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Evaluation of Primary Plating in Sternotomy Patients for Osteosynthesis and Pain

NCT00819286 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2018-02-13

Study results available
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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.

Conditions

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

Interventions

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).

Sponsors & Collaborators

  • Zimmer Biomet

    lead INDUSTRY

Principal Investigators

  • Jai Raman, MD · University of Chicago

  • Michael Wong, MD · University of California Davis Medical Center, Sacramento, CA

  • Brian DeGuzmann, MD · St. Joseph's Medical Center, Phoenix, AZ

  • Sven Lehmann, MD · Leipzig Heart Center, Leipzig, Germany

  • Kenton Zehr, MD · Scott & White Memorial Hospital, Temple, TX

  • H Edward Garrett, Jr, MD · Baptist Memorial Hospital, Memphis, TN

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2011-01-31
Completion
2011-12-31

Countries

  • United States
  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00819286 on ClinicalTrials.gov