Surgical Stabilization for Rib Fractures (SSRF)

The University of Texas System (UT)

Status: Completed

Conditions: Rib Fracture Multiple; Trauma Chest

Treatments: Procedure: surgical stabilization; Procedure: Usual care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04081233

KL2TR003168 (U.S. NIH Grant/Contract)

HSC-MS-19-0649

Details and patient eligibility

About

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.

Enrollment: 84 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 2 patient groups

Early surgical stabilization

Experimental group

Description:

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.

Treatment:

Procedure: surgical stabilization

Usual care

Active Comparator group

Description:

This arm will be usual care only. Usual care will include pain managment.

Treatment:

Procedure: Usual care