RibFix Advantage™ Post-Market Follow-Up

NCT05179005 | Terminated FDA Device

• 1 other identifier: 0719-02
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 2

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

Conditions

Rib Fractures

Outcome Measures

Primary Outcomes (1)

• Rate of re-operation

  Number of subjects who needed surgical re-intervention related to rib fracture repair

  3 months post-op

Secondary Outcomes (1)

• Length of stay in hospital

  Day 0 (surgery) to Day 7

Other Outcomes (2)

• Overall quality of life

  Before surgery and 3 months post-op

• Respiratory-related quality of life

  3 months post-op

Study Arms (1)

RibFix Advantage

Underwent surgical stabilization of rib fractures

Device: RibFix Advantage

Interventions

RibFix Advantage DEVICE

Intrathoracic rib fracture stabilization

RibFix Advantage

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (2)

UCI Health Surgery Services

Orange, California, 92868, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Related Publications (4)

• 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.

  PMID: 11956391 BACKGROUND

• 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.

  PMID: 17670487 BACKGROUND

• 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.

  PMID: 16676852 BACKGROUND

• 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.

  PMID: 19741406 BACKGROUND

Related Links

• Rib Trauma Solutions

MeSH Terms

Conditions

Rib Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Thoracic Injuries

Study Officials

• Christopher W Towe, MD

  UH Seidman Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: January 5, 2022
• Study Start: April 20, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 29, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)