Cardiac Surgery, Heart Diseases, Sternal Injury
Conditions
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 postoperative pain.
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 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.
Interventions
DEVICESteel Wires
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.
DEVICEZipFix Sternal Closure System
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.
Sponsors
Ottawa Heart Institute Research Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sternal bone healing | 3 months after surgery | Assessment of how the sternum is healing, assessed via a CT scan and classified using a 6-point scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative pain | Within 1 week of surgery | A patient's subjective assessment of their pain after surgery. |
| Use of narcotics | In the first 6 months after surgery | 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. |
| Sternal instability | In the first 6 months after surgery | Clinical assessment of patient's sternum stability after surgery |
| Sternal wound infection | In the first 6 months after surgery | The presence of sternal wound infection after surgery, confirmed by wound cultures |
| Cost | In the first 6 months after surgery. | 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. |
Countries
Canada
Outcome results
None listed