Cardiac Surgery Clinical Trial
Official title:
Prospective Randomised Sternal Closure Study Sternalock 360 Plates vs Conventional Stainless Steel Wires
Verified date | April 2019 |
Source | University of Melbourne |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 50 |
Est. completion date | November 25, 2018 |
Est. primary completion date | November 25, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
Australia | Melbourne Private Hospital | Melbourne | Victoria |
Lead Sponsor | Collaborator |
---|---|
University of Melbourne | Zimmer Biomet |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sternal motion | Sternal edge movement with coughing that is >2 mm in any location as measured by ultrasound (US) | 6 weeks after surgery | |
Secondary | Sternal override | Anterior/posterior displacement of the sternal edges | 1 day to 3 months | |
Secondary | Sternal motion | Sternal edge movement at rest and coughing that is >2 mm in any location as measured by ultrasound (US) | 1 day to 3 months | |
Secondary | Lung ultrasound | Lung ultrasound examination for pathology | 1 day to 3 months | |
Secondary | Sternal wound infection | Any deep or superficial wound infection | 1 day to 3 months | |
Secondary | MACCE | Major adverse cerebral and cardiac events | 1 day to 3 months | |
Secondary | Sternal pain | Visual analogue pain score | 1 day to 3 months | |
Secondary | PostopQRS | Postoperative Quality of recovery scale - a multidimensional scale to measure quality of recovery after surgery | 1 day to 3 months | |
Secondary | FDQ | Functional difficulty questionaire | 1 day to 3 months | |
Secondary | 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 | 1 day to 3 months | |
Secondary | Penetration of the posterior cortical bone by screws | Penetration of the posterior cortical bone by screws assessed by chest X-Ray | 6-10 days after surgery | |
Secondary | Degree of bone healing | Degree of bone healing by CT scan at 3 months after surgery | 3 months |
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