Improving Sternal Healing After Cardiac Surgery: Sternal Wire vs ZIPFIX

Study Overview
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Brief Summary
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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 postoperative pain.

Detailed Description
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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 stainless steel wires, however, new sternal fixation devices have been developed to improve sternal union. Rigid sternal fixation, although very costly, has demonstrated to be superior to standard wire cerclage both in clinical and biomechanical studies. Although improved sternal healing was observed with rigid plate fixation in a randomized controlled trial in high risk patients, the wound complication rate with plate fixation was almost double that of wire cerclage albeit not statistically significant. A novel sternal closure system denoted the sternal ZIPFIX system (DePuySynthes, Companies of Johnson and Johnson, West Over, PA, US) is biocompatible Poly-Ether-Ether-Ketone implant that was developed for fast and reliable sternal fixation following median sternotomy. First published case series utilized the sternal ZIPFIX System demonstrating effective sternal stability at 30 days. Another study has demonstrated no significant difference in the incidence of sternal wound infection following the ZIPFIX system compared to standard wire cerclage while Stelly et al., 2015 demonstrated reduced risk of deep sternal wound infection for patients using ZIPFIX. The ZIPFIX system demonstrates a higher resistance of fatigue failure and has a larger implant-to-bone contact area compared to stainless steel wires thereby reducing the risk of bone cut through. Placement of the cable ties are done similar to wire cerclage thereby not affecting time for sternal closure and training. The objective of this study is to determine whether sternal reconstruction using the ZIPFIX system compared to standard wire cerclage would improve bone healing, patient function, and decrease postoperative pain.

Official Title
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Improving Sternal Healing After Cardiac Surgery: Sternal Wire vs ZIPFIX

Conditions
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Sternal Injury, Cardiac Surgery, Heart Diseases

Intervention / Treatment
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* Device: Steel Wires
* Device: ZipFix Sternal Closure System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Steel Wires<br>In this arm, patients will have their sternum closed with steel wires. | Device: Steel Wires<br>* Control: Steel wires (device) are selected for sternal closure after surgery. Currently, most patients who have a sternotomy during cardiac surgery have their sternum closed with steel wires.<br>|
| Experimental: ZipFix Sternal Closure System (Plastic Cables)<br>In this arm, patients will have their sternum closed with the ZipFix system. | Device: ZipFix Sternal Closure System<br>* Treatment: ZipFix system (device) are selected for sternal closure after surgery. These plastic cables can also be used to close the sternum during bypass surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sternal bone healing | Assessment of how the sternum is healing, assessed via a CT scan and classified using a 6-point scale. | 3 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative pain | A patient's subjective assessment of their pain after surgery. | Within 1 week of surgery | 
| Use of narcotics | A patient's use of narcotic pain medication. To assess this measure, the proportion of patients in each group using narcotic pain medication will be compared. | In the first 6 months after surgery | 
| Sternal instability | Clinical assessment of patient's sternum stability after surgery | In the first 6 months after surgery | 
| Sternal wound infection | The presence of sternal wound infection after surgery, confirmed by wound cultures | In the first 6 months after surgery | 
| Cost | An approximation of the comparative cost of the ZipFix system versus sternal wires, which will be approximated by comparing the duration of hospital stay between groups; the use of narcotic pain medication between groups; and the rate of sternal wound infection between groups. | In the first 6 months after surgery. |