Summary

Eligibility
for people ages 18-80 (full criteria)
Location
at Orange, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Sebastian Schubl, MD

Description

Summary

To confirm safety, performance, and clinical benefits for the use of RibFix Advantage™ in the fixation, stabilization, and fusion of rib fractures and osteotomies of normal and osteoporotic bone

Official Title

Zimmer Biomet Patient Outcome and Experience After Chest Wall Repair With RibFix Advantage™

Details

Retrospective review of subject demographic and hospital data with a prospective follow-up component evaluating clinical outcomes and quality of life for patients receiving RibFix Advantage for surgical stabilization of rib fractures from 2019 to 2021

Keywords

Rib Fractures Imidacloprid RibFix Advantage

Eligibility

You can join if…

Open to people ages 18-80

  • 18-80 years of age, male or female
  • Underwent reconstruction of the chest wall between February 2019 and September 2021 with RibFix Advantage™ for the fixation, stabilization, or fusion of rib fractures
  • Minimum amount of follow-up data available, including one visit post-surgery
  • Willing and able to sign an Informed Consent for research
  • Willing and able to and complete a post-operative follow-up survey at least 3 months post-surgery

You CAN'T join if...

  • Latent or active infection with positive culture at the time of implantation
  • Documented history of metal sensitivity
  • Documented psychiatric condition preventing the patient from following post-op care instructions
  • Fixation of the first and/or second (true) vertebrosternal rib
  • Bilateral rib fractures
  • Concurrent surgical procedures (i.e. splenectomy, aortic disruption repair, diaphragm injury repair, etc.) performed during the same hospitalization
  • Lung injury (open pneumothorax, tension pneumothorax, hemothorax > 1L, pulmonary contusion requiring mechanical ventilation)

Locations

  • UCI Health Surgery Services
    Orange California 92868 United States
  • UH Seidman Cancer Center
    Cleveland Ohio 44106 United States

Lead Scientist at UC Irvine

  • Sebastian Schubl, MD
    Associate Clinical Professor, Surgery, School of Medicine. Authored (or co-authored) 91 research publications

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Zimmer Biomet
ID
NCT05179005
Study Type
Observational
Participants
Expecting 50 study participants
Last Updated