RibFix Advantage™ Post-Market Follow-Up

Terminated

• Conditions: Rib Fractures
• Interventions: Device: RibFix Advantage

• Registration Number: NCT05179005
• Lead Sponsor: Zimmer Biomet

Brief 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

Detailed 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

Study Timeline

• Study First Submitted: 2021-11-30
• Study First Submitted QC: 2022-01-04
• Study First Posted: 2022-01-05
• Study Start: 2023-04-20
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-25
• Last Update Posted: 2024-01-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
RibFix Advantage	RibFix Advantage	Underwent surgical stabilization of rib fractures

Primary Outcome Measures

Name	Time	Method
Rate of re-operation	3 months post-op	Number of subjects who needed surgical re-intervention related to rib fracture repair

Secondary Outcome Measures

Name	Time	Method
Length of stay in hospital	Day 0 (surgery) to Day 7	Time spent in hospital following surgery

Trial Locations

Locations (2)

UCI Health Surgery Services; 🇺🇸 Orange, California, United States

University Hospitals Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States