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Completed

NCT Number: NCT04081233

Surgical Stabilization for Rib Fractures

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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Key information

Conditions

Trauma Chest Rib Fracture Multiple Thoracic Injuries Wounds and Injuries

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

surgical stabilization

Procedure

Surgical procedure utilizing any commercially available internal rib fixation system

Other names: Rib plating

usual care

Procedure

Usual care typically consists of breathing exercises and pain control,often including opioids

Primary outcomes

  1. Hospital Length of Stay

    Time frame: 180 days after admission

    Number of days patient is in the hospital

Secondary outcomes

  1. Mortality

    Time frame: 180 days after admission

    Death following trauma injury involving rib fractures

  2. Incidence of Respiratory Failure Requiring Mechanical Ventilation Greater Than 24 Hours

    Time frame: 24 hours after hospital admission

    number of patients who require mechanical ventilation greater than 24 hours

  3. Number of Patients Requiring Tracheostomy

    Time frame: Hospital discharge (about 20 to 30 days)

    Number of patients requiring a tracheostomy due to prolonged mechanical ventilation

  4. Number of Patients Who Developed Pneumonia During the Hospitalization

    Time frame: 6 months after admission

    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

  5. Number of Patients Who Received Regional Analgesia

    Time frame: 6 months after admission

    Number of patients utilizing regional analgesia, such as epidural, paravertebral, intercostal or serratus plane anesthesia

  6. Opioid Usage

    Time frame: Baseline

    Opioid usage is reported in milligrams per patient pre-randomization

  7. Opioid Usage

    Time frame: Hospital discharge (about 20 to 30 days)

    Opioid usage is reported in milligrams per patient from admission to discharge

  8. Ventilator Free Days

    Time frame: Hospital discharge (about 20 to 30 days)

    Number of inpatient hospital days patients did not require mechanical ventilation

  9. Intensive Care Unit (ICU) Free Days

    Time frame: Hospital discharge (about 20 to 30 days)

    Number of inpatient hospital days patient was not in ICU in the first 30 days

  10. Hospital (ICU) Free Days

    Time frame: 30 days post admission

    Number of days patient was not in the hospital during the first 30 days after admission.

  11. Re-intervention Rates for Surgical Complications

    Time frame: 180 days post admission

    The number of times a procedure was required to treat surgical complications

  12. Health Status as Assessed by Visual Analog Scale (VAS) Score on the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L)

    Time frame: 30 days post admission

    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.

  13. Health Status as Assessed by Visual Analog Scale (VAS) Score on the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L)

    Time frame: 90 days post admission

    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.

  14. Health Status as Assessed by Visual Analog Scale (VAS) Score on the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L)

    Time frame: 180 days post admission

    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.

  15. Health Status as Assessed by Index Score on the Euroqol-5D-5L

    Time frame: 30 days post admission

    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.

  16. Health Status as Assessed by Index Score on the Euroqol-5D-5L

    Time frame: 90 days post admission

    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.

  17. Health Status as Assessed by Index Score on the Euroqol-5D-5L

    Time frame: 180 days post admission

    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.

  18. Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L

    Time frame: 30 days post admission

    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.

  19. Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L

    Time frame: 90 days post admission

    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.

  20. Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L

    Time frame: 180 days post admission

    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.

  21. Time From Injury to Return to Work

    Time frame: 180 days post admission

    Number of days from time of injury until patient was able to return to work prior to injury per patient's assessment

  22. Time From Injury to Resolution of Pain

    Time frame: 180 days post admission

    Number of days from time of injury to time patient verbalized pain was resolved

  23. Time From Injury to Return to Usual Activity

    Time frame: 180 days post admission

    Number of days from time of injury until patient was able to return to usual activities prior to injury per patient's assessment

  24. Number of Participants Prescribed Opioids at Discharge

    Time frame: Hospital discharge (about 20 to 30 days)

  25. Number of Participants Back to Work or Normal Physical Activity

    Time frame: 30 days post admission

  26. Number of Participants Back to Work or Normal Physical Activity

    Time frame: 90 days post admission

  27. Number of Participants Back to Work or Normal Physical Activity

    Time frame: 180 days post admission

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Official study title

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

Acronym: SSRF

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 9, 2019
Registry last updated
Apr 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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