Status:
WITHDRAWN
Improving Sternal Healing After Cardiac Surgery: Sternal Wire vs ZIPFIX
Lead Sponsor:
Ottawa Heart Institute Research Corporation
Conditions:
Sternal Injury
Cardiac Surgery
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective of this study is to determine whether sternal reconstruction using the ZIPFIX system compared to standard wire cerclage could improve bone healing, patient function, and decreased postop...
Detailed Description
Despite a longer time for bone healing and functional recovery, median sternotomy is still the most common approach in cardiac surgery. Sternal closure has traditionally been wire cerclage using stain...
Eligibility Criteria
Inclusion
- Patient age ≥ 18 years
- Scheduled cardiac surgery including coronary artery bypass grafting, aortic valve replacement, mitral valve replacement/repair, or ascending aorta replacement.
- Patient undergoing elective or urgent surgery
- Ability to understand study procedures and to comply with them for the entire length of the study.
Exclusion
- Patients undergoing emergent cardiac surgery
- Severe congestive heart failure (NYHA class III or IV) at enrollment
- Prior cardiac surgery
- Patients undergoing ventricular assist device insertion or heart transplantation
- Patients with a known metal allergy or allergy to ZIPFIX implant
- Patients who refuses consent
- Patients who are unable to follow post-operative instructions
- Prior history of significant bleeding that might be expected to recur with cardiac surgery
- Dementia with a mini mental status examination (MMSE) score of \< 20
- Extra cardiac illness that is expected to limit survival to less than 5 years
- Suspected pregnancy. A pregnancy test (urine or serum) will be administered to all women not clearly menopausal
- Concurrent enrollment in another clinical trial
- Geographic inaccessibility for follow-up visits required by the protocol
- Prisoners or institutionalized individuals
Key Trial Info
Start Date :
September 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03289104
Start Date
September 1 2018
End Date
September 1 2020
Last Update
December 17 2018
Active Locations (1)
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1
Division of Cardiac Surgery
Ottawa, Ontario, Canada, K1Y4W7