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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03282578




Registration number
NCT03282578
Ethics application status
Date submitted
12/09/2017
Date registered
14/09/2017
Date last updated
17/04/2019

Titles & IDs
Public title
Sternalock Versus Wires for Sternal Closure Study
Scientific title
Prospective Randomised Sternal Closure Study Sternalock 360 Plates vs Conventional Stainless Steel Wires
Secondary ID [1] 0 0
MH 2017.165
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac Surgery 0 0
Sternal Closure 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Sternalock 360 sternal plating system
Treatment: Devices - Sternal Wires

Active Comparator: Sternalock 360 sternal plating system - 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

Active Comparator: Sternal wires - Stainless steel sternal wires applied in a "figure of 8" configuration to close the sternum


Treatment: Devices: Sternalock 360 sternal plating system
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.

Treatment: Devices: Sternal Wires
Stainless steel wires are applied in a "figure of 8" configuration to close the sternum

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Sternal motion - Sternal edge movement with coughing that is >2 mm in any location as measured by ultrasound (US)
Timepoint [1] 0 0
6 weeks after surgery
Secondary outcome [1] 0 0
Sternal override - Anterior/posterior displacement of the sternal edges
Timepoint [1] 0 0
1 day to 3 months
Secondary outcome [2] 0 0
Sternal motion - Sternal edge movement at rest and coughing that is >2 mm in any location as measured by ultrasound (US)
Timepoint [2] 0 0
1 day to 3 months
Secondary outcome [3] 0 0
Lung ultrasound - Lung ultrasound examination for pathology
Timepoint [3] 0 0
1 day to 3 months
Secondary outcome [4] 0 0
Sternal wound infection - Any deep or superficial wound infection
Timepoint [4] 0 0
1 day to 3 months
Secondary outcome [5] 0 0
MACCE - Major adverse cerebral and cardiac events
Timepoint [5] 0 0
1 day to 3 months
Secondary outcome [6] 0 0
Sternal pain - Visual analogue pain score
Timepoint [6] 0 0
1 day to 3 months
Secondary outcome [7] 0 0
PostopQRS - Postoperative Quality of recovery scale - a multidimensional scale to measure quality of recovery after surgery
Timepoint [7] 0 0
1 day to 3 months
Secondary outcome [8] 0 0
FDQ - Functional difficulty questionaire
Timepoint [8] 0 0
1 day to 3 months
Secondary outcome [9] 0 0
Sternal closure time - Time from commencement of passage of first wire or SternaLock band to time of completion of all wire tensioning or screw fixation in plates
Timepoint [9] 0 0
1 day to 3 months
Secondary outcome [10] 0 0
Penetration of the posterior cortical bone by screws - Penetration of the posterior cortical bone by screws assessed by chest X-Ray
Timepoint [10] 0 0
6-10 days after surgery
Secondary outcome [11] 0 0
Degree of bone healing - Degree of bone healing by CT scan at 3 months after surgery
Timepoint [11] 0 0
3 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Previous sternotomy (redo) Clinical sternal deformity Home locality preventing
follow-up (e.g. remote regional, interstate or overseas patient)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Melbourne Private Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3050 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
University of Melbourne
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Zimmer Biomet
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/show/NCT03282578
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Alistair Royse, MD
Address 0 0
Melbourne Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications