RibFix Advantage™ Post-Market Follow-Up

Rib Fractures Clinical Trial

— ZB-PIONEER  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05179005
• Other study ID #: 0719-02
• Status: Terminated
• Start date: April 20, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2024
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Rib Fractures

Intervention

Device:
• RibFix Advantage
Intrathoracic rib fracture stabilization

Locations

Country	Name	City	State
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	UCI Health Surgery Services	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Overall quality of life	American Chronic Pain Association Quality of Life scale	Before surgery and 3 months post-op
Other	Respiratory-related quality of life	Chronic Pulmonary Disease Assessment Test	3 months post-op
Primary	Rate of re-operation	Number of subjects who needed surgical re-intervention related to rib fracture repair	3 months post-op
Secondary	Length of stay in hospital	Time spent in hospital following surgery	Day 0 (surgery) to Day 7

External Links

•   Rib Trauma Solutions