Surgical Stabilization for Rib Fractures

Rib Fracture Multiple Clinical Trial

— SSRF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04081233
• Other study ID #: HSC-MS-19-0649
• Secondary ID: KL2TR003168
• Status: Completed
• Phase: N/A
• Start date: February 23, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2024
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 post-discharge health status and time to return to work or usual physical activity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Rib Fracture Multiple
• Rib Fractures
• Trauma Chest

Intervention

Procedure:
• surgical stabilization
Surgical procedure utilizing any commercially available internal rib fixation system
• Usual care
Usual care typically consists of breathing exercises and pain control,often including opioids

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	National Center for Advancing Translational Sciences (NCATS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital Length of Stay	Number of days patient is in the hospital	180 days after admission
Secondary	Mortality	Death following trauma injury involving rib fractures	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	24 hours after hospital admission
Secondary	Number of Patients Requiring Tracheostomy	Number of patients requiring a tracheostomy due to prolonged mechanical ventilation	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	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	6 months after admission
Secondary	Opioid Usage	Opioid usage is reported in milligrams per patient pre-randomization	Baseline
Secondary	Opioid Usage	Opioid usage is reported in milligrams per patient from admission to discharge	Hospital discharge (about 20 to 30 days)
Secondary	Ventilator Free Days	Number of inpatient hospital days patients did not require mechanical ventilation	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	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.	30 days post admission
Secondary	Re-intervention Rates for Surgical Complications	The number of times a procedure was required to treat surgical complications	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.	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.	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.	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.	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.	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.	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.	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.	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.	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	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	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	180 days post admission
Secondary	Number of Participants Prescribed Opioids at Discharge		Hospital discharge (about 20 to 30 days)
Secondary	Number of Participants Back to Work or Normal Physical Activity		30 days post admission
Secondary	Number of Participants Back to Work or Normal Physical Activity		90 days post admission
Secondary	Number of Participants Back to Work or Normal Physical Activity		180 days post admission