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

Withdrawn

• Conditions: Rib Fracture Multiple

• Registration Number: NCT04163224
• Lead Sponsor: Zimmer Biomet

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.

Study Timeline

• Study First Submitted: 2019-11-08
• Study First Submitted QC: 2019-11-13
• Study First Posted: 2019-11-14
• Study Start: 2020-04-01
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-28
• Primary Completion: 2020-08-30
• Last Update Posted: 2020-09-01
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
Fracture stability	3 months post-implantation	Evaluated by a computed tomography (CT) scan. Rib fractures repaired with RibFix Advantage should demonstrate continuity without overlap

Secondary Outcome Measures

Name	Time	Method
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