NCT02595593

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
236

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

10 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

April 30, 2015

Completed
6 months until next milestone

First Posted

Study publicly available on registry

November 3, 2015

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

May 10, 2022

Status Verified

May 1, 2022

Enrollment Period

7.8 years

First QC Date

April 30, 2015

Last Update Submit

May 7, 2022

Conditions

Rib FractureFlail Chest

Keywords

TraumaRib PlateRib Fixation

Outcome Measures

Primary Outcomes (1)

  • ICU Length of Stay

    length of stay in days

    measured through study completion, up to 2 years

Secondary Outcomes (3)

  • Quality of Life, as determined by SF-36 survey

    measured at 1 week, 3 months, 6 months post-intervention

  • Number of participants with pneumonia as defined by the Centers for Disease Control

    measured monthly through course of study, up to 2 years

  • Total cost of treatments

    measured through study completion, up to 2 years

Other Outcomes (8)

  • Complication Rates

    measured at 1 week, 3 months, 6 months

  • Pain Control documented by the Functional Pain Scale

    measured before and after surgery and at time of discharge, through study completion, up to 2 years

  • Ventilator/Ventilator Free Days

    measured through study completion, up to 2 years

  • +5 more other outcomes

Study Arms (2)

Rib Fixation System

ACTIVE COMPARATOR

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

Device: Rib Fixation System

Critical Care and Pain Control

NO INTERVENTION

This group will receive critical care and pain control after trauma

Interventions

Rib Fixation SystemDEVICE

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

Also known as: DePuySynthes MatrixRIB Contoured Rib Implants
Rib Fixation System

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • or more rib fractures with rib displacement of more than 1 rib cortical diameter
  • Failure to wean from ventilator

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Fort Walton Beach Medical Center

Fort Walton Beach, Florida, 32547, United States

ACTIVE NOT RECRUITING

Lawnwood Regional Medical Center

Ft. Pierce, Florida, 34950, United States

RECRUITING

Osceola Regional Medical Center

Kissimmee, Florida, 34741, United States

ACTIVE NOT RECRUITING

Kendall Regional Medical Center

Miami, Florida, 33175, United States

RECRUITING

Ocala Regional Medical Center - Health Trauma

Ocala, Florida, 34471, United States

RECRUITING

Orange Park Medical Center

Orange Park, Florida, 32073, United States

ACTIVE NOT RECRUITING

Central Florida Regional Hospital

Sanford, Florida, 32771, United States

RECRUITING

Research Medical Center

Kansas City, Missouri, 64132, United States

ACTIVE NOT RECRUITING

Grand Strand Regional Medical Center

Myrtle Beach, South Carolina, 29572, United States

RECRUITING

Chippenham Johnston-Willis Hospital

Richmond, Virginia, 23225, United States

RECRUITING

MeSH Terms

Conditions

Rib FracturesFlail ChestWounds and Injuries

Condition Hierarchy (Ancestors)

Fractures, BoneThoracic Injuries

Study Officials

  • Darwin Ang, MD

    HCA Trauma Network

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Donna Nayduch, RN, MSN

CONTACT

352-401-1022donna.nayduch@hcahealthcare.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director, Medical Trauma Services, Ocala Health Trauma

Study Record Dates

First Submitted

April 30, 2015

First Posted

November 3, 2015

Study Start

April 1, 2015

Primary Completion

January 1, 2023

Study Completion

December 1, 2023

Last Updated

May 10, 2022

Record last verified: 2022-05

Locations

US(10)