NCT00819286

Evaluation of Primary Plating in Sternotomy Patients for Osteosynthesis and Pain

A Prospective, Randomized-Controlled, Multicenter Study Evaluating Primary Plating in High-Risk Median Sternotomy Patients for Osteosynthesis and Pain

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to evaluate sternal osteosynthesis, chest wall pain and return to normal activity in open heart surgery patients who had their breast bone closed either with wires or plates.

Detailed description

Median sternotomy patients will be randomized to either wire or rigid fixation groups. A scheduled evaluation period will record clinical parameters. Enrollment has ended with one hundred forty (140) patients.

Conditions

• Sternal Wound Infection
• Sternal Non-union
• Pain
• Mediastinitis

Interventions

Type	Name	Description
DEVICE	SternaLock Rigid Fixation Plates	patients will have their sternum closed by rigid fixation using SternaLock Rigid Fixation Plates
DEVICE	wire (control)	patients will have their sternum closed using wire (stainless steel surgical wire).

Timeline

• Start date: 2008-11-01
• Primary completion: 2011-01-01
• Completion: 2011-12-01
• First posted: 2009-01-08
• Last updated: 2018-02-13
• Results posted: 2012-03-15

Locations

6 sites across 2 countries: United States, Germany