Clinical trial NCT05179005: RibFix Advantage™ Post-Market Follow-Up
Official title: Zimmer Biomet Patient Outcome and Experience After Chest Wall Repair With RibFix Advantage™
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Rib Fractures
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2022-01-05
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
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.

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

Eligibility criteria: 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)

Primary outcomes:
measure: Rate of re-operation
timeFrame: 3 months post-op
Secondary outcomes:
measure: Length of stay in hospital
timeFrame: Day 0 (surgery) to Day 7
Other outcomes:
measure: Overall quality of life
timeFrame: Before surgery and 3 months post-op
measure: Respiratory-related quality of life
timeFrame: 3 months post-op
Locations:
city: Orange
country: United States
facility: UCI Health Surgery Services
state: California
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
Study officials:
affiliation: UH Seidman Cancer Center
name: Christopher W Towe, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: 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.