None listed
Conditions
Brief summary
This is an Investigator led trial to assess the safety and efficacy of the Waston Sternal Claw Fixation System against Standard of Care Wire Cerclage as an advantageous of Median Sternotomy Closure. Wire cerclage has long been the gold standard and lone method of median sternotomy closure, yet this method has substantial and obvious limitations that can cause patients considerable complications post-procedure. The use of the Waston Sternal Claw Plate has been proposed as an advantageous method of sternal closure compared to all previous closure methods due to the structure of the device, however there has only been one study evaluating the effectiveness of the Waston Sternal Claw as a method of sternotomy closure against wire cerclage. As such, the purpose of this research is to justify the use of the sternal claw system as an improved method for median sternotomy closure and provide additional evidence of its benefit to patient outcomes post-sternotomy. Participants planned for Cardiac Surgery involving a Median Sternotomy method of heart access will be recruited into the study. Participants will be evaluated for their appropriateness to partake in the study and will be randomised into 1 of 3 arms of sternal closure post cardiac surgery. Participants will have their sternum closed according to the method they were randomised to and will be assessed for 6 weeks post-intervention to assess the safety and efficacy of their sternal closure method. Assessments will be conducted to assess the effectiveness of sternal closure and sternal union, participant safety and quality of life post-intervention.
Interventions
This is a study to assess the safety and efficacy of the Waston Sternal Claw Fixation System device. The safety and efficacy of the device will be assessed by randomising cardiothoracic surgery patients into different sternal closure intervention arms (Group A - 4 Waston Sternal Claw Devices, Group B - 2 Waston Sternal Claw Devices and Sternal Wires, or Group C - Sternal Wires only) and comparing their outcomes post intervention.
The intervention being assess (Sternal Claw) will be performed b
This is a study to assess the safety and efficacy of the Waston Sternal Claw Fixation System device. The safety and efficacy of the device will be assessed by randomising cardiothoracic surgery patients into different sternal closure intervention arms (Group A - 4 Waston Sternal Claw Devices, Group B - 2 Waston Sternal Claw Devices and Sternal Wires, or Group C - Sternal Wires only) and comparing their outcomes post intervention. The intervention being assess (Sternal Claw) will be performed by the operating Cardiothoracic Surgeon and will involve the surgeon firstly measuring the width of the sternum and selecting an appropriate Claw Plate size to match the participants sternum size. The appropriate claw plate is attached to a dedicated sternal closure device and hooked into the opposing intercostal spaces. The sternal closure device is tightened closing the sternum and locking the claw plate into place. The sternal closure device is removed leaving the claw plate in place and the sternum in a fully compressed and closed state. This process is repeated for however many claw plates the participant has been randomised to and the whole process is expected to take approximately 10 minutes. The safety and the efficacy of the Waston Sternal Claw Fixation System will be assessed post-intervention and will involve questionnaires to assess participants pain level and quality of life after intervention, and procedures, including sternal instability scale and ultrasound, to assess sternal union, healing, movement and instability up to 6 weeks post-intervention. These outcome measures will be the same for all arms of the trial.
Sponsors
Professor Jayme Bennetts
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
- Patients who undergo median sternotomy for any cardiac procedure - Patients aged 18-80 - Patients who have sufficient English language - Patients able to and willing to comply with all study procedures - Patient able to understand and provide informed consent
Exclusion criteria
- Patients allergic to heavy alloy - Patients undergoing re-do procedure - Patients who have chronic steroid or narcotic use - Patients with a clinical sternal deformity - Pregnant women - Patients with a body mass index greater than or equal to 40 - Patients with severe chronic obstructive airway disease - Patients with dialysis dependent renal failure. - Patients who have any of the following Sternal Claw contraindications: o Severe mental disorder o Generalized nervous disease o Immune suppression disorder o Calcified tissue metabolism disorder o Systematic or local infections o Allergic to metal materials Intra-Operative criteria - Any intra-operative condition that would preclude the use of the Sternal Claw as deemed appropriate by the treating surgeon o poor bone quality o paramedian (non midline) sternotomy o bleeding (or high likelihood of depending on case specific issues) o Sizing/technical suitability for CLAW plating system or concerns around use of routine sternal wires o Other surgical complications as assessed by operating surgeon
Outcome results
None listed