RibFix Advantage™ Post-Market Follow-Up (ZB-PIONEER)

Zimmer Biomet

Status

Terminated

Conditions

Rib Fractures

Treatments

Device: RibFix Advantage

Study type

Observational

Funder types

Industry

Identifiers

NCT05179005

0719-02

Details and patient eligibility

About

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

Full 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

Enrollment

1 patient

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

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 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)