Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000878471
Ethics application status
Approved
Date submitted
21/07/2025
Date registered
12/08/2025
Date last updated
12/08/2025
Date data sharing statement initially provided
12/08/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Phase 1 trial of implantation of the Sternurib device to close the sternum after sternotomy in cardiac surgery
Scientific title
Phase 1 trial of implantation of the Sternurib device to close the sternum after sternotomy in cardiac surgery
Secondary ID [1] 314958 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac Surgery 338277 0
Condition category
Condition code
Surgery 334577 334577 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The SternuRib is a novel plate-and-band medical device used to close the sternum after sternotomy for cardiac surgery. It replaces existing devices, such as stainless steel cerclage. This is the first human trial of the device's implantation in patients after cardiac surgery. The intervention will be administered by a cardiothoracic surgeon.It is likely to take 10-15 minutes to implant. There are several differentiating features, and currently available devices come. However, these are Commercial-in-confidence. There is no requirement to monitor adherence as the device is implanted as a necessity to close the sternum.The duration of implantation will be documented from the commencement until final closure of the sternum.
Intervention code [1] 331558 0
Treatment: Surgery
Comparator / control treatment
The comparator is a historical study comparing a commercially available plate and band system (SternaLock 360) and Stainless wire circlage. The endpoints are the same in this trial as for the prior study. There is no active comparator for this trial.

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;30(6):863-70
Control group
Historical

Outcomes
Primary outcome [1] 342251 0
Implant Success
Timepoint [1] 342251 0
IIntraoperative
Primary outcome [2] 342383 0
Sternal Micromotion < 2mm
Timepoint [2] 342383 0
days 1, 2, 3–5, weeks 6 and 12 postoperative
Secondary outcome [1] 450136 0
Sternal bone healing
Timepoint [1] 450136 0
12 weeks postoperative
Secondary outcome [2] 450137 0
Quality of recovery after surgery
Timepoint [2] 450137 0
1, 2, 3–5, weeks 6 and 12 postoperative

Eligibility
Key inclusion criteria
Age >= 18 years old

Elective cardiac surgery

Primary cardiac surgical procedure

No evidence of infection at the time of surgery
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous sternotomy (redo)

Clinical sternal deformity

Documented presence of osteoporosis

Home locality preventing follow-up (e.g.remote regional,interstate or overseas patient)

Unable to complete surveys in English

Patients < 50Kg or with BMI <22

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Other
Other design features
The same protocol was used in a historical study which tested both the SternaLock 360 Plate and Band System, and Stainless Steel wire Circlage.. clinicaltrials.gov NCT03282578, Royse AG, El-Ansary D, Hoang W, Lui E, McCusker M, Tivendale L et al. A randomized trial comparing the effects of sternal band and plate ?xation
of the sternum with that of ?gure-of-8 wires on sternal edge motion and quality of recovery after cardiac surgery. Interact CardioVasc Thorac Surg 2020;
doi:10.1093/icvts/ivaa040.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/08/2025
Actual
Date of last participant enrolment
Anticipated
30/01/2026
Actual
Date of last data collection
Anticipated
20/05/2026
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 28227 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 44438 0
3050 - Parkville

Funding & Sponsors
Funding source category [1] 319516 0
Commercial sector/Industry
Name [1] 319516 0
Innovate Surgical Pty Ltd
Country [1] 319516 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Innovate Surgical Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 322013 0
None
Name [1] 322013 0
None
Address [1] 322013 0
Country [1] 322013 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318091 0
The Royal Melbourne Hospital Human Research Ethics Committee
Ethics committee address [1] 318091 0
Ethics committee country [1] 318091 0
Australia
Date submitted for ethics approval [1] 318091 0
29/07/2024
Approval date [1] 318091 0
29/01/2025
Ethics approval number [1] 318091 0
2024.117 | RMH106924

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 143086 0
Prof Alistair Royse
Address 143086 0
Department of Surgery Level 6 CMR building, The Royal Melbourne hospital, Parkville 3050, Victoria
Country 143086 0
Australia
Phone 143086 0
+61 418554135
Fax 143086 0
Email 143086 0
[email protected]
Contact person for public queries
Name 143087 0
Alistair Royse
Address 143087 0
Department of Surgery Level 6 CMR building, The Royal Melbourne hospital, Parkville 3050, Victoria
Country 143087 0
Australia
Phone 143087 0
+61 418554135
Fax 143087 0
Email 143087 0
[email protected]
Contact person for scientific queries
Name 143088 0
Alistair Royse
Address 143088 0
Department of Surgery Level 6 CMR building, The Royal Melbourne hospital, Parkville 3050, Victoria
Country 143088 0
Australia
Phone 143088 0
+61 418554135
Fax 143088 0
Email 143088 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Commercial confidence



What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.