N/A
Completed N=84
Surgical Stabilization for Rib Fractures
Trauma Chest · Rib Fracture Multiple
Source: ClinicalTrials.gov NCT04081233 ↗
Enrolled (actual)
84
Serious AEs
23.8%
Results posted
Feb 2024
Primary outcomePrimary: Hospital Length of Stay — 9; 6 days
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hospital Length of Stay |
9; 6 | — |
| SECONDARY Mortality |
0; 0 | — |
| SECONDARY Incidence of Respiratory Failure Requiring Mechanical Ventilation Greater Than 24 Hours |
— | — |
| SECONDARY Number of Patients Requiring Tracheostomy |
7; 2 | — |
| SECONDARY Number of Patients Who Developed Pneumonia During the Hospitalization |
9; 5 | — |
| SECONDARY Number of Patients Who Received Regional Analgesia |
7; 3 | — |
| SECONDARY Opioid Usage |
349; 177; 149; 0; 203; 125 | — |
| SECONDARY Ventilator Free Days |
— | — |
| SECONDARY Intensive Care Unit (ICU) Free Days |
30; 30 | — |
| SECONDARY Hospital (ICU) Free Days |
21; 24 | — |
| SECONDARY Re-intervention Rates for Surgical Complications |
1; 0; 1; 0 | — |
| SECONDARY Health Status as Assessed by Visual Analog Scale (VAS) Score on the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L) |
74; 77 | — |
| SECONDARY Health Status as Assessed by Index Score on the Euroqol-5D-5L |
0.69; 0.77 | — |
| SECONDARY Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L |
1; 1; 1; 1; 2; 1.5 | — |
| SECONDARY Time From Injury to Return to Work |
48; 43 | — |
| SECONDARY Time From Injury to Resolution of Pain |
76; 54 | — |
| SECONDARY Time From Injury to Return to Usual Activity |
92; 67 | — |
| SECONDARY Number of Participants Prescribed Opioids at Discharge |
22; 24; 3; 4 | — |
| SECONDARY Number of Participants Back to Work or Normal Physical Activity |
19; 19 | — |
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
Data sourced from ClinicalTrials.gov (NCT04081233). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.