Rib Fixation for Clinically Severe Rib Fractures From Trauma

NCT ID: NCT02595593

Last Updated: 2022-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

236 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2023-12-31

Brief Summary

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This is a multicenter randomized study investigating the differences in clinical outcomes of patients between two standard of care pathways for rib trauma: patients who receive rib fixation versus patients who receive modern critical care and pain control after sustaining clinically significant rib fractures from trauma.

Detailed Description

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This study will compare the outcomes of patients between two standard of care pathways for rib trauma: those who have their ribs plated versus those who are managed by modern critical care and pain control. A study nurse (project) coordinator will identify subjects based on inclusion and exclusion criteria, then obtain consent for each of these patients prior to randomization. Randomization will be decided by a web-based computer program, accessible to the project coordinator. Although this randomization occurs, the study itself is purely observational, as the intervention is currently standard of care. None of the subjects or study group members will be blinded since it is not possible to disguise the intervention. Patients will be evaluated and a survey will be administered at set post-intervention intervals to determine endpoints and quality of life when data analysis will also take place.

Conditions

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Rib Fracture Flail Chest

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Rib Fixation System

This group of subjects will receive a surgical rib plating procedure after trauma

Group Type ACTIVE_COMPARATOR

Rib Fixation System

Intervention Type DEVICE

This intervention involves a surgical procedure to affix rib plates to broken ribs

Critical Care and Pain Control

This group will receive critical care and pain control after trauma

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Rib Fixation System

This intervention involves a surgical procedure to affix rib plates to broken ribs

Intervention Type DEVICE

Other Intervention Names

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DePuySynthes MatrixRIB Contoured Rib Implants

Eligibility Criteria

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Inclusion Criteria

* Flail chest, defined as 3 or more consecutive ribs fractured in more than one place
* Pain and disability of an FPS (Functional Pain Scale) rating of 3 or higher
* Deformity and Defect
* Non-Union
* Thoracotomy for other indications
* 3 or more rib fractures with rib displacement of more than 1 rib cortical diameter
* Failure to wean from ventilator

Exclusion Criteria

* Active bacteremia
* Active shock
* Severe Traumatic Brain Injury with GCS \< 8
* Age 17 years or less or age greater than 90 years old
* Chronic pulmonary disease requiring home oxygenation
* Acute Respiratory Distress Syndrome
* Penetrating chest trauma
* Chronic opioid dependence
* Fractures less than 3cm from vertebral spine
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Darwin Ang

OTHER

Sponsor Role lead

Responsible Party

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Darwin Ang

Director, Medical Trauma Services, Ocala Health Trauma

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Darwin Ang, MD

Role: PRINCIPAL_INVESTIGATOR

HCA Trauma Network

Locations

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Fort Walton Beach Medical Center

Fort Walton Beach, Florida, United States

Site Status ACTIVE_NOT_RECRUITING

Lawnwood Regional Medical Center

Ft. Pierce, Florida, United States

Site Status RECRUITING

Osceola Regional Medical Center

Kissimmee, Florida, United States

Site Status ACTIVE_NOT_RECRUITING

Kendall Regional Medical Center

Miami, Florida, United States

Site Status RECRUITING

Ocala Regional Medical Center - Health Trauma

Ocala, Florida, United States

Site Status RECRUITING

Orange Park Medical Center

Orange Park, Florida, United States

Site Status ACTIVE_NOT_RECRUITING

Central Florida Regional Hospital

Sanford, Florida, United States

Site Status RECRUITING

Research Medical Center

Kansas City, Missouri, United States

Site Status ACTIVE_NOT_RECRUITING

Grand Strand Regional Medical Center

Myrtle Beach, South Carolina, United States

Site Status RECRUITING

Chippenham Johnston-Willis Hospital

Richmond, Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Donna Nayduch, RN, MSN

Role: CONTACT

352-401-1022

Facility Contacts

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Jamie Santos, RN

Role: primary

Mark McKenney, MD

Role: primary

Donna A Nayduch, RN, MSN

Role: primary

352-401-1022

William Campbell, RN

Role: primary

Heather Rhodes, RN

Role: primary

Stanley Kurek, DO

Role: primary

Other Identifiers

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SCRI HEOR_02

Identifier Type: -

Identifier Source: org_study_id

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