Surgical Stabilization for Rib Fractures (SSRF)

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.

Study Overview

• Status: Completed
• Conditions: Trauma Chest; Rib Fracture Multiple
• Intervention / Treatment: Procedure: surgical stabilization; Procedure: Usual care

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David E Meyer, MD; Phone Number: 713-500-7244; Email: David.E.Meyer@uth.tmc.edu
• Study Contact Backup: Name: Lily Stephens, RN; Phone Number: (713) 500-5461; Email: Lily.A.Stephens@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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
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
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 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
Number of Patients Requiring Tracheostomy	Number of patients requiring a tracheostomy due to prolonged mechanical ventilation	Hospital discharge (about 20 to 30 days)
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)
Number of Participants Prescribed Opioids at Discharge		Hospital discharge (about 20 to 30 days)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: National Center for Advancing Translational Sciences (NCATS)
• Investigators: Principal Investigator: David E Meyer, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2020
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: September 4, 2019
• First Submitted That Met QC Criteria: September 4, 2019
• First Posted (Actual): September 9, 2019

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: March 31, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Thoracic Injuries; Multiple Trauma; Fractures, Bone; Rib Fractures; Fractures, Multiple
• Other Study ID Numbers: HSC-MS-19-0649; KL2TR003168 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No