Minimal Invasive Approach for Surgical Repair of Rib Fractures With a Novel Intrathoracic Device (RF-Advantage)
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|ClinicalTrials.gov Identifier: NCT04163224|
Recruitment Status : Withdrawn (Sponsor strategy change)
First Posted : November 14, 2019
Last Update Posted : September 1, 2020
|Condition or disease||Intervention/treatment|
|Rib Fracture Multiple||Device: RibFix Advantage|
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.
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||Minimal Invasive Approach for Surgical Repair of Rib Fractures With a Novel Intrathoracic Device. Case Series|
|Estimated Study Start Date :||April 1, 2020|
|Estimated Primary Completion Date :||August 30, 2020|
|Estimated Study Completion Date :||December 30, 2020|
- 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.
- Fracture stability [ Time Frame: 3 months post-implantation ]Evaluated by a computed tomography (CT) scan. Rib fractures repaired with RibFix Advantage should demonstrate continuity without overlap
- Device integrity [ Time Frame: 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
- Adverse Events of Interest [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04163224
|Study Director:||Mark Sun||Zimmer Biomet|