Sternal Fracture
Conditions
Keywords
Rigid Fixation, Sternal Plating, Sternal Closure, Sternalock
Brief summary
The SternaLock 360 Sternal Closure Device combines the techniques of rigid fixation with a cerclage material into a single sternal closure system. The cerclage material serves to facilitate sternal approximation, and the plates and screws serve to provide rigid fixation and prevent sternal movement and separation. The combination of a cerclage material in combination with plate and screw fixation may also lead to increased stability compared to either method used as a standalone means of closure.
Detailed description
The purpose of this study is to evaluate a new technology for sternal closure that combines rigid plate fixation with a cerclage material in patients undergoing a cardiac surgery subsequent to a full median sternotomy. This study will evaluate intraoperative outcomes related to the surgical technique and performance of the device, sternal healing and stability, sternal wound complications and postoperative recovery (e.g. pain and functional status) in patients closed with this device. For comparative purposes, a control group of wire cerclage patients will be included.
Interventions
DEVICESternaLock 360
Sternal closure with SternaLock 360
DEVICEWire Cerclage
Sternal closure with standard wire cerclage
Sponsors
University of Cape Town
Zimmer Biomet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
participants are blinded to treatment choice until completion of the study.
Intervention model description
Comparison of intervention using sternal closure with 360 plating system, to closure of the sternum using wire cerclage
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing a standard midline sternotomy as a result of a cardiac surgical procedure (i.e. coronary artery bypass graft (CABG) and/or valve replacement along with other cardiac surgical procedures) * Patients ≥ 30 years of age * Patients who sign the Informed Consent
Exclusion criteria
Pre-Operative * Patients with endstage renal failure who are on dialysis or post transplant patients * Patients taking chronic (\>30 days) pre-operative narcotics * Patients taking chronic (\>30 days) steroids, immunosuppressant (including biologic immunosuppressants such as Enbrel), or chemotherapeutics (e.g. methotrexate). Patients using a steroid inhaler for asthma should not be excluded. * Patients with confirmed HIV with a viral load of \>10,000 copies * Patients with an active infection that is currently being treated * Patients with history or confirmed metal allergy or foreign body sensitivity * Patients with a previous partial or full midline sternotomy * Patients with previous radiation treatment of the chest * Patients defined within the New York Heart Association (NYHA) or Canadian Cardiovascular Society (CCS) functional Class IV for congestive heart failure: i.e., patients with cardiac disease resulting in inability to carry on any physical activity without discomfort (CCS ; NYHA) * Patients presenting emergent/salvage cardiac acuity as defined per the Society of Thoracic Surgeons (STS) guidelines: i.e., patients undergoing cardiopulmonary resuscitation en route to the operating room or prior to induction of anesthesia (STS) * Patients unwilling or unable to return for follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sternal Bone Healing | 6 months | Sternal bone healing score as defined by CT scan assessment at 6 months postoperatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sternal Pain | Baseline, postoperative day 3 to day 7, 1-month post-op, 3-month post-op and 6-month post-op | Pain scores obtained at pre-specified time points in 4 modalities: at rest, after using incentive spirometer, after ambulation and after forced coughing. Likert scale questionnaire. |
| Analgesic usage | Baseline, postoperative day 0 to day 7, 1-month post-op, 3-month post-op and 6-month post-op | Tabulation of all pain medication administered in pre-specified time points |
| Upper Extremities Functional Status | Baseline, 1-month post-op, 3-month post-op and 6-month post-op | Functional status of upper extremities are evaluated using 20 items that are rated on a 5-point Likert scale known as Upper Extremity Functional Index questionnaire. |
| Return to Work | Baseline, 1-month post-op, 3-month post-op and 6-month post-op | Assessment of working status of patients before and after cardiac surgery using 7-categorical question questionnaire. |
Countries
South Africa
Outcome results
None listed