Rib Fractures
Conditions
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
Interventions
DEVICERibFix Advantage
Intrathoracic rib fracture stabilization
Sponsors
Zimmer Biomet
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of re-operation | 3 months post-op | Number of subjects who needed surgical re-intervention related to rib fracture repair |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of stay in hospital | Day 0 (surgery) to Day 7 | Time spent in hospital following surgery |
Other
| Measure | Time frame | Description |
|---|---|---|
| Overall quality of life | Before surgery and 3 months post-op | American Chronic Pain Association Quality of Life scale |
| Respiratory-related quality of life | 3 months post-op | Chronic Pulmonary Disease Assessment Test |
Countries
United States
Outcome results
None listed