NCT02686099

Sternal Closure With SternaLock 360: First in Man Study

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Sternal Fracture

Interventions

Type	Name	Description
DEVICE	SternaLock 360	Sternal closure with SternaLock 360
DEVICE	Wire Cerclage	Sternal closure with standard wire cerclage

Timeline

• Start date: 2015-07-04
• Primary completion: 2017-09-05
• Completion: 2018-01-15
• First posted: 2016-02-19
• Last updated: 2018-01-18

Locations

1 site across 1 country: South Africa