NCT03282578

Brief Summary

Design: Investigator Initiated Prospective Randomised Trial Study Centre's: Melbourne Private Hospital Royal Melbourne Hospital Study Hypothesis: Use of the SternaLock 360 will reduce the incidence of sternal motion \> 2mm by absolute difference of 40% at 6 weeks of surgery compared to stainless steel wiring. Use of the SternaLock 360 will improve bone healing and quality of recovery after surgery compared to stainless steel wiring Study Objective: To determine if the SternaLock 360 system reduces sternal instability, increases bone healing, and improves quality of recovery compared to stainless steel wiring of the sternum, after cardiac surgery involving median sternotomy Inclusion Criteria: Age ≥ 18 year old Elective cardiac surgery Primary cardiac surgical procedure No evidence of infection at time of surgery Sufficient English language to complete the Postoperative Quality of Recovery Survey Exclusion Criteria: Previous sternotomy (redo) Clinical sternal deformity Home locality preventing follow-up (e.g. remote regional, interstate or overseas patient) Number of Planned Subjects: 50

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2017

Completed
21 days until next milestone

Study Start

First participant enrolled

October 5, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2018

Completed
Last Updated

April 17, 2019

Status Verified

April 1, 2019

Enrollment Period

1.1 years

First QC Date

September 12, 2017

Last Update Submit

April 15, 2019

Conditions

Cardiac SurgerySternal Closure

Keywords

sternumbone healingrecovery

Outcome Measures

Primary Outcomes (1)

  • Sternal motion

    Sternal edge movement with coughing that is \>2 mm in any location as measured by ultrasound (US)

    6 weeks after surgery

Secondary Outcomes (11)

  • Sternal override

    1 day to 3 months

  • Sternal motion

    1 day to 3 months

  • Lung ultrasound

    1 day to 3 months

  • Sternal wound infection

    1 day to 3 months

  • MACCE

    1 day to 3 months

  • +6 more secondary outcomes

Study Arms (2)

Sternalock 360 sternal plating system

ACTIVE COMPARATOR

use of the SternaLock 360 system to close the sternum: 3 plates with 3 bands and measured screw length to engage but not penetrate the posterior sternal cortex, used to close the sternum

Device: Sternalock 360 sternal plating system

Sternal wires

ACTIVE COMPARATOR

Stainless steel sternal wires applied in a "figure of 8" configuration to close the sternum

Device: Sternal Wires

Interventions

Sternalock 360 sternal plating systemDEVICE

The SternaLock 360 system is a band and plating system designed to improve sternal stability. 3 bands surround the sternum to oppose the bones (like wires), but an additional 3 plate system prevents anterior posterior displacement and provides a rigid fixation.

Sternalock 360 sternal plating system
Sternal WiresDEVICE

Stainless steel wires are applied in a "figure of 8" configuration to close the sternum

Sternal wires

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 year old Elective cardiac surgery Primary cardiac surgical procedure No evidence of infection at time of surgery Sufficient English language to complete the Postoperative Quality of Recovery Survey

You may not qualify if:

  • Previous sternotomy (redo) Clinical sternal deformity Home locality preventing follow-up (e.g. remote regional, interstate or overseas patient)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Melbourne Private Hospital

Melbourne, Victoria, 3050, Australia

Location

Related Publications (1)

  • Royse AG, El-Ansary D, Hoang W, Lui E, McCusker M, Tivendale L, Yang Y, Canty DJ, Royse CF. A randomized trial comparing the effects of sternal band and plate fixation of the sternum with that of figure-of-8 wires on sternal edge motion and quality of recovery after cardiac surgery. Interact Cardiovasc Thorac Surg. 2020 Jun 1;30(6):863-870. doi: 10.1093/icvts/ivaa040.

    PMID: 32236553DERIVED

Study Officials

  • Alistair Royse, MD

    Melbourne Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co-PI

Study Record Dates

First Submitted

September 12, 2017

First Posted

September 14, 2017

Study Start

October 5, 2017

Primary Completion

November 25, 2018

Study Completion

November 25, 2018

Last Updated

April 17, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)