An interventional study of Steel Wires and ZipFix Sternal Closure System in Sternal Injury, Cardiac Surgery and Heart Diseases, sponsored by Ottawa Heart Institute Research Corporation. Withdrawn at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-12-17.
Sponsored by Ottawa Heart Institute Research Corporation · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
In this arm, patients will have their sternum closed with steel wires.
Device: Steel Wires
In this arm, patients will have their sternum closed with the ZipFix system.
Device: ZipFix Sternal Closure System
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.
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.
Sternal bone healing
Assessment of how the sternum is healing, assessed via a CT scan and classified using a 6-point scale.
Time frame: 3 months after surgery
Post-operative pain
A patient's subjective assessment of their pain after surgery.
Time frame: 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.
Time frame: In the first 6 months after surgery
Sternal instability
Clinical assessment of patient's sternum stability after surgery
Time frame: In the first 6 months after surgery
Sternal wound infection
The presence of sternal wound infection after surgery, confirmed by wound cultures
Time frame: 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.
Time frame: In the first 6 months after surgery.
Plan to share: No
This study is withdrawn, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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Ottawa Heart Institute Research Corporation