NCT01783483

An Evaluation of Rigid Sternal Fixation in Supporting Bone Healing and Improving Postoperative Recovery

An Evaluation of Rigid Sternal Fixation in Supporting Bone Healing and Improving Postoperative Recovery: A Prospective, Randomized Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 236 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate sternal bone healing following a full median sternotomy versus standard of care for sternal closure with wire cerclage. Additional outcomes on post-operative pain and analgesic usage, patient function and quality of life, and complications will also be collected. A health economics study will also be conducted, in which cost and billing data will be collected from sites participating in this clinical study.

Detailed description

Rigid sternal fixation with the BIOMET SternaLock Blu Sternal Closure System may result in greater sternal stability that leads to superior sternal bone healing, less postoperative pain and narcotic usage, and improved functional outcomes compared to wire cerclage. The health economics analysis is an interesting component of this study, in which cost and billing data will be collected from participating sites and analyzed in terms of cost/effectiveness for patients and healthcare system.

Conditions

• Coronary Artery Disease
• Angina Pectoris
• Cardiac Valve Disease

Interventions

Type	Name	Description
DEVICE	SternaLock Blue closure system	SternaLock Blue closure system is a primary closure system plate-based
DEVICE	Suture Wire	Closure system wire-based used to approximate the two halfs of the sternum following a median sternotomy.

Timeline

• Start date: 2013-01-01
• Primary completion: 2015-06-01
• Completion: 2016-12-01
• First posted: 2013-02-05
• Last updated: 2017-09-08
• Results posted: 2017-09-08

Locations

12 sites across 1 country: United States