Rib Fracture Multiple
Conditions
Keywords
multiple rib fractures, chest stabilization, rib plates
Brief summary
A retrospective review of demographics and adverse events from cases completed with the RibFix Advantage System. Evaluation of device integrity, and performance by a prospective CT scan with a minimum of 3 months post-implantation.
Detailed description
The RibFix Advantage System is a novel intrathoracic titanium plating system that is FDA-cleared for the treatment of rib fractures. The RibFix Advantage System is designed to be implanted in a less invasive procedure where plates are introduced and placed on the pleural cortex of the rib during video-assisted thoracoscopic surgery. Intrathoracic plate placement allows for smaller cutaneous incisions and less muscle disruption, which may aid in patient recovery compared to traditional open reduction internal fixation systems that are currently available. The purpose of this study is to gather the first clinical data on this novel device in the context of a case series of patients with radiologic and quality-of-life follow-up.
Interventions
DEVICERibFix Advantage
Class II device in the United States; consists of bridges (with locking posts) and locking caps for the thoracoscopic fixation and stabilization of ribs. These implants are manufactured from commercially pure titanium and titanium alloys. When fully assembled, the bridge plate is placed on the underside of the rib (pleural cortex); the threaded locking posts extend through pre-drilled holes in the rib, and the locking caps are fixed to the locking post on the anterior (cutaneous) side of the rib. The combined threaded locking post and cap provides for fixation of the bridge and stabilization of the fracture.
Sponsors
Zimmer Biomet
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or Female * ≥ 18 years old (no upper limit) * Underwent surgical repair of rib fracture(s) with the RibFix Advantage System alone or in combination with other systems for fracture repair * Signed Informed Consent Form for participation in a clinical trial * Willing and able to return for a follow-up visit (includes a computed tomography (CT) scan of the chest)
Exclusion criteria
* Off label use of RibFix Advantage (e.g., active or latent infection at the time of implantation, sepsis, metal sensitivity)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fracture stability | 3 months post-implantation | Evaluated by a computed tomography (CT) scan. Rib fractures repaired with RibFix Advantage should demonstrate continuity without overlap |
| Device integrity | 3 months post-implantation | Evaluated by a computed tomography (CT) scan. Images should demonstrate no plate migration, no post/cap migration and no plate fracture |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events of Interest | From the the date of implantation until the day of hospital discharge, or up to 10 days post-implantation, whichever occurs first; 30 days post surgery; 3 month post-implantation | Includes: Chest infections, Empyema, Mediastinitis. Wound infection, Wound dehiscence, Chest wall deformity related to the device, Pleural effusion related to the device, Hemothorax related to the device, Pneumothorax related to the device and Hemo-pneumothorax related to the device |
Outcome results
None listed