None listed
Conditions
Brief summary
A proof of concept, open-label, placement of a novel sternal band and plate fixation device with similar mechanics of stabilisation to the current routinely used band and plate system at Royal Melbourne. Evidence of adequate bone healing (proof of concept) will be assessed in the same way as the previous prospective randomised trial was conducted, with early assessment using high-frequency ultrasound imaging of the bone edges, and a CT scan at three months post operative to allow assessment of new bone formation.
Interventions
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 Commercia
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.
Sponsors
Innovate Surgical Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
Age >= 18 years old Elective cardiac surgery Primary cardiac surgical procedure No evidence of infection at the time of surgery
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
Outcome results
None listed