Surgical Stabilization for Rib Fractures

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Early Stabilization of Rib Fractures on Patient-Centered Outcomes: A Randomized Clinical Trial

Conditions
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Trauma Chest, Rib Fracture Multiple

Intervention / Treatment
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* Procedure: surgical stabilization
* Procedure: Usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early surgical stabilization<br>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<br>* Surgical procedure utilizing any commercially available internal rib fixation system<br>* Other names: Rib plating;|
| Active Comparator: Usual care<br>This arm will be usual care only. Usual care will include pain managment. | Procedure: Usual care<br>* Usual care typically consists of breathing exercises and pain control,often including opioids<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Length of Stay | Number of days patient is in the hospital | 180 days after admission | 

Secondary Outcome Measures

| Outcome Measure | 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 | 24 hours after hospital admission | 
| Incidence of tracheostomy | number of patients requiring a tracheostomy due to prolonged mechanical ventilation | Hospital discharge | 
| Inpatient incidence of pneumonia | 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 | 
| Utilization of regional anesthesia | Number of patients utilizing regional anesthesia such as epidural, paravertebral, intercostal or serratus plane anesthesia | 6 months after admission | 
| Opioid usage | Number of patients requiring opioid medications for pain control | 6 months post admission | 
| Ventilator free days | Number of inpatient hospital days patients did not require mechanical ventilation | Hospital discharge | 
| Intensive Care Unit (ICU) free days | Number of inpatient hospital days patient was not in ICU | Hospital discharge | 
| 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 at 30 days post admission | Health status measured by the patients answers to the EuroQol-5D-5L questionnaire which is based in a scale form 0-100 with higher scores indicating a better outcome. | 30 days post admission | 
| Health status at 90 days post admission | Health status measured by the patients answers to the EuroQol-5D-5L questionnaire which is based in a scale form 0-100 with higher scores indicating a better outcome. | 90 days post admission | 
| Health status at 180 days post admission | Health status measured by the patients answers to the EuroQol-5D-5L questionnaire which is based in a scale form 0-100 with higher scores indicating a better outcome. | 180 days post admission | 
| Time from injury to return to work or usual activity | Number of days from time of injury until patient was able to return to work or usual activities 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 |