Clinical trial NCT04081233: Surgical Stabilization for Rib Fractures
Official title: The Effect of Early Stabilization of Rib Fractures on Patient-Centered Outcomes: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trauma Chest
Rib Fracture Multiple
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2019-09-09
Enrollment: 84
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Hospital Length of Stay
timeFrame: 180 days after admission
Secondary outcomes:
measure: Mortality
timeFrame: 180 days after admission
measure: Incidence of Respiratory Failure Requiring Mechanical Ventilation Greater Than 24 Hours
timeFrame: 24 hours after hospital admission
measure: Number of Patients Requiring Tracheostomy
timeFrame: Hospital discharge (about 20 to 30 days)
measure: Number of Patients Who Developed Pneumonia During the Hospitalization
timeFrame: 6 months after admission
measure: Number of Patients Who Received Regional Analgesia
timeFrame: 6 months after admission
measure: Opioid Usage
timeFrame: Baseline
measure: Opioid Usage
timeFrame: Hospital discharge (about 20 to 30 days)
measure: Ventilator Free Days
timeFrame: Hospital discharge (about 20 to 30 days)
measure: Intensive Care Unit (ICU) Free Days
timeFrame: Hospital discharge (about 20 to 30 days)
measure: Hospital (ICU) Free Days
timeFrame: 30 days post admission
measure: Re-intervention Rates for Surgical Complications
timeFrame: 180 days post admission
measure: Health Status as Assessed by Visual Analog Scale (VAS) Score on the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L)
timeFrame: 30 days post admission
measure: Health Status as Assessed by Visual Analog Scale (VAS) Score on the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L)
timeFrame: 90 days post admission
measure: Health Status as Assessed by Visual Analog Scale (VAS) Score on the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L)
timeFrame: 180 days post admission
measure: Health Status as Assessed by Index Score on the Euroqol-5D-5L
timeFrame: 30 days post admission
measure: Health Status as Assessed by Index Score on the Euroqol-5D-5L
timeFrame: 90 days post admission
measure: Health Status as Assessed by Index Score on the Euroqol-5D-5L
timeFrame: 180 days post admission
measure: Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L
timeFrame: 30 days post admission
measure: Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L
timeFrame: 90 days post admission
measure: Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L
timeFrame: 180 days post admission
measure: Time From Injury to Return to Work
timeFrame: 180 days post admission
measure: Time From Injury to Resolution of Pain
timeFrame: 180 days post admission
measure: Time From Injury to Return to Usual Activity
timeFrame: 180 days post admission
measure: Number of Participants Prescribed Opioids at Discharge
timeFrame: Hospital discharge (about 20 to 30 days)
measure: Number of Participants Back to Work or Normal Physical Activity
timeFrame: 30 days post admission
measure: Number of Participants Back to Work or Normal Physical Activity
timeFrame: 90 days post admission
measure: Number of Participants Back to Work or Normal Physical Activity
timeFrame: 180 days post admission
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: David E Meyer, MD
role: PRINCIPAL_INVESTIGATOR
References: