RibFix Advantage™ Post-Market Follow-Up

Last updated: January 25, 2024
Sponsor: Zimmer Biomet
Overall Status: Terminated

Phase

N/A

Condition

Chest Trauma

Treatment

RibFix Advantage

Clinical Study ID

NCT05179005
0719-02
  • Ages 18-80
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18-80 years of age, male or female
  • Underwent reconstruction of the chest wall between February 2019 and September 2021with 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 monthspost-surgery

Exclusion

Exclusion Criteria:

  • 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 careinstructions
  • Fixation of the first and/or second (true) vertebrosternal rib
  • Bilateral rib fractures
  • Concurrent surgical procedures (i.e. splenectomy, aortic disruption repair, diaphragminjury repair, etc.) performed during the same hospitalization
  • Lung injury (open pneumothorax, tension pneumothorax, hemothorax > 1L, pulmonarycontusion requiring mechanical ventilation)

Study Design

Total Participants: 1
Treatment Group(s): 1
Primary Treatment: RibFix Advantage
Phase:
Study Start date:
April 20, 2023
Estimated Completion Date:
December 31, 2023

Study Description

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

Connect with a study center

  • UCI Health Surgery Services

    Orange, California 92868
    United States

    Site Not Available

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Site Not Available

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