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

NCT01783483 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 236

Last updated 2017-09-08

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Zimmer Biomet

    lead INDUSTRY

Principal Investigators

  • Keith B Allen, M.D. · St Luke's Mid America and Vascular Institute

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2015-06-30
Completion
2016-12-31

Countries

  • United States

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 NCT01783483 on ClinicalTrials.gov