Sternal Closure With SternaLock 360: First in Man Study — SL360  

Sternal Fracture Clinical Trial

Official title: SternaLock 360 First in Man Study: A Prospective, Randomized Controlled Trial

Status Completed

Clinical Trial Summary

The SternaLock 360 Sternal Closure Device combines the techniques of rigid fixation with a cerclage material into a single sternal closure system. The cerclage material serves to facilitate sternal approximation, and the plates and screws serve to provide rigid fixation and prevent sternal movement and separation. The combination of a cerclage material in combination with plate and screw fixation may also lead to increased stability compared to either method used as a standalone means of closure.

Clinical Trial Description

The purpose of this study is to evaluate a new technology for sternal closure that combines rigid plate fixation with a cerclage material in patients undergoing a cardiac surgery subsequent to a full median sternotomy. This study will evaluate intraoperative outcomes related to the surgical technique and performance of the device, sternal healing and stability, sternal wound complications and postoperative recovery (e.g. pain and functional status) in patients closed with this device. For comparative purposes, a control group of wire cerclage patients will be included. ;

Related Conditions & MeSH terms

• Sternal Fracture

• NCT number: NCT02686099
• Study type: Interventional
• Source: Zimmer Biomet
• Status: Completed
• Phase: N/A
• Start date: July 4, 2015
• Completion date: January 15, 2018