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

Study Description

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.

Study Details

Registry ID:

NCT03709693

Conditions:

Cardiac Surgical Procedures, Coronary Artery Disease, Heart Valve Diseases

Phase:

Target Enrollment:

156 participants

Start Date:

May 14, 2019

Age Range:

18–100 years

Healthy Volunteers:

No

Study Locations (4 sites)

• University of Virginia
  Charlottesville, VirginiaUnited States, United States
• St. Franciscan Health
  Indianapolis, IndianaUnited States, United States
• Cardiovascular Surgery Clinic, PLLC
  Memphis, TennesseeUnited States, United States
• Saint Luke's Hospital of Kansas City
  Kansas City, MissouriUnited States, United States

Interested in Participating?

Check your eligibility and learn more about this study on TrialScreen.

View full study details and check eligibility →