Surgical Stabilization for Rib Fractures

NCT ID: NCT04081233

Last Updated: 2024-04-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-23

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Trauma Chest Rib Fracture Multiple

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

surgical stabilization

Intervention Type PROCEDURE

Surgical procedure utilizing any commercially available internal rib fixation system

Usual care

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

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type PROCEDURE

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

Interventions

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surgical stabilization

Surgical procedure utilizing any commercially available internal rib fixation system

Intervention Type PROCEDURE

Usual care

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

Intervention Type PROCEDURE

Other Intervention Names

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Rib plating

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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David E. Meyer, MD, MS, FACS

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David E Meyer, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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KL2TR003168

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HSC-MS-19-0649

Identifier Type: -

Identifier Source: org_study_id

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