CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
SternaLock 360 +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02686099
NCT02686099N/ACompleted
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SternaLock 360 First in Man Study: A Prospective, Randomized Controlled Trial

Zimmer Biomet·interventional·Posted Feb 19, 2016·Updated Jan 18, 2018

In Brief

A clinical study evaluating SternaLock 360 and Wire Cerclage for Sternal Fracture. Completed, enrolled 50 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSternal Fracture
CountriesSouth Africa
CollaboratorsUniversity of Cape Town

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 19, 2016
Enrollment StartJul 4, 2015
Primary CompletionSep 5, 2017
Study CompletionJan 15, 2018
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 10.4 years ago

Interventions

SternaLock 360device

Sternal closure with SternaLock 360

Wire Cerclagedevice

Sternal closure with standard wire cerclage