Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-25 @ 3:27 AM
NCT ID:
NCT05179005
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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05179005
Study Brief:
Protocol Section:
NCT05179005