Recruiting

Rib Fixation vs. Critical Care

Sponsor:

Darwin Ang

Code:

NCT02595593

Conditions

Rib Fracture

Flail Chest

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Rib Fixation System

Study Details

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.

Conditions

Rib Fracture

Flail Chest

Study ID

NCT02595593

Start date

Apr, 2015

Status verified date

May, 2022

Completion date

Dec, 2023

Anticipated

Primary completion date

Jan, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

236 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

active comparator: Rib Fixation System

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

no intervention: Critical Care and Pain Control

This group will receive critical care and pain control after trauma

Interventions

Rib Fixation System

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

Primary outcome measure

  • ICU Length of Stay [ Time Frame: measured through study completion, up to 2 years ]

Central Contacts and Locations

Central contacts

Donna Nayduch, RN, MSN

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

Locations

Lawnwood Regional Medical Center

Recruiting

Fort Pierce, Florida, United States, 34950

Kendall Regional Medical Center

Recruiting

Miami, Florida, United States, 33175

Ocala Regional Medical Center - Health Trauma

Recruiting

Ocala, Florida, United States, 34471

Contacts

Donna A Nayduch, RN, MSN

352-401-1022dnayduch@cfl.rr.com

Principal Investigator:

Darwin Ang, MD

Central Florida Regional Hospital

Recruiting

Sanford, Florida, United States, 32771

Contacts

William Campbell, RN

william.campbell5@hcahealthcare.com

Grand Strand Regional Medical Center

Recruiting

Myrtle Beach, South Carolina, United States, 29572

Chippenham Johnston-Willis Hospital

Recruiting

Richmond, Virginia, United States, 23225

More Information

Sponsor

Darwin Ang

Last update posted

May 10, 2022

Last verified

May, 2022

Keywords

  • Trauma
  • Rib Plate
  • Rib Fixation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Darwin Ang on 2022-05-10.