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Clinical Outcomes in Patients Treated With SternaLock Blu

NCT03709693 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 156

Last updated 2021-07-23

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

SternaLock Blu

Sternal closure will be accomplished using SternaLock Blu plates and screws in combination with single-wire method of sternal reduction.

Sponsors & Collaborators

  • Zimmer Biomet

    lead INDUSTRY

Principal Investigators

  • Keith Allen, MD · St. Luke's Hospital

  • Marc Gerdisch, MD · St Franciscan Health

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-14
Primary Completion
2020-05-13
Completion
2020-05-13
FDA Device
Yes

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 NCT03709693 on ClinicalTrials.gov