or Normal Physical Activity | 5 | 5 |
| Participants | Early Surgical Stabilization | Usual Care |
|---|---|---|
| Number of Participants Back to Work or Normal Physical Activity | 14 | 17 |
| Participants | Early Surgical Stabilization | Usual Care |
|---|---|---|
| Number of Participants Back to Work or Normal Physical Activity | 19 | 19 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Early Surgical Stabilization | 0/42 (0%) | 12/42 (28.6%) | 6/42 (14.3%) |
| Usual Care | 0/42 (0%) | 8/42 (19%) | 2/42 (4.8%) |
| Event | Early Surgical Stabilization | Usual Care |
|---|---|---|
| PneumoniaRespiratory, thoracic and mediastinal disorders | 9/42 | 5/42 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 1/42 | 3/42 |
| Surgical site infectionInjury, poisoning and procedural complications | 1/42 | 0/42 |
| Deep vein ThrombosisVascular disorders | 1/42 | 0/42 |
| Event | Early Surgical Stabilization | Usual Care |
|---|---|---|
| Retained HemothoraxInjury, poisoning and procedural complications | 5/42 | 2/42 |
| SeromaInjury, poisoning and procedural complications | 1/42 | 0/42 |
| Age, Continuous(years) | Early Surgical Stabilization | Usual Care | Total |
|---|---|---|---|
| Mean | 50 ± 15 | 49 ± 15 | 49.5 ± 15 |
| Sex: Female, Male(Participants) | Early Surgical Stabilization | Usual Care | Total |
|---|---|---|---|
| Female | 14 | 11 | 25 |
| Male | 28 | 31 | 59 |
| Race/Ethnicity, Customized(Participants) | Early Surgical Stabilization | Usual Care | Total |
|---|---|---|---|
| Race/Ethnicity — Caucasian, non-Hispanic | 29 | 25 | 54 |
| Race/Ethnicity — Caucasian, Hispanic | 7 | 9 | 16 |
| Race/Ethnicity — Asian | 0 | 0 | 0 |
| Race/Ethnicity — Black | 6 | 7 | 13 |
| Race/Ethnicity — Unknown | 0 | 1 | 1 |
| Region of Enrollment(participants) | Early Surgical Stabilization | Usual Care | Total |
|---|---|---|---|
| United States | 42 | 42 | 84 |
| Number of Participants Who Sustained Injury From a Motor Vehicle Collision(Participants) | Early Surgical Stabilization | Usual Care | Total |
|---|---|---|---|
| Count of participants | 24 | 19 | 43 |
| Number of Participants Who Sustained Injury From a Motorcycle Collision(Participants) | Early Surgical Stabilization | Usual Care | Total |
|---|---|---|---|
| Count of participants | 7 | 5 | 12 |
| Number of Participants Who Sustained Injury From a Fall(Participants) | Early Surgical Stabilization | Usual Care | Total |
|---|---|---|---|
| Count of participants | 3 | 6 | 9 |
| Height(centimeters) | Early Surgical Stabilization | Usual Care | Total |
|---|---|---|---|
| Mean | 174 ± 10 | 175 ± 10 | 174.5 ± 10 |
17 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
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The University of Texas Health Science Center, Houston →