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Sternal Closure With SternaLock 360: First in Man Study

NCT02686099 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2018-01-18

No results posted yet for this study

Summary

The SternaLock 360 Sternal Closure Device combines the techniques of rigid fixation with a cerclage material into a single sternal closure system. The cerclage material serves to facilitate sternal approximation, and the plates and screws serve to provide rigid fixation and prevent sternal movement and separation. The combination of a cerclage material in combination with plate and screw fixation may also lead to increased stability compared to either method used as a standalone means of closure.

Conditions

  • Sternal Fracture

Interventions

DEVICE

SternaLock 360

Sternal closure with SternaLock 360

DEVICE

Wire Cerclage

Sternal closure with standard wire cerclage

Sponsors & Collaborators

  • University of Cape Town

    collaborator OTHER

  • Zimmer Biomet

    lead INDUSTRY

Principal Investigators

  • Brian M Hatcher, PhD · Zimmer Biomet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-04
Primary Completion
2017-09-05
Completion
2018-01-15

Countries

  • South Africa

Study Locations

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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 NCT02686099 on ClinicalTrials.gov