Clinical Trial

Clinical Outcomes in Patients Treated with SternaLock Blu

Study Description

Clinical Outcomes in Patients Treated With SternaLock Blu

The primary objective of this study is to evaluate the rate of deep sternal wound infection at 30 days post-operative following a full median sternotomy in patients treated with SternaLock Blu for rigid sternal fixation. This study will also provide evidence of the clinical performance of SternaLock Blu for up to 90 days using real world evidence methodology. Sternal complications will be reported through 90 days follow up.

Location

Locations Selected Location

Methods

No pharmaceutical medication involved No pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

Device - SternaLock Blu

Sternal closure will be accomplished using SternaLock Blu plates and screws in combination with single-wire method of sternal reduction.

Additional Information

Official Study Title

Sternal Rigid Fixation: Evaluation of Clinical Outcomes Using Real-World Evidence

Clinical Trial ID

NCT03709693

ParticipAid ID

e73Xje