NCT05146986

RibFix Blu Thoracic Fixation System Versus Non-surgical Treatment in Non-flail Chest Rib Fractures

Prospective Multi-center Comparative Study of RibFix Blu Thoracic Fixation System Versus Non-surgical Treatment in Non-flail Chest Rib Fractures

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 167 (estimated)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a prospective, multi-center, observational, cohort study involving skilled cardiothoracic surgeons who are experienced in implanting the treatment of non-flail chest rib fractures and the use of RibFix Blu Thoracic Fixation System.

Detailed description

The objective of this study is to evaluate the benefits of surgical stabilization of rib fractures (SSRF) in patients with non-flail chest rib fractures using RibFix Blu Thoracic Fixation System when compared to non-surgical (analgesia and symptomatic management) treatment. The study will include up to 167 cases of non-flail chest rib fractures with 95 cases in non-surgical treatment group and 72 cases in the surgical group. Each center may enroll up to maximum 30 cases to permit the assessment of outcome across a variety investigators and clinical settings. Enrolment will be competitive among sites and closed as soon as a total of 167 cases are recruited.

Conditions

• Rib; Fracture

Interventions

Type	Name	Description
DEVICE	Non surgical and Surgical	For non-surgical group, patients will receive non-surgical treatment (analgesia and symptomatic management treatment). For surgical group, patients will receive surgical treatment using RibFix Blu Thoracic Fixation System.

Timeline

• Start date: 2022-01-02
• Primary completion: 2025-12-30
• Completion: 2026-12-30
• First posted: 2021-12-07
• Last updated: 2024-03-07

Locations

5 sites across 2 countries: Australia, South Korea

Regulatory

• FDA-regulated device study