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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05146986
Study type Observational
Source Zimmer Biomet
Contact Irene Chong
Phone 97566687
Email irene.chong@zimmerbiomet.com
Status Recruiting
Phase
Start date January 2, 2022
Completion date December 30, 2026