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

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

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

Study Overview

• Status: Terminated
• Conditions: Rib Fractures
• Intervention / Treatment: Device: RibFix Advantage

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 Type: Observational
• Enrollment (Actual): 1

Contacts and Locations

Study Locations

• United States
  • California
    • Orange, California, United States, 92868
      • UCI Health Surgery Services
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Thoracic trauma comprises 20-25% of all traumas worldwide and constitutes the third most common cause of death after abdominal injury and head trauma in polytrauma patients.

Thoracic trauma directly accounts for approximately 25% of trauma-related mortality and is a contributing factor in another 25% of such cases. The incidence of rib fractures due to trauma has been reported by various studies to range between 7 and 40%.

There is no standard treatment for rib fractures, though there are several options. Failure to treat rib fracture pain can lead to reduced movement, cough suppression, and secondary infection.

The conservative option for caring for a rib fracture involves the non-operative management of pain.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
RibFix Advantage; Underwent surgical stabilization of rib fractures	Device: RibFix Advantage; Intrathoracic rib fracture stabilization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of re-operation	Number of subjects who needed surgical re-intervention related to rib fracture repair	3 months post-op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of stay in hospital	Time spent in hospital following surgery	Day 0 (surgery) to Day 7

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall quality of life	American Chronic Pain Association Quality of Life scale	Before surgery and 3 months post-op
Respiratory-related quality of life	Chronic Pulmonary Disease Assessment Test	3 months post-op

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Principal Investigator: Christopher W Towe, MD, UH Seidman Cancer Center

Publications and helpful links

General Publications

• Nirula R, Allen B, Layman R, Falimirski ME, Somberg LB. Rib fracture stabilization in patients sustaining blunt chest injury. Am Surg. 2006 Apr;72(4):307-9. doi: 10.1177/000313480607200405.
• Tanaka H, Yukioka T, Yamaguti Y, Shimizu S, Goto H, Matsuda H, Shimazaki S. Surgical stabilization of internal pneumatic stabilization? A prospective randomized study of management of severe flail chest patients. J Trauma. 2002 Apr;52(4):727-32; discussion 732. doi: 10.1097/00005373-200204000-00020.
• Granetzny A, Abd El-Aal M, Emam E, Shalaby A, Boseila A. Surgical versus conservative treatment of flail chest. Evaluation of the pulmonary status. Interact Cardiovasc Thorac Surg. 2005 Dec;4(6):583-7. doi: 10.1510/icvts.2005.111807. Epub 2005 Sep 15.
• Campbell N, Conaglen P, Martin K, Antippa P. Surgical stabilization of rib fractures using Inion OTPS wraps--techniques and quality of life follow-up. J Trauma. 2009 Sep;67(3):596-601. doi: 10.1097/TA.0b013e3181ad8cb7.

Helpful Links

• Rib Trauma Solutions

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2023
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: November 30, 2021
• First Submitted That Met QC Criteria: January 4, 2022
• First Posted (Actual): January 5, 2022

Study Record Updates

• Last Update Posted (Estimated): January 29, 2024
• Last Update Submitted That Met QC Criteria: January 25, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Thoracic Injuries; Rib Fractures; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Imidacloprid
• Other Study ID Numbers: 0719-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes