Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 16 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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

More Details

Status
Completed
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.