Minimal Invasive Approach for Surgical Repair of Rib Fractures With a Novel Intrathoracic Device

Study Overview
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Brief Summary
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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
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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.

Official Title
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Minimal Invasive Approach for Surgical Repair of Rib Fractures With a Novel Intrathoracic Device. Case Series

Conditions
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Rib Fracture Multiple

Intervention / Treatment
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* Device: RibFix Advantage


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: RibFix 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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fracture stability | Evaluated by a computed tomography (CT) scan. Rib fractures repaired with RibFix Advantage should demonstrate continuity without overlap | 3 months post-implantation | 
| Device integrity | Evaluated by a computed tomography (CT) scan. Images should demonstrate no plate migration, no post/cap migration and no plate fracture | 3 months post-implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events of Interest | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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multiple rib fractures, chest stabilization, rib plates