Minimal Invasive Approach for Surgical Repair of Rib Fractures With a Novel Intrathoracic Device (RF-Advantage)

Zimmer Biomet

Status: Withdrawn

Conditions: Rib Fracture Multiple

Treatments: Device: RibFix Advantage

Study type: Observational

Funder types: Industry

Identifiers

NCT04163224

0719-2

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)